A Phase 3 interventional study of Ropinirole CR 2mg tablet and Ropinirole CR 8mg tablet in Parkinson Disease, sponsored by GlaxoSmithKline. Terminated at 17 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-06-20.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
This study is a Phase III, multicentre, randomized, initial double-blind study with subsequent open label phases. The study will havea screening phase (4 weeks), a dose increase effect verification phase (12 weeks), a down titration 1 phase (1 week), a long-term phase (39 weeks), down titration 2 phase (1 to 2 weeks) and a follow up phase. Subjects will be assigned to Ropinirole CR high-dose group or Ropinirole CR maintenance group at a ratio of 3:1. This study is being conducted to evaluate the efficacy (effect of increasing Ropinirole dose from 16 mg/day to 18-24 mg/day) of the Ropinirole CR tablets in early and advanced PD patients who have not achieved an optimal therapeutic response with marketed Ropinirole Immediate release (IR) (15 mg/day) or marketed Ropinirole CR (16 mg/day) formulations.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 81 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Inclusion Criteria:
Inclusion criteria at the start of the screening
Randomization Criteria
Exclusion Criteria
The subjects will receive Ropinirole CR 16mg/day for 4 weeks in screening phase. After randomization the subject will enter dose increase effect verification phase, where Ropinirole CR dose will titrated (2 mg /day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, till subject reaches a dose level above which further symptomatic improvement cannot be expected; the subject will be maintained on that dose for 4 weeks. This will be followed by a down titration phase of one week and long term phase of 39 weeks in which the subjects will receive incremental doses (2 mg /day/week) of Ropinirole CR from 18 mg/day till to a maximum of 24 mg/day till subject reaches a dose level above which further symptomatic improvement cannot be expected; the subject will be maintained on that dose. Subjects completing the long term phase will undergo a down titration phase of 1 to 2 weeks.
Drug: Ropinirole CR 2mg tablet · Drug: Ropinirole CR 8mg tablet
The subjects will receive Ropinirole CR 16mg/day for 4 weeks in screening phase. After randomization the subject will enter dose increase effect verification phase and Ropinirole CR dose will maintained at 16mg/day and placebo will be increased at intervals of 1 week for 8 weeks till subject reaches a dose level above which further symptomatic improvement cannot be expected; the subject will be maintained on that dose for 4 weeks. This will be followed by a down titration phase of one week and long term phase of 39 weeks in which the subjects will receive incremental doses (2 mg/day/week) of Ropinirole CR from 18 mg/day till to a maximum of 24 mg/day till subject reaches a dose level above which further symptomatic improvement cannot be expected; the subject will be maintained on that dose. Subjects completing the long term phase will undergo a down titration phase of 1 to 2 weeks.
Drug: Ropinirole CR 2mg tablet · Drug: Ropinirole CR 8mg tablet · Drug: Ropinirole CR matching Placebo tablet
Ropinirole CR 2mg tablets will be supplied as white oval film-coated tablets.
Ropinirole CR 8mg tablets will be supplied as white oval film-coated tablets.
Ropinirole CR matching Placebo tablet tablets (containing no active ingredients) indistinguishable in appearance from Ropinirole CR 2 mg tablets.
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group
The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
Time frame: Baseline and Week 12
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits
The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase
The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase
The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at the planned visit.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase
The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase
The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase
The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase
The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase
The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase
The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase
The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. Full Analysis Set 2 (FAS2) Population comprised of all participants in the FAS1 and shifted to Long-term Phase, excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase
The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data."Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase
The Japanese UPDRS assesses the status of PD participants objectively. Part 3 evaluates motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase
The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase
The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase
The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data."Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase
The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase
The Japanese UPDRS assesses the status of PD participants objectively. Part 4 evaluates complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "Off"(actual hours) is calculated as awake time spent "Off" (hours) at the indicated visit minus awake time spent "Off" (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Percentage of awake time spent "off" is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "off") from the post Baseline value (percentage of awake time spent "off"). Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On"(actual hours) is calculated as awake time spent "On" (hours) at the indicated visit minus awake time spent "On" (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Change From Baseline in Actual Hours of Awake Time Spent "On"Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On" without troublesome dyskinesias (actual hours) is calculated as \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at visit minus \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12
Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12
The CGI global improvement scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of \<=2 (representing much improved or very much improved) were considered to be moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Time frame: Week 12
Number of Participants Remaining in the Study
Time frame: From the start of the study medication (Week 0) until Week 52
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.
