Phase 3
Completed N=83
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
Source: ClinicalTrials.gov NCT00650104 ↗Enrolled (actual)
83
Serious AEs
41.0%
Results posted
Apr 2010
Primary outcomePrimary: Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) — 9.4; 8.9; 8.2; 8.1 points on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) |
9.4; 8.9; 8.2; 8.1; 9.0; 8.6 | — |
| PRIMARY Number of Participants With the Indicated Number of Adverse Events (AEs) |
81; 2; 1; 0; 80; 3 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) |
9.1; 8.0; 7.8; 8.7; 8.8; 11.5 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) |
9.0; 7.7; 7.7; 8.6; 8.4; 11.5 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population) |
22.0; 20.7 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population) |
21.7; 20.7 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population) |
22.2; 20.7 | — |
| SECONDARY Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) |
0; 2; 20; 43; 4; 1 | — |
| SECONDARY Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) |
0; 2; 17; 27; 2; 1 | — |
| SECONDARY Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) |
0; 2; 12; 20; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Males or non-pregnant/non-breast feeding females
- At least 30 years of age
- Diagnosis of idiopathic Parkinson''s disease (Hoehn & Yahr criteria)
- Completed either Study 167 or Study 164
Exclusion Criteria
- Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy
- Dizziness or fainting due to orthostatic hypotension on standing
- Significant sleep disorder
- Drug abuse or alcoholism
Data sourced from ClinicalTrials.gov (NