A Phase 3 interventional study of Ropinirole XL (formerly CR) in Parkinson Disease, sponsored by GlaxoSmithKline. Completed at 10 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2013-05-06.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 76 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
Open label medication - Ropinirole CR
Drug: Ropinirole XL (formerly CR)
Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day.
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.
Time frame: Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78
Number of Participants With the Indicated Number of Adverse Events (AEs)
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
Time frame: Every study visit from baseline to market availability (Month 78)
Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.
Time frame: Screening; Months 3, 9, 15, 27, and 78
Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)
The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.
Time frame: Screening; Months 3, 9, 15, 27, and 78
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)
Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).
Time frame: Screening and Month 78
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)
Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).
Time frame: Screening and Month 78
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)
Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).
Time frame: Screening and Month 78
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)
The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.
Time frame: Week 2, Month 12, Month 78
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)
The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.
Time frame: Week 2, Month 12, Month 78
Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.
Time frame: Week 2, Month 12, Month 78
| Milestone | Ropinirole XL |
|---|---|
| Started | 83 |
| Completed | 42 |
| Not completed | 41 |
| Withdrew: Adverse event | 17 |
| Withdrew: Death | 2 |
| Withdrew: Withdrawal by subject | 11 |
| Withdrew: Physician decision | 7 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Non-compliance | 2 |
| Withdrew: Sponsor terminated dosing | 1 |
The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.
| points on a scale | Ropinirole XL |
|---|---|
| Screening, n=83 | 9.4 ± 5.14 |
| Up-titration (Week 4), n=64 | 8.9 ± 4.60 |
| LTT, Month 3, n=76 | 8.2 ± 5.34 |
| LTT, Month 9, n=72 | 8.1 ± 5.03 |
| LTT, Month 15, n=67 | 9.0 ± 5.83 |
| LTT, Month 21, n=63 | 8.6 ± 5.01 |
| LTT, Month 27, n=58 | 9.3 ± 5.59 |
| LTT, Month 33, n=53 | 10.3 ± 6.14 |
| LTT, Month 39, n=19 | 10.5 ± 6.74 |
| LTT, Month 45, n=18 | 9.3 ± 4.47 |
| LTT, Month 51, n=19 | 10.1 ± 6.07 |
| LTT, Month 57, n=20 | 10.4 ± 5.80 |
| LTT, Month 63, n=19 | 11.9 ± 7.23 |
| LTT, Month 69, n=20 | 10.8 ± 6.70 |
| LTT, Month 75, n=16 | 12.6 ± 6.66 |
| LTT, Month 78, n=13 | 11.5 ± 6.64 |
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
| participants | Ropinirole XL |
|---|---|
| Participants (Par.) with at least one event | 81 |
| Par. with 0 events | 2 |
| Par. with 1 event | 1 |
| Par. with 2 events | 0 |
| Par. with ≥3 events | 80 |
| Par. with mild AEs (by maximum intensity) | 3 |
| Par. with moderate AEs (by maximum intensity) | 38 |
| Par. with severe AEs (by maximum intensity) | 40 |
| Par. with AEs not related to st. med. | 6 |
| Par. with AEs not likely related to st. med. | 6 |
| Par. with AEs suspected to be related to st. med. | 36 |
| Par. with AEs probably related to st. med. | 33 |
| Par. who withdrew study due to AEs | 20 |
| Par. reporting SAEs | 35 |
The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.
| points on a scale | Ropinirole XL |
|---|---|
| Screening, n=60 | 9.1 ± 5.08 |
| LTT, Month 3, n=59 | 8.0 ± 5.18 |
| LTT, Month 9, n=58 | 7.8 ± 4.92 |
| LTT, Month 15, n=55 | 8.7 ± 5.76 |
| LTT, Month 27, n=47 | 8.8 ± 5.80 |
| LTT, Month 78, n=13 | 11.5 ± 6.64 |
The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.
| points on a scale | Ropinirole XL |
|---|---|
| Screening, n=47 | 9.0 ± 5.33 |
| LTT, Month 3, n=46 | 7.7 ± 5.53 |
| LTT, Month 9, n= 46 | 7.7 ± 5.09 |
| LTT, Month 15, n=44 | 8.6 ± 5.97 |
| LTT, Month 27, n=37 | 8.4 ± 5.68 |
| LTT, Month 78, n=13 | 11.5 ± 6.64 |
Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).
| points on a scale | Ropinirole XL |
|---|---|
| Screening, n=83 | 22.0 ± 10.14 |
| Month 78, n=13 | 20.7 ± 7.09 |
Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).
| points on a scale | Ropinirole XL |
|---|---|
| Screening, n=60 | 21.7 ± 9.71 |
| Month 78, n=13 | 20.7 ± 7.09 |
Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).
| points on a scale | Ropinirole XL |
|---|---|
| Screening, n=47 | 22.2 ± 10.11 |
| Month 78, n=13 | 20.7 ± 7.09 |
The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.