The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 17, 21, 25, 37, 49 and 52,are presented using OC data. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52
Change From Baseline in the Actual Hours of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline was calculated by subtracting the Baseline value (actual hours of awake time spent "off") from the week 17, 21, 25, 37, 49 and 52 value (proportion of awake time spent "off"). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline.The analyses for long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Change From Baseline in the Percentage of Awake Time Spent "Off" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Percentage of awake time spent "off" is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "off") from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "off"). Baseline is defined as the value at Week 13, If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Change From Baseline in Actual Hours of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On"(actual hours) is calculated as awake time spent "On" (hours) at the week 17, 21, 25, 37, 49 and 52 value minus awake time spent "On" (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Change From Baseline in Actual Hours of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "on " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On" without troublesome dyskinesias (actual hours) is calculated as \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at visit minus \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Change From Baseline in Percentage of Awake Time Spent "On" at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "on " periods and asleep in diary cards every day. Percentage of awake time spent "on" is defined as sum of two days on time (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "on") from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "on"). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
Change From Baseline in Percentage of Awake Time Spent "On" Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Par. were asked to record the duration of their "on " periods and asleep in diary cards every day. Percentage of awake time spent "On" without troublesome dyskinesias is defined as sum of two days on time without troublesome dyskinesias \["On" time minus "On" time with troublesome dyskinesias\] (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "On" without troublesome dyskinesias) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "On" without troublesome dyskinesias). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.
Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52
A total of 81 participants (par.) were randomized, of which 71 participants completed the Dose Increase Effect Verification (DIEV) Phase and 62 participants entered the Long-term Phase and 39 participants completing the Long-term Phase.
| Milestone | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Started | 61 | 20 |
| Completed | 52 | 19 |
| Not completed | 9 | 1 |
| Withdrew: Adverse event | 5 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
| Milestone | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Started | 44 | 18 |
| Completed | 25 | 14 |
| Not completed | 19 | 4 |
| Withdrew: Adverse event | 5 | 1 |
| Withdrew: Physician decision | 3 | 0 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Protocol-defined stopping criteria | 1 | 0 |
| Withdrew: Study closed/terminated | 5 | 3 |
The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
| Scores on a scale | Ropinirole CR - High Dose Group |
|---|---|
| Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group | -4.8 ± 5.95 |
The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
| Scores on a scale | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2 | -2.9 ± 4.41 | -2.7 ± 4.27 |
| Week 4 | -3.8 ± 5.23 | -4.4 ± 3.50 |
| Week 6 | -4.6 ± 5.28 | -5.0 ± 5.09 |
| Week 8 | -5.2 ± 5.46 | -4.5 ± 4.94 |
| Week 12 | -4.8 ± 5.95 | -5.7 ± 5.18 |
The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
| Participants | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2, 30% or greater reduction from Baseline | 10 | 4 |
| Week 4, 30% or greater reduction from Baseline | 17 | 5 |
| Week 6, 30% or greater reduction from Baseline | 21 | 6 |
| Week 8, 30% or greater reduction from Baseline | 30 | 7 |
| Week 12, 30% or greater reduction from Baseline | 27 | 7 |
| Week 2, 20% or greater reduction from Baseline | 16 | 5 |
| Week 4, 20% or greater reduction from Baseline | 26 | 11 |
| Week 6, 20% or greater reduction from Baseline | 30 | 10 |
| Week 8, 20% or greater reduction from Baseline | 35 | 11 |
| Week 12, 20% or greater reduction from Baseline | 31 | 13 |
The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at the planned visit.
