A Phase 3 interventional study of Ropinirole IR 1 mg and Ropinirole IR 2 mg in Restless Legs Syndrome and Restless Legs Syndrome (RLS), sponsored by GlaxoSmithKline. Completed at 30 sites in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2019-03-15.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
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Exclusion Criteria:
Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.
Drug: Ropinirole IR 1 mg · Drug: Ropinirole IR 1 mg Placebo · Drug: Ropinirole CR 2 mg · Drug: Ropinirole CR 2 mg Placebo
Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Drug: Ropinirole IR 1 mg · Drug: Ropinirole IR 1 mg Placebo · Drug: Ropinirole CR 2 mg · Drug: Ropinirole CR 2 mg Placebo
Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.
Drug: Ropinirole IR 2 mg · Drug: Ropinirole IR 2 mg Placebo · Drug: Ropinirole CR 3 mg · Drug: Ropinirole CR 3 mg Placebo
Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Drug: Ropinirole IR 2 mg · Drug: Ropinirole IR 2 mg Placebo · Drug: Ropinirole CR 3 mg · Drug: Ropinirole CR 3 mg Placebo
Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.
Drug: Ropinirole IR 2 mg · Drug: Ropinirole IR 2 mg Placebo · Drug: Ropinirole CR 3 mg · Drug: Ropinirole CR 3 mg Placebo
Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Drug: Ropinirole IR 2 mg · Drug: Ropinirole IR 2 mg Placebo · Drug: Ropinirole CR 3 mg · Drug: Ropinirole CR 3 mg Placebo
Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.
Also known as: ropinirole controlled-release for RLS
Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.
Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.
Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.
Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.
Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.
Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.
Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.
Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period
AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 1 period and during the post-conversion 1 period. The second conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 2 period and during the post-conversion 2 period.
Time frame: Up to 5 weeks
Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS
AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Onset of an AE was pre-Conversion 1 and discontinuation for the same AE occurred post-Conversion 1. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.
Time frame: Up to 5 weeks
Number of Participants With SAEs and Severity of AEs
SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Severity was measured in terms of grades mild, moderate, and severe. SAEs data only for post-conversion has been reported.
Time frame: Up to 5 weeks
Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion
Global Improvement Scale (CGI-I) allows the Investigator to rate the participants' global improvement or worsening compared with the condition at Baseline (Day 0), whether or not the change is thought to be due to treatment with study drug. The scale is rated from 1 to 7 (1="Very much improved" to 7="Very much worse"). Typically, a participant with a score of 1 were considered as "Very much improved" and 2 as "Much improved" responder. Positive response was given in terms of worsen to stable or stable to improved.
Time frame: Up to 4 weeks
Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion
The IRLS Rating Scale was developed to measure disease severity for clinical assessment, research, and therapeutic studies an also to show relationship between responses and overall RLS severity. The IRLS Rating Scale is a disease-specific 10-item scale that is based on the IRLSSG consensus of clinical features and associated sleep problems. The investigator asked the participant to rate his/her symptoms for each of the ten questions contained in the IRLS Rating Scale from 0 to 4, with 0 representing the absence of a problem and 4 a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. Changes from pre- to one-week post-conversion in the IRLS rating scale total score was obtained by subtracting the "Week 1" total score from the "Week 2" total score for the first conversion and the "Week 3" total score from the "Week 4" total score for the second conversion.
Time frame: Up to 5 weeks
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC)
The number of participants with pre- and post- conversion orthostatic systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values of PCC were summarized. Both conversions (drug and dummy) were considered. High and low values of only orthostatic SBP and DBP of PCC are presented.
Time frame: Up to 5 weeks
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion
Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic SBP and DBP of PCC are presented. Change from pre-conversion in BP is the value of BP at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in blood pressure. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as "Week 2" values minus the Week 1" values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the "Week 4" values minus the Week 3" values.
Time frame: Up to 5 weeks
Change From Pre-conversion in Pulse Rate to One Week Post-conversion
Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic pulse of PCC are presented. Change from pre-conversion in pulse rate is the value of pulse rate at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in pulse. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as "Week 2" values minus the "Week 1" values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the "Week 4" values minus the "Week 3" values.