| participants | Ropinirole XL |
|---|---|
| Week 2 - Very Much Improved, n=70 | 0 |
| Week 2 - Much Improved, n=70 | 2 |
| Week 2 - Minimally Improved, n=70 | 20 |
| Week 2 - No Change, n=70 | 43 |
| Week 2 - Minimally Worse, n=70 | 4 |
| Week 2 - Much Worse, n=70 | 1 |
| Week 2 - Very Much Worse, n=70 | 0 |
| Month 12 - Very Much Improved, n=69 | 7 |
| Month 12 - Much Improved, n=69 | 25 |
| Month 12 - Minimally Improved, n=69 | 20 |
| Month 12 - No Change, n=69 | 7 |
| Month 12 - Minimally Worse, n=69 | 8 |
| Month 12 - Much Worse, n=69 | 1 |
| Month 12 - Very Much Worse, n=69 | 0 |
| Month 78 -Very Much Improved, n=13 | 1 |
| Month 78 - Much Improved, n=13 | 8 |
| Month 78 - Minimally Improved, n=13 | 1 |
| Month 78 - No Change, n=13 | 1 |
| Month 78 - Minimally Worse, n=13 | 1 |
| Month 78 - Much Worse, n=13 | 0 |
| Month 78 - Very Much Worse, n=13 | 0 |
The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.
| participants | Ropinirole XL |
|---|---|
| Week 2 - Very Much Improved, n=49 | 0 |
| Week 2 - Much Improved, n=49 | 2 |
| Week 2 - Minimally Improved, n=49 | 17 |
| Week 2 - No Change, n=49 | 27 |
| Week 2 - Minimally Worse, n=49 | 2 |
| Week 2 - Much Worse, n=49 | 1 |
| Week 2 - Very Much Worse, n=49 | 0 |
| Month 12 - Very Much Improved, n=56 | 7 |
| Month 12 - Much Improved, n=56 | 25 |
| Month 12 - Minimally Improved, n=56 | 12 |
| Month 12 - No Change, n=56 | 5 |
| Month 12 - Minimally Worse, n=56 | 5 |
| Month 12 - Much Worse, n=56 | 1 |
| Month 12 - Very Much Worse, n=56 | 0 |
| Month 78 - Very Much Improved, n=13 | 1 |
| Month 78 - Much Improved, n=13 | 8 |
| Month 78 - Minimally Improved, n=13 | 1 |
| Month 78 - No Change, n=13 | 1 |
| Month 78 - Minimally Worse, n=13 | 1 |
| Month 78 - Much Worse, n=13 | 0 |
| Month 78 - Very Much Worse, n=13 | 0 |
The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician's view of the participant's global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.
| participants | Ropinirole XL |
|---|---|
| Week 2 - Very Much Improved, n=37 | 0 |
| Week 2 - Much Improved, n=37 | 2 |
| Week 2 - Minimally Improved, n=37 | 12 |
| Week 2 - No Change, n=37 | 20 |
| Week 2 - Minimally Worse, n=37 | 2 |
| Week 2 - Much Worse, n=37 | 1 |
| Week 2 - Very Much Worse, n=37 | 0 |
| Month 12 - Very Much Improved, n=46 | 6 |
| Month 12 - Much Improved, n=46 | 23 |
| Month 12 - Minimally Improved, n=46 | 7 |
| Month 12 - No Change, n=46 | 4 |
| Month 12 - Minimally Worse, n=46 | 4 |
| Month 12 - Much Worse, n=46 | 1 |
| Month 12 - Very Much Worse, n=46 | 0 |
| Month 78 - Very Much Improved, n=13 | 1 |
| Month 78 - Much Improved, n=13 | 8 |
| Month 78 - Minimally Improved, n=13 | 1 |
| Month 78 - No Change, n=13 | 1 |
| Month 78 - Minimally Worse, n=13 | 1 |
| Month 78 - Much Worse, n=13 | 0 |
| Month 78 - Very Much Worse, n=13 | 0 |
Collected over On therapy adverse events (AEs) were defined as occurring after administration of the first dose of study medication and on or before the final visit. AEs were reviewed and recorded at every visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ropinirole XL | — | 34/83 (41%) | 83/83 (100%) |
| Event | Ropinirole XL |
|---|---|
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/83 |
| Chest painGeneral disorders | 4/83 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 4/83 |
| Non-cardiac chest painGeneral disorders | 2/83 |
| Angina pectorisCardiac disorders | 2/83 |
| Coronary heart diseaseCardiac disorders | 2/83 |
| OverdoseInjury, poisoning and procedural complications | 2/83 |
| Intervertebral disc protusionMusculoskeletal and connective tissue disorders | 2/83 |
| Muscle strainMusculoskeletal and connective tissue disorders | 2/83 |
| ScoliosisMusculoskeletal and connective tissue disorders | 2/83 |
| Event | Ropinirole XL |
|---|---|
| NauseaGastrointestinal disorders | 35/83 |
| DizzinessNervous system disorders | 34/83 |
| Oedema peripheralGeneral disorders | 32/83 |
| Back painMusculoskeletal and connective tissue disorders | 28/83 |
| HeadacheNervous system disorders | 26/83 |
| NasopharyngitisInfections and infestations | 24/83 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 23/83 |
| SomnolenceNervous system disorders | 23/83 |
| InsomniaPsychiatric disorders | 22/83 |
| ConstipationGastrointestinal disorders | 21/83 |
| Age Continuous(years) | Ropinirole XL |
|---|---|
| Mean | 65.1 ± 9.85 |
| Sex: Female, Male(Participants) | Ropinirole XL |
|---|---|
| Female | 37 |
| Male | 46 |
| Race/Ethnicity, Customized(participants) | Ropinirole XL |
|---|---|
| Caucasian | 74 |
| Hispanic | 6 |
| Black | 1 |
| Asian | 1 |
| Other | 1 |
| Weight(kilograms (kg)) | Ropinirole XL |
|---|---|
| Mean | 79.24 ± 16.8 |
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