| Scores on a scale | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2 | -0.0 ± 0.50 | -0.1 ± 0.31 |
| Week 4 | -0.1 ± 0.57 | -0.2 ± 0.49 |
| Week 6 | -0.1 ± 0.69 | -0.1 ± 0.45 |
| Week 8 | -0.1 ± 0.68 | -0.1 ± 0.45 |
| Week 12 | 0.1 ± 0.89 | -0.1 ± 0.45 |
The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
| Scores on a scale | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2, On status, n=61, 20 | -1.0 ± 2.00 | -0.2 ± 0.99 |
| Week 4, On status, n=61, 20 | -1.4 ± 2.60 | -0.3 ± 1.63 |
| Week 6, On status, n=61, 20 | -1.6 ± 3.03 | -0.5 ± 2.04 |
| Week 8, On status, n=61, 20 | -1.4 ± 3.23 | -0.2 ± 2.23 |
| Week 12, On status, n=61, 20 | -1.1 ± 3.61 | -0.2 ± 2.64 |
| Week 2, Off status, n=53, 18 | -1.0 ± 2.13 | -0.3 ± 1.97 |
| Week 4, Off status, n=53, 18 | -1.3 ± 3.23 | -0.4 ± 2.89 |
| Week 6, Off status, n=53, 18 | -1.7 ± 3.90 | -0.8 ± 2.26 |
| Week 8, Off status, n=53, 18 | -1.4 ± 3.92 | -1.3 ± 2.27 |
| Week 12, Off status, n=53, 18 | -1.4 ± 4.25 | -1.3 ± 2.52 |
The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
| Scores on a scale | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2 | -0.3 ± 1.10 | -0.2 ± 1.01 |
| Week 4 | -0.2 ± 1.24 | -0.2 ± 1.39 |
| Week 6 | -0.2 ± 1.43 | -0.3 ± 1.49 |
| Week 8 | 0.0 ± 1.32 | 0.1 ± 1.28 |
| Week 12 | -0.1 ± 1.38 | 0.1 ± 1.29 |
The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
| Percent change | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2 | -6.2 ± 40.06 | -16.7 ± 35.63 |
| Week 4 | -14.5 ± 63.87 | -41.7 ± 49.60 |
| Week 6 | -15.2 ± 83.82 | -29.2 ± 45.21 |
| Week 8 | -16.4 ± 82.27 | -29.2 ± 45.21 |
| Week 12 | -7.4 ± 85.84 | -29.2 ± 45.21 |
The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
| Percent change | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2, On status, n=55, 16 | -22.3 ± 35.46 | -4.6 ± 20.29 |
| Week 4, On status, n=55, 16 | -21.9 ± 43.38 | -13.0 ± 39.07 |
| Week 6, On status, n=55, 16 | -21.4 ± 48.64 | -12.9 ± 53.71 |
| Week 8, On status, n=55, 16 | -14.3 ± 75.53 | -9.0 ± 59.34 |
| Week 12, On status, n=55, 16 | -4.7 ± 102.75 | -9.3 ± 63.12 |
| Week 2, Off status, n=48, 15 | -11.7 ± 26.38 | -4.2 ± 13.45 |
| Week 4, Off status, n=48, 15 | -15.0 ± 36.35 | -4.4 ± 18.18 |
| Week 6, Off status, n=48, 15 | -17.0 ± 42.27 | -9.7 ± 17.69 |
| Week 8, Off status, n=48, 15 | -14.7 ± 40.53 | -10.9 ± 16.68 |
| Week 12, Off status, n=48, 15 | -15.2 ± 44.90 | -10.1 ± 14.02 |
The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
| Percent change | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2 | -12.0 ± 18.69 | -11.8 ± 22.78 |
| Week 4 | -17.4 ± 23.29 | -21.9 ± 18.81 |
| Week 6 | -21.6 ± 23.96 | -22.9 ± 23.74 |
| Week 8 | -25.5 ± 26.97 | -22.9 ± 25.02 |
| Week 12 | -23.1 ± 29.88 | -27.6 ± 28.37 |
The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
| Percent change | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2 | -7.9 ± 36.71 | -1.9 ± 31.59 |
| Week 4 | -4.1 ± 41.73 | -6.5 ± 35.97 |
| Week 6 | -7.2 ± 47.39 | -4.9 ± 36.92 |
| Week 8 | 1.4 ± 46.48 | 3.5 ± 35.18 |
| Week 12 | -6.6 ± 46.04 | 9.5 ± 30.44 |
The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. Full Analysis Set 2 (FAS2) Population comprised of all participants in the FAS1 and shifted to Long-term Phase, excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.