Time frame: Up to 5 weeks
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure
Blood pressure (both systolic and diastolic) measurements were made just prior to the first dose of study medication ('evening' dose, ropinirole CR-RLS or matching placebo) and then every hour afterwards up to bedtime (when the device was removed). The changes for the first conversion were calculated as the "post evening dose" values minus the "pre evening dose" values at the Week 1 visit and the changes for the second conversion were the "post evening dose" values minus the "pre evening dose" values at the Week 3 visit.
Time frame: Up to 5 weeks
This study was conducted from 14 November 2005 till 21 September 2006 across 27 centers in the United States (US).
| Milestone | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS |
|---|---|---|---|---|---|---|
| Started | 26 | 26 | 26 | 27 | 16 | 14 |
| Completed | 23 | 22 | 23 | 24 | 15 | 13 |
| Not completed | 3 | 4 | 3 | 3 | 1 | 1 |
| Withdrew: Withdrawal by subject | 2 | 3 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 1 | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 2 | 2 | 0 | 1 |
| Withdrew: Not compliant with the study drug | 0 | 0 | 0 | 0 | 1 | 0 |
AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 1 period and during the post-conversion 1 period. The second conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 2 period and during the post-conversion 2 period.
| Participants | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS |
|---|---|---|---|---|---|---|
| Post-conversion 1 | 9 | 14 | 10 | 11 | 7 | 5 |
| Post-conversion 2 | 6 | 8 | 7 | 6 | 5 | 6 |
AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Onset of an AE was pre-Conversion 1 and discontinuation for the same AE occurred post-Conversion 1. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.
| Participants | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS |
|---|---|---|---|---|---|---|
| Post-conversion 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Post-conversion 2 | 0 | 0 | 0 | 0 | 0 | 0 |
SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Severity was measured in terms of grades mild, moderate, and severe. SAEs data only for post-conversion has been reported.
| Participants | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS |
|---|---|---|---|---|---|---|
| Any SAE, post conversion 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any SAE, post conversion 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Mild AE, post conversion 1 | 5 | 9 | 5 | 6 | 3 | 2 |
| Moderate AE, post conversion 1 | 4 | 7 | 4 | 6 | 4 | 4 |
| Severe AE, post conversion 1 | 2 | 5 | 6 | 2 | 2 | 1 |
| Mild AE, post conversion 2 | 3 | 2 | 1 | 1 | 2 | 1 |
| Moderate AE, post conversion 2 | 2 | 4 | 3 | 5 | 4 | 1 |
| Severe AE, post conversion 2 | 2 | 2 | 3 | 0 | 0 | 4 |
Global Improvement Scale (CGI-I) allows the Investigator to rate the participants' global improvement or worsening compared with the condition at Baseline (Day 0), whether or not the change is thought to be due to treatment with study drug. The scale is rated from 1 to 7 (1="Very much improved" to 7="Very much worse"). Typically, a participant with a score of 1 were considered as "Very much improved" and 2 as "Much improved" responder. Positive response was given in terms of worsen to stable or stable to improved.
| Participants | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS |
|---|---|---|---|---|---|---|
| Post Coversion 1 | 14 | 12 | 10 | 9 | 6 | 6 |
| Post Conversion 2 | 11 | 14 | 13 | 14 | 5 | 7 |
The IRLS Rating Scale was developed to measure disease severity for clinical assessment, research, and therapeutic studies an also to show relationship between responses and overall RLS severity. The IRLS Rating Scale is a disease-specific 10-item scale that is based on the IRLSSG consensus of clinical features and associated sleep problems. The investigator asked the participant to rate his/her symptoms for each of the ten questions contained in the IRLS Rating Scale from 0 to 4, with 0 representing the absence of a problem and 4 a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. Changes from pre- to one-week post-conversion in the IRLS rating scale total score was obtained by subtracting the "Week 1" total score from the "Week 2" total score for the first conversion and the "Week 3" total score from the "Week 4" total score for the second conversion.
| Scores on a scale | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS |
|---|---|---|---|---|---|---|
| Post-Conversion 1 | -5.1 ± 8.84 | -0.1 ± 7.34 | -1.5 ± 6.73 | -1.3 ± 7.15 | -5.8 ± 6.14 | 1.2 ± 10.33 |
| Post-Conversion 2 | -2.9 ± 7.07 | -4.8 ± 7.73 | -1.6 ± 6.29 | -5.2 ± 9.62 | 0.6 ± 7.28 | -2.2 ± 11.58 |
The number of participants with pre- and post- conversion orthostatic systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values of PCC were summarized. Both conversions (drug and dummy) were considered. High and low values of only orthostatic SBP and DBP of PCC are presented.
| Participants | Ropinirole Cohort A | Ropinirole Cohort B | Ropinirole Cohort C |
|---|---|---|---|
| 1 mg IR to 2 mg CR, SBP, PCC low, pre-conversion | 1 | — | — |
| 1 mg IR to 1 mg IR, SBP, PCC high, post-conversion | 1 | — | — |
| 2 mg IR to 3 mg CR, SBP, PCC high, pre-conversion | — | 1 | — |
| 2 mg IR to 2 mg IR,SBP, PCC high, post-conversion | — | 1 | — |
| 4 mg IR to 4 mg IR, SBP, PCC high, pre-conversion | — | — | 1 |
| 1 mg IR to 2 mg CR, DBP, PCC high, pre-conversion | 2 | — | — |
| 1 mg IR to 2 mg CR, DBP, PCC high, post-conversion | 3 | — | — |
| 1 mg IR to 1 mg IR, DBP, PCC high, pre-conversion | 4 | — | — |
| 1 mg IR to 1 mg IR, DBP, PCC high, post-conversion | 2 | — | — |
| 2 mg IR to 3 mg CR, DBP, PCC high, pre-conversion | — | 1 | — |
| 2 mg IR to 3 mg CR, DBP, PCC high, post-conversion | — | 6 | — |
| 2 mg IR to 2 mg IR, DBP, PCC high, pre-conversion | — | 2 | — |
| 2 mg IR to 2 mg IR, DBP, PCC high, post-conversion | — | 2 | — |
| 4 mg IR to 6 mg CR, DBP, PCC high, post-conversion | — | — | 4 |
| 4 mg IR to 4 mg IR, DBP, PCC high, pre-conversion | — | — | 1 |
| 4 mg IR to 4 mg IR, DBP, PCC high, post-conversion | — | — | 2 |
| 1 mg IR to 1 mg IR, pulse, PCC low,post-conversion | 1 | — | — |
| 2 mg IR to 3 mg CR, pulse, PCC high,pre-conversion | — | 1 | — |
| 2 mg IR to 2 mg IR, pulse,PCC high,post-conversion | — | 2 | — |
Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic SBP and DBP of PCC are presented. Change from pre-conversion in BP is the value of BP at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in blood pressure. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as "Week 2" values minus the Week 1" values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the "Week 4" values minus the Week 3" values.
| Millimeters of mercury (mm of Hg) | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS |
|---|---|---|---|---|---|---|
| Semi-supine SBP, conversion 1 | -0.8 ± 12.08 | -3.9 ± 13.78 | 4.0 ± 10.81 | -7.7 ± 10.20 | -1.2 ± 7.85 | -5.3 ± 17.84 |
| Standing SBP, conversion 1 | 2.3 ± 12.57 | -2.9 ± 13.18 | -0.2 ± 14.19 | -4.1 ± 10.75 | 0.7 ± 6.64 | -3.9 ± 11.43 |
| Semi-supine SBP, conversion 2 | 1.6 ± 14.51 | 0.6 ± 10.33 | 0.3 ± 8.91 | 2.1 ± 10.73 | -2.6 ± 8.81 | -6.2 ± 19.61 |
