Trial · NCT00650104
Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164
NCT00650104, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164. Trials, record NCT00650104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00650104
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164
- NCT number
- NCT00650104
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 76 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Parkinson Disease
- Interventions
- Ropinirole XL (formerly CR)
- First posted
- 2008-04-01
- Last updated
- 2013-05-06
- Results first posted
- 2010-04-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78 | 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. |
| Primary | Number of Participants With the Indicated Number of Adverse Events (AEs) | Every study visit from baseline to market availability (Month 78) | 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. |
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) | Screening; Months 3, 9, 15, 27, and 78 | 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. |
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) | Screening; Months 3, 9, 15, 27, and 78 | 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. |
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population) | Screening and Month 78 | 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). |
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population) | Screening and Month 78 | 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). |
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population) | Screening and Month 78 | 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). |
| Secondary | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Week 2, Month 12, Month 78 | 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. |
| Secondary | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Week 2, Month 12, Month 78 | 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. |
| Secondary | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Week 2, Month 12, Month 78 | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78 | Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one treatment period evaluation for any parameter were included in the evaluation of the therapeutic benefit. Various n values are the result of participant attrition. | points on a scale | MEAN |
| PRIMARY | Number of Participants With the Indicated Number of Adverse Events (AEs) | Every study visit from baseline to market availability (Month 78) | All participants who received at least one dose of study medication. The treatment-emergent Study 196 AEs were defined as occurring during initial titration or long-term treatment or follow up. | participants | NUMBER |
| SECONDARY | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) | Screening; Months 3, 9, 15, 27, and 78 | Responder: a subset of the ITT Population containing those participants who had a score of 1 (very much improved) or 2 (much improved) on the clinical global impression (CGI) scale during the study. CGI-I scores (1 to 7 \[very much worse\]) the participant's condition relative to baseline. Various n values are the result of participant attrition. | points on a scale | MEAN |
| SECONDARY | Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) | Screening; Months 3, 9, 15, 27, and 78 | Maintained Responder : subset of the Responder Population, which was maintained or further decreased for a minimum of 4 weeks whilst the participant received a stable or decreasing dose of study medication. Various n values are the result of participant attrition. | points on a scale | MEAN |
| SECONDARY | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population) | Screening and Month 78 | Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition. | points on a scale | MEAN |
| SECONDARY | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population) | Screening and Month 78 | Responder Population. Various n values are the result of participant attrition. | points on a scale | MEAN |
| SECONDARY | Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population) | Screening and Month 78 | Maintained Responder Population. Various n values are the result of participant attrition. | points on a scale | MEAN |
| SECONDARY | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) | Week 2, Month 12, Month 78 | Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) | Week 2, Month 12, Month 78 | Responder Population. Various n values are the result of participant attrition. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) | Week 2, Month 12, Month 78 | Maintained Responder Population. Various n values are the result of participant attrition. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Ropinirole XL | Screening, n=83 | 9.4 | Standard Deviation 5.14 | points on a scale |
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Ropinirole XL | Up-titration (Week 4), n=64 | 8.9 | Standard Deviation 4.60 | points on a scale |
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Ropinirole XL | LTT, Month 3, n=76 | 8.2 | Standard Deviation 5.34 | points on a scale |
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Ropinirole XL | LTT, Month 9, n=72 | 8.1 | Standard Deviation 5.03 | points on a scale |
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Ropinirole XL | LTT, Month 15, n=67 | 9.0 | Standard Deviation 5.83 | points on a scale |
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Ropinirole XL | LTT, Month 21, n=63 | 8.6 | Standard Deviation 5.01 | points on a scale |
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Ropinirole XL | LTT, Month 27, n=58 | 9.3 | Standard Deviation 5.59 | points on a scale |
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Ropinirole XL | LTT, Month 33, n=53 | 10.3 | Standard Deviation 6.14 | points on a scale |
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Ropinirole XL | LTT, Month 39, n=19 | 10.5 | Standard Deviation 6.74 | points on a scale |
| Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) | Ropinirole XL | LTT, Month 45, n=18 | 9.3 | Standard Deviation 4.47 | points on a scale |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ropinirole XL | 83 | |
| Overall Study | COMPLETED | Ropinirole XL | 42 | |
| Overall Study | NOT COMPLETED | Ropinirole XL | 41 |
Source ClinicalTrials.gov
Adverse events122
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Ropinirole XL | 35 | 83 | |
| other | Dizziness | Nervous system disorders | Ropinirole XL | 34 | 83 | |
| other | Oedema peripheral | General disorders | Ropinirole XL | 32 | 83 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Ropinirole XL | 28 | 83 | |
| other | Headache | Nervous system disorders | Ropinirole XL | 26 | 83 | |
| other | Nasopharyngitis | Infections and infestations | Ropinirole XL | 24 | 83 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ropinirole XL | 23 | 83 | |
| other | Somnolence | Nervous system disorders | Ropinirole XL | 23 | 83 | |
| other | Insomnia | Psychiatric disorders | Ropinirole XL | 22 | 83 | |
| other | Constipation | Gastrointestinal disorders | Ropinirole XL | 21 | 83 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ropinirole XL | ||
| Total, other adverse events | Ropinirole XL | 83 | 83 |
| Total, serious adverse events | Ropinirole XL | 34 | 83 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21244307 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00650104
GET https://conductscience.org/api/trials/v1/NCT00650104/results?page=2