| Scores on a scale | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Group: Long Term Phase |
|---|---|---|
| Week 17; n=42,17 | 0.1 ± 0.45 | 0.1 ± 0.56 |
| Week 21; n=40, 16 | 0.2 ± 0.88 | -0.2 ± 0.66 |
| Week 25; n=40, 17 | 0.2 ± 0.86 | -0.1 ± 0.83 |
| Week 37; n=33, 17 | 0.2 ± 1.02 | 0.1 ± 0.90 |
| Week 49; n=26, 14 | 0.2 ± 0.51 | 0.1 ± 0.73 |
| Week 52; n=25, 14 | 0.2 ± 0.58 | 0.2 ± 0.97 |
The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data."Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
| Scores on a scale | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Group: Long Term Phase |
|---|---|---|
| Week 17, On status, n=42, 17 | -0.1 ± 1.52 | 0.1 ± 0.60 |
| Week 21, On status, n=40, 16 | -0.4 ± 1.60 | 0.0 ± 0.89 |
| Week 25, On status, n=40, 17 | -0.2 ± 1.91 | -0.1 ± 0.99 |
| Week 37, On status, n=33, 17 | 0.0 ± 2.32 | 0.2 ± 1.48 |
| Week 49, On status, n=26, 14 | 0.0 ± 2.41 | 0.6 ± 1.70 |
| Week 52, On status, n=25, 14 | -0.2 ± 2.67 | 0.1 ± 1.35 |
| Week 17, Off status, n=36, 15 | -0.4 ± 2.33 | -0.5 ± 1.46 |
| Week 21, Off status, n=34, 14 | -0.4 ± 2.32 | -0.7 ± 1.07 |
| Week 25, Off status, n=34, 15 | -0.2 ± 2.27 | -1.5 ± 3.14 |
| Week 37, Off status, n=29, 15 | 0.9 ± 3.77 | 0.0 ± 5.01 |
| Week 49, Off status, n=24, 12 | 0.4 ± 3.11 | 0.8 ± 4.84 |
| Week 52, Off status, n=23, 12 | 0.4 ± 2.52 | 0.8 ± 4.32 |
The Japanese UPDRS assesses the status of PD participants objectively. Part 3 evaluates motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
| Scores on a scale | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Group: Long Term Phase |
|---|---|---|
| Week 17; n=41, 16 | -1.2 ± 3.46 | -0.7 ± 5.03 |
| Week 21, n=39, 16 | -2.5 ± 5.53 | -1.9 ± 4.92 |
| Week 25, n=40, 17 | -2.1 ± 5.09 | -0.6 ± 4.31 |
| Week 37; n=33, 17 | -1.9 ± 6.46 | 1.4 ± 7.65 |
| Week 49; n=26, 14 | -2.2 ± 8.66 | 0.6 ± 7.38 |
| Week 52; n=25, 14 | -1.9 ± 6.92 | -0.6 ± 5.49 |
The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
| Scores on a scale | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Group: Long Term Phase |
|---|---|---|
| Week 17, n=42, 17 | 0.1 ± 0.97 | -0.1 ± 1.03 |
| Week 21, n=40, 16 | 0.3 ± 1.01 | -0.1 ± 0.89 |
| Week 25, n=40, 17 | 0.4 ± 0.83 | 0.2 ± 2.24 |
| Week 37; n=33;17 | 0.5 ± 1.15 | 1.1 ± 2.80 |
| Week 49; n=26,14 | 0.9 ± 1.28 | 1.2 ± 2.72 |
| Week 52; n=25, 14 | 0.6 ± 1.04 | 0.8 ± 2.36 |
The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
| Percent change | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Group: Long Term Phase |
|---|---|---|
| Week 17, n=15, 7 | 13.3 ± 36.43 | -9.5 ± 71.27 |
| Week 21, n=14, 7 | -7.1 ± 28.47 | -31.0 ± 53.08 |
| Week 25, n=14, 7 | 3.6 ± 48.89 | -26.2 ± 60.75 |
| Week 37; n=9, 7 | 0.0 ± 43.30 | -11.9 ± 77.41 |
| Week 49; n=6, 5 | 20.8 ± 40.05 | 15.0 ± 85.88 |
| Week 52; n=6, 5 | 12.5 ± 44.02 | 5.0 ± 75.83 |
The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data."Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
| Percent change | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Group: Long Term Phase |
|---|---|---|
| Week 17, On status, n=35, 12 | 2.3 ± 62.37 | -5.8 ± 30.29 |
| Week 21, On status, n=33, 11 | -0.1 ± 62.87 | -7.1 ± 36.34 |