| Standing SBP, conversion 2 | -0.3 ± 13.24 | 3.1 ± 14.59 | 3.6 ± 9.23 | 1.0 ± 12.90 | 0.4 ± 12.42 | -4.9 ± 16.82 |
| Orhostatic SBP, post-conversion 1 | 3.2 ± 10.69 | 1.0 ± 10.29 | -4.2 ± 12.12 | 3.4 ± 9.95 | 1.9 ± 7.76 | 1.4 ± 9.69 |
| Orthostatic SBP, post-conversion 2 | -1.9 ± 10.18 | 2.5 ± 13.32 | 3.3 ± 8.42 | -1.0 ± 9.73 | 3.0 ± 13.46 | 1.3 ± 12.39 |
| Semi-supine DBP, conversion 1 | 1.3 ± 10.96 | -2.5 ± 8.10 | 2.2 ± 10.43 | -3.5 ± 6.52 | -1.3 ± 7.61 | -1.2 ± 6.91 |
| Standing DBP, conversion 1 | 3.3 ± 7.56 | -3.4 ± 10.25 | 4.1 ± 11.45 | -3.2 ± 7.11 | 0.6 ± 6.07 | -0.8 ± 10.08 |
| Semi-supine DBP, conversion 2 | -0.5 ± 8.67 | 2.8 ± 8.80 | 1.3 ± 5.53 | -0.7 ± 8.17 | 0.0 ± 5.45 | -0.7 ± 13.24 |
| Standing DBP, conversion 2 | -2.7 ± 8.64 | 2.8 ± 7.92 | 0.3 ± 7.42 | 0.7 ± 8.91 | -0.3 ± 6.76 | 1.8 ± 12.14 |
| Orthostatic DBP, post-conversion 1 | 2.0 ± 7.22 | -0.9 ± 7.11 | 1.9 ± 9.70 | 0.5 ± 6.37 | 1.9 ± 6.53 | 0.4 ± 8.17 |
| Orthostatic DBP, post-conversion 2 | -2.2 ± 5.69 | 0.0 ± 6.30 | -1.1 ± 6.49 | 1.4 ± 7.82 | -0.3 ± 3.31 | 2.5 ± 8.37 |
Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic pulse of PCC are presented. Change from pre-conversion in pulse rate is the value of pulse rate at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in pulse. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as "Week 2" values minus the "Week 1" values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the "Week 4" values minus the "Week 3" values.
| Beats per minute (bpm) | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS |
|---|---|---|---|---|---|---|
| Semi-supine pulse, Conversion 1 | -0.1 ± 7.01 | -0.4 ± 5.38 | 1.0 ± 9.42 | -0.9 ± 6.81 | -1.5 ± 6.99 | 1.2 ± 8.09 |
| Standing pulse, Conversion 1 | 2.4 ± 8.39 | 0.3 ± 9.48 | 0.0 ± 10.71 | 0.7 ± 8.82 | -0.8 ± 7.84 | -0.8 ± 8.69 |
| Semi-supine pulse, Conversion 2 | -0.7 ± 8.11 | 0.3 ± 6.81 | 0.2 ± 9.05 | 0.3 ± 8.49 | 0.6 ± 5.18 | -0.8 ± 8.97 |
| Standing pulse, Conversion 2 | -0.4 ± 9.36 | 0.3 ± 8.95 | 1.4 ± 12.77 | 0.9 ± 9.01 | 0.9 ± 5.99 | 1.5 ± 8.53 |
| Post-Conversion 1 | 2.5 ± 8.80 | 0.7 ± 8.38 | -1.0 ± 6.72 | 1.6 ± 8.29 | 0.7 ± 4.59 | -2.0 ± 7.56 |
| Post-Conversion 2 | 0.3 ± 9.27 | 0.0 ± 6.78 | 1.2 ± 9.87 | 0.6 ± 6.24 | 0.3 ± 6.07 | 2.2 ± 5.37 |
Blood pressure (both systolic and diastolic) measurements were made just prior to the first dose of study medication ('evening' dose, ropinirole CR-RLS or matching placebo) and then every hour afterwards up to bedtime (when the device was removed). The changes for the first conversion were calculated as the "post evening dose" values minus the "pre evening dose" values at the Week 1 visit and the changes for the second conversion were the "post evening dose" values minus the "pre evening dose" values at the Week 3 visit.