| Week 25, On status, n=33, 12 | -1.7 ± 41.50 | -0.7 ± 46.77 |
| Week 37, On status, n=26, 12 | 8.0 ± 64.38 | -8.6 ± 34.96 |
| Week 49, On status, n=20, 9 | 27.8 ± 99.17 | 1.8 ± 54.21 |
| Week 52, On status, n=19, 9 | 7.5 ± 93.46 | 0.7 ± 54.13 |
| Week 17, Off status, n=26, 13 | -1.4 ± 29.10 | -3.6 ± 14.44 |
| Week 21, Off status, n=24, 12 | -4.4 ± 35.76 | -6.0 ± 9.09 |
| Week 25, Off status, n=24, 13 | 1.4 ± 41.65 | -5.2 ± 38.30 |
| Week 37, Off status, n=20, 13 | 6.1 ± 54.09 | 6.3 ± 50.27 |
| Week 49, Off status, n=16, 11 | 1.9 ± 41.71 | 44.5 ± 96.82 |
| Week 52, Off status, n=15, 11 | 7.1 ± 39.24 | 26.2 ± 50.57 |
The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
| Percent change | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Group: Long Term Phase |
|---|---|---|
| Week 17, n=41, 16 | -5.4 ± 20.98 | 6.2 ± 38.25 |
| Week 21, n=39, 16 | -10.5 ± 25.83 | -6.0 ± 35.72 |
| Week 25, n=40, 17 | -10.3 ± 31.99 | 2.6 ± 36.71 |
| Week 37; n=33, 17 | -6.4 ± 30.91 | 50.2 ± 148.56 |
| Week 49; n=26, 14 | -3.4 ± 46.73 | 43.2 ± 134.85 |
| Week 52; n=25, 14 | -4.1 ± 44.35 | 16.2 ± 77.23 |
The Japanese UPDRS assesses the status of PD participants objectively. Part 4 evaluates complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
| Percent change | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Dose Group: Long Term Phase |
|---|---|---|
| Week 17, n=30, 15 | 13.1 ± 49.42 | 7.1 ± 43.29 |
| Week 21, n=28, 14 | 11.3 ± 48.62 | 6.8 ± 41.68 |
| Week 25, n=28, 15 | 16.4 ± 41.65 | 18.7 ± 101.42 |
| Week 37, n=23, 15 | 11.3 ± 38.32 | 49.5 ± 139.78 |
| Week 49, n=18, 13 | 27.5 ± 34.93 | 40.0 ± 123.78 |
| Week 52, n=17, 13 | 23.7 ± 36.32 | 35.4 ± 104.67 |
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "Off"(actual hours) is calculated as awake time spent "Off" (hours) at the indicated visit minus awake time spent "Off" (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
| hours | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2 | 0.14 ± 2.260 | 0.44 ± 1.605 |
| Week 4 | 0.09 ± 2.308 | 0.04 ± 1.817 |
| Week 6 | 0.01 ± 2.645 | 0.37 ± 2.068 |
| Week 8 | -0.08 ± 2.552 | 0.77 ± 2.442 |
| Week 12 | -0.27 ± 2.781 | 0.81 ± 1.953 |
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Percentage of awake time spent "off" is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "off") from the post Baseline value (percentage of awake time spent "off"). Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
| percentage of awake time spent off | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2 | 1.36 ± 13.025 | 2.39 ± 9.119 |
| Week 4 | 0.62 ± 13.486 | 0.48 ± 10.116 |
| Week 6 | -0.09 ± 15.677 | 2.70 ± 10.518 |
| Week 8 | 0.19 ± 16.012 | 4.65 ± 12.040 |
| Week 12 | -1.24 ± 16.814 | 4.74 ± 11.214 |
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On"(actual hours) is calculated as awake time spent "On" (hours) at the indicated visit minus awake time spent "On" (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
| hours | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2, n=53, 17 | -0.39 ± 2.154 | -0.46 ± 1.635 |
| Week 4, n=53, 18 | -0.12 ± 2.271 | -0.60 ± 2.180 |
| Week 6, n=53, 18 | -0.01 ± 2.474 | -0.61 ± 1.676 |
| Week 8, n=53, 18 | -0.11 ± 2.759 | -0.96 ± 1.554 |