| mmHg | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS |
|---|---|---|---|---|---|---|
| SBP, conversion 1, <30 minutes | -20.0 ± NA | — | -20.0 ± NA | -6.0 ± NA | — | — |
| SBP, conversion 1, 1 hour | -8.0 ± 10.64 | -6.4 ± 14.14 | -10.6 ± 9.86 | -1.0 ± 10.96 | -6.3 ± 8.35 | -5.0 ± 2.83 |
| SBP, conversion 1, 2 hours | -12.9 ± 14.10 | 0.1 ± 16.83 | -9.1 ± 6.84 | -4.3 ± 10.35 | -8.0 ± 7.19 | 7.5 ± 4.95 |
| SBP, conversion 1, 3 hours | -10.8 ± 13.57 | 1.3 ± 12.46 | -15.9 ± 13.71 | -3.0 ± 9.49 | -7.4 ± 8.82 | -4.5 ± 0.71 |
| SBP, conversion 1, 4 hours | -11.0 ± 7.26 | -9.9 ± 17.40 | -12.8 ± 15.82 | -10.3 ± 7.74 | -12.8 ± 12.89 | 3.5 ± 2.12 |
| SBP, conversion 1, 5 hours | -8.6 ± 7.70 | -10.6 ± 20.86 | -15.5 ± 13.77 | -8.3 ± 5.91 | -15.5 ± 6.36 | 14.0 ± NA |
| SBP, conversion 1, 6 hours | -14.3 ± 4.51 | -11.0 ± NA | -9.0 ± 21.38 | -11.0 ± 25.46 | — | 0.0 ± NA |
| SBP, conversion 2, <30 minutes | — | -15.0 ± NA | — | — | -5.5 ± 4.95 | 12.0 ± NA |
| SBP, conversion 2, 1 hour | -5.4 ± 11.35 | -1.5 ± 13.81 | -1.6 ± 9.80 | -1.3 ± 13.47 | 0.6 ± 10.71 | -2.8 ± 3.77 |
| SBP, conversion 2, 2 hours | 2.6 ± 19.23 | -10.6 ± 17.44 | 2.0 ± 6.62 | -0.6 ± 16.33 | -0.3 ± 6.56 | -5.0 ± 10.71 |
| SBP, conversion 2, 3 hours | -12.0 ± 13.51 | -4.6 ± 11.64 | -3.3 ± 12.01 | 0.7 ± 14.13 | -5.0 ± 9.49 | -4.3 ± 8.81 |
| SBP, conversion 2, 4 hours | 1.0 ± 10.61 | -6.8 ± 4.27 | -2.6 ± 14.04 | 6.4 ± 4.04 | 0.3 ± 13.41 | -7.3 ± 5.56 |
| SBP, conversion 2, 5 hours | -9.0 ± 7.07 | -11.0 ± 11.36 | -0.5 ± 13.10 | 3.7 ± 9.45 | -18.0 ± 8.54 | 9.0 ± NA |
| SBP, conversion 2, 6 hours | -8.0 ± NA | 3.0 ± NA | -0.6 ± 14.84 | -7.0 ± NA | -20.5 ± 7.78 | — |
| DBP, conversion 1, <30 minutes | -6.0 ± NA | — | -2.0 ± NA | -2.0 ± NA | — | — |
| DBP, conversion 1, 1 hour | -4.9 ± 6.69 | -4.7 ± 10.37 | -1.6 ± 9.46 | -1.5 ± 9.64 | -5.4 ± 8.55 | -5.0 ± 1.41 |
| DBP, conversion 1, 2 hours | -9.0 ± 13.59 | -2.9 ± 10.53 | -0.4 ± 7.32 | -4.8 ± 6.71 | -3.4 ± 7.25 | 6.0 ± 4.24 |
| DBP, conversion 1, 3 hours | -4.9 ± 10.89 | -1.9 ± 9.72 | -8.1 ± 11.26 | -9.2 ± 9.14 | -5.4 ± 7.96 | -5.0 ± 8.49 |
| DBP, conversion 1, 4 hours | -5.3 ± 6.82 | -9.7 ± 10.74 | -8.4 ± 8.41 | -5.1 ± 8.11 | -4.0 ± 10.89 | 4.0 ± 4.24 |
| DBP, conversion 1, 5 hours | -1.2 ± 2.28 | -8.4 ± 14.13 | -10.0 ± 9.42 | -5.8 ± 9.29 | -14.5 ± 9.19 | 0.0 ± 0.0 |
| DBP, conversion 1, 6 hours | -9.0 ± 4.36 | -23.0 ± NA | -3.3 ± 2.08 | -6.0 ± 9.90 | — | 8.0 ± NA |
| DBP, conversion 2, <30 minutes | — | -10.0 ± NA | — | — | -4.5 ± 0.71 | 20.0 ± NA |
| DBP, conversion 2, 1 hour | -0.4 ± 12.70 | -5.1 ± 10.37 | -1.9 ± 8.50 | 0.9 ± 12.86 | 0.2 ± 8.97 | 3.8 ± 7.69 |
| DBP, conversion 2, 2 hours | 4.6 ± 12.42 | -9.6 ± 11.90 | -3.3 ± 11.19 | 0.9 ± 15.45 | -4.4 ± 8.62 | -10.5 ± 9.15 |