| Week 12, n=53, 18 | 0.07 ± 2.789 | -0.79 ± 1.815 |
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On" without troublesome dyskinesias (actual hours) is calculated as \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at visit minus \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
| hours | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Week 2, n=53, 17 | -0.40 ± 2.276 | -0.59 ± 1.400 |
| Week 4, n=53, 18 | -0.14 ± 2.359 | -0.71 ± 1.745 |
| Week 6, n=53, 18 | -0.06 ± 2.566 | -0.63 ± 1.476 |
| Week 8, n=53, 18 | -0.05 ± 2.896 | -1.01 ± 1.549 |
| Week 12, n=53, 18 | 0.11 ± 2.968 | -0.74 ± 1.733 |
The CGI global improvement scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of \<=2 (representing much improved or very much improved) were considered to be moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
| Participants | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12 | 19 | 6 |
| Participants | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group |
|---|---|---|
| Number of Participants Remaining in the Study | 25 | 14 |
The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 17, 21, 25, 37, 49 and 52,are presented using OC data. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.
| Participants | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Group: Long Term Phase |
|---|---|---|
| Week 17, >=30% reduction from Baseline; n=41,16 | 5 | 2 |
| Week 21, >=30% reduction from Baseline; n=39,16 | 8 | 3 |
| Week 25, >=30% reduction from Baseline; n=40, 17 | 9 | 3 |
| Week 37, >=30% reduction from Baseline; n=33,17 | 8 | 3 |
| Week 49, >=30% reduction from Baseline; n=26, 14 | 9 | 1 |
| Week 52, >=30% reduction from Baseline; n=25, 14 | 6 | 2 |
| Week 17, >=20% reduction from Baseline; n=41,16 | 8 | 2 |
| Week 21, >=20% reduction from Baseline; n=39,16 | 15 | 3 |
| Week 25, >=20% reduction from Baseline; n=40, 17 | 16 | 3 |
| Week 37, >=20% reduction from Baseline; n=33,17 | 14 | 3 |
| Week 49, >=20% reduction from Baseline; n=26, 14 | 13 | 3 |
| Week 52, >=20% reduction from Baseline; n=25, 14 | 12 | 4 |
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline was calculated by subtracting the Baseline value (actual hours of awake time spent "off") from the week 17, 21, 25, 37, 49 and 52 value (proportion of awake time spent "off"). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline.The analyses for long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data
| hours | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Dose Group: Long Term Phase |
|---|---|---|
| Week 17, n=26, 13 | -0.63 ± 2.600 | -0.50 ± 1.829 |
| Week 21, n=24, 12 | -0.40 ± 1.892 | -0.65 ± 1.428 |
| Week 25, n=24, 13 | 0.04 ± 1.442 | -0.52 ± 1.325 |
| Week 37, n=20, 13 | 0.01 ± 2.999 | -0.46 ± 2.252 |
| Week 49, n=18, 11 | -0.24 ± 1.945 | 0.91 ± 3.117 |
| Week 52, n=15, 11 | -0.62 ± 1.797 | 0.45 ± 2.255 |
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Percentage of awake time spent "off" is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "off") from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "off"). Baseline is defined as the value at Week 13, If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.
| percentage of awake time spent off | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Dose Group: Long Term Phase |
|---|---|---|
| Week 17, n=26, 13 | -4.16 ± 15.734 | -4.41 ± 16.606 |
| Week 21, n=24, 12 | -2.59 ± 10.682 | -5.39 ± 13.102 |
| Week 25, n=24, 13 | 0.49 ± 8.123 | -3.95 ± 10.677 |
| Week 37, n=20, 13 | -0.99 ± 15.204 | -4.56 ± 20.134 |
| Week 49, n=18, 11 | -1.33 ± 11.509 | 2.93 ± 19.464 |
| Week 52, n=15, 11 | -3.62 ± 9.925 | 1.24 ± 13.957 |
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "off " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On"(actual hours) is calculated as awake time spent "On" (hours) at the week 17, 21, 25, 37, 49 and 52 value minus awake time spent "On" (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.
| hours | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Dose Group: Long Term Phase |
|---|---|---|
| Week 17, n=36, 15 | 0.56 ± 2.472 | 0.57 ± 2.376 |
| Week 21, n=34, 14 | 0.43 ± 1.585 | 0.73 ± 2.006 |
| Week 25, n=34, 15 | -0.04 ± 1.434 | 0.23 ± 1.896 |
| Week 37, n=29, 15 | 0.26 ± 2.188 | 0.37 ± 3.266 |
| Week 49, n=26, 12 | -0.19 ± 1.764 | -0.56 ± 3.163 |
| Week 52, n=23, 12 | 0.36 ± 1.539 | -0.56 ± 2.358 |
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "on " periods and asleep in diary cards every day. Change from Baseline in awake time spent "On" without troublesome dyskinesias (actual hours) is calculated as \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at visit minus \[awake time spent "On" minus awake time spent "On" with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data
| hours | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Dose Group: Long Term Phase |
|---|---|---|
| Week 17, n=36, 15 | 0.24 ± 2.245 | 0.60 ± 2.347 |
| Week 21, n=34, 14 | 0.21 ± 1.850 | 1.23 ± 2.403 |
| Week 25, n=34, 15 | -0.15 ± 1.341 | 0.25 ± 2.615 |
| Week 37, n=29, 15 | -0.09 ± 2.247 | 1.02 ± 3.447 |
| Week 49, n=26, 12 | -0.50 ± 1.877 | 0.04 ± 2.720 |
| Week 52, n=23, 12 | 0.08 ± 1.378 | -0.21 ± 2.886 |
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their "on " periods and asleep in diary cards every day. Percentage of awake time spent "on" is defined as sum of two days on time (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "on") from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "on"). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.
| percentage of awake time spent on | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Dose Group: Long Term Phase |
|---|---|---|
| Week 17, n=36, 15 | 2.81 ± 13.529 | 3.82 ± 15.452 |
| Week 21, n=34, 14 | 1.20 ± 9.841 | 4.62 ± 12.211 |
| Week 25, n=34, 15 | -1.02 ± 7.813 | 3.42 ± 9.982 |
| Week 37, n=29, 15 | 0.13 ± 12.766 | 3.27 ± 19.048 |
| Week 49, n=26, 12 | -0.23 ± 10.389 | -2.68 ± 18.578 |
| Week 52, n=23, 12 | 1.80 ± 8.706 | -1.14 ± 13.313 |
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Par. were asked to record the duration of their "on " periods and asleep in diary cards every day. Percentage of awake time spent "On" without troublesome dyskinesias is defined as sum of two days on time without troublesome dyskinesias \["On" time minus "On" time with troublesome dyskinesias\] (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent "On" without troublesome dyskinesias) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent "On" without troublesome dyskinesias). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.