| DBP, conversion 2, 3 hours | 2.4 ± 20.42 | -5.8 ± 7.12 | -10.5 ± 14.16 | -1.4 ± 10.67 | -7.2 ± 5.71 | -4.5 ± 7.59 |
| DBP, conversion 2, 4 hours | 0.8 ± 17.11 | -8.3 ± 10.14 | -4.6 ± 17.66 | -1.0 ± 10.51 | -3.8 ± 7.19 | -7.8 ± 7.97 |
| DBP, conversion 2, 5 hours | -8.0 ± 0.00 | -2.3 ± 13.61 | -7.5 ± 13.71 | 2.0 ± 16.09 | -17.0 ± 5.20 | 8.0 ± NA |
| DBP, conversion 2, 6 hours | -7.0 ± NA | -10.0 ± NA | -5.8 ± 20.03 | -15.0 ± NA | -15.0 ± 1.41 | — |
Collected over Up to 5 weeks. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ropinirole Cohort A | 0/52 (0%) | 1/52 (1.9%) | 37/52 (71.2%) |
| Ropinirole Cohort B | 0/53 (0%) | 0/53 (0%) | 38/53 (71.7%) |
| Ropinirole Cohort C | 0/30 (0%) | 0/30 (0%) | 19/30 (63.3%) |
| Event | Ropinirole Cohort A | Ropinirole Cohort B | Ropinirole Cohort C |
|---|---|---|---|
| PalpitationsCardiac disorders | 1/52 | 0/53 | 0/30 |
| Event | Ropinirole Cohort A | Ropinirole Cohort B | Ropinirole Cohort C |
|---|---|---|---|
| Pain in extremityMusculoskeletal and connective tissue disorders | 23/52 | 4/53 | 2/30 |
| HeadacheNervous system disorders | 16/52 | 18/53 | 5/30 |
| NauseaGastrointestinal disorders | 10/52 | 15/53 | 9/30 |
| DizzinessNervous system disorders | 7/52 | 2/53 | 2/30 |
| Restless legs syndromeMusculoskeletal and connective tissue disorders | 3/52 | 6/53 | 3/30 |
| VomitingGastrointestinal disorders | 1/52 | 5/53 | 3/30 |
| SomnolenceNervous system disorders | 4/52 | 3/53 | 2/30 |
| DyspepsiaGastrointestinal disorders | 4/52 | 2/53 | 0/30 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/52 | 1/53 | 0/30 |
| InsomniaNervous system disorders | 4/52 | 2/53 | 1/30 |
Safety population included all participants who entered into the study and who received at least one dose of the double-blind medication.
| Age, Continuous(Years) | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Total |
|---|---|---|---|---|---|---|---|
| Mean | 56.8 ± 12.91 | 57.4 ± 8.69 | 59.2 ± 10.21 | 53.7 ± 13.94 | 58.3 ± 11.96 | 57.1 ± 9.67 | 57.0 ± 11.44 |
| Sex: Female, Male(Participants) | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Total |
|---|---|---|---|---|---|---|---|
| Female | 20 | 18 | 14 | 18 | 7 | 7 | 84 |
| Male | 6 | 8 | 12 | 9 | 9 | 7 | 51 |
| Race (NIH/OMB)(Participants) | Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 0 | 0 | 1 | 0 | 3 |
| White | 25 | 24 | 25 | 27 | 15 | 14 | 130 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Ran from Nov 2005 to primary completion in Sep 2006, 10 months.
Results were first posted in Mar 2019, 12 years 5 months after primary completion.
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Studies of the drug tested here: Ropinirole