| percentage of awake time spent on | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Dose Group: Long Term Phase |
|---|---|---|
| Week 17, n=36, 15 | 0.70 ± 11.655 | 4.04 ± 15.472 |
| Week 21, n=34, 14 | -0.16 ± 11.730 | 7.31 ± 13.780 |
| Week 25, n=34, 15 | -1.70 ± 7.765 | 3.10 ± 15.036 |
| Week 37, n=29, 15 | -1.71 ± 13.698 | 6.93 ± 19.472 |
| Week 49, n=26, 12 | -2.00 ± 11.835 | 0.45 ± 15.958 |
| Week 52, n=23, 12 | -0.05 ± 7.521 | 0.53 ± 14.966 |
Collected over Serious adverse events (SAEs) and non-SAEs were collected from the start of study treatment (Week 0) until Week 52.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ropinirole CR - High Dose Group | — | 2/61 (3.3%) | 13/61 (21.3%) |
| Ropinirole CR - Maintenance Group | — | 4/20 (20%) | 11/20 (55%) |
| Ropinirole CR - High Dose Group: Long Term Phase | — | 0/44 (0%) | 14/44 (31.8%) |
| Ropinirole CR - Maintenance Group: Long Term Phase | — | 1/18 (5.6%) | 13/18 (72.2%) |
| Event | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Group | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Group: Long Term Phase |
|---|---|---|---|---|
| Uterine prolapseReproductive system and breast disorders | 0/61 | 1/20 | 0/44 | 1/18 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/61 | 0/20 | 0/44 | 1/18 |
| Atrial fibrillationCardiac disorders | 0/61 | 1/20 | 0/44 | 0/18 |
| Inguinal herniaGastrointestinal disorders | 0/61 | 1/20 | 0/44 | 0/18 |
| Fractured sacrumInjury, poisoning and procedural complications | 0/61 | 1/20 | 0/44 | 0/18 |
| Cerebral infarctionNervous system disorders | 0/61 | 1/20 | 0/44 | 0/18 |
| Myocardial infarctionCardiac disorders | 1/61 | 0/20 | 0/44 | 0/18 |
| PericarditisCardiac disorders | 1/61 | 0/20 | 0/44 | 0/18 |
| Ovarian cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/61 | 0/20 | 0/44 | 0/18 |
| Event | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Group | Ropinirole CR - High Dose Group: Long Term Phase | Ropinirole CR - Maintenance Group: Long Term Phase |
|---|---|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 0/61 | 0/20 | 0/44 | 4/18 |
| NasopharyngitisInfections and infestations | 2/61 | 4/20 | 5/44 | 0/18 |
| Sudden onset of sleepNervous system disorders | 2/61 | 2/20 | 1/44 | 3/18 |
| VomitingGastrointestinal disorders | 0/61 | 1/20 | 0/44 | 2/18 |
| ConstipationGastrointestinal disorders | 0/61 | 0/20 | 3/44 | 2/18 |
| NauseaGastrointestinal disorders | 3/61 | 1/20 | 0/44 | 2/18 |
| DyskinesiaNervous system disorders | 3/61 | 2/20 | 2/44 | 1/18 |
| EczemaSkin and subcutaneous tissue disorders | 0/61 | 0/20 | 3/44 | 0/18 |
| SomnolenceNervous system disorders | 4/61 | 1/20 | 0/44 | 0/18 |
| DizzinessNervous system disorders | 0/61 | 0/20 | 1/44 | 1/18 |
| Age, Continuous(Years) | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group | Total |
|---|---|---|---|
| Mean | 65.5 ± 8.95 | 63.3 ± 12.42 | 65.0 ± 9.88 |
| Sex: Female, Male(Participants) | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group | Total |
|---|---|---|---|
| Female | 39 | 11 | 50 |
| Male | 22 | 9 | 31 |
| Race/Ethnicity, Customized(Participants) | Ropinirole CR - High Dose Group | Ropinirole CR - Maintenance Dose Group | Total |
|---|---|---|---|
| Japanese/East Asian Heritage (EAH)/South EAH | 61 | 20 | 81 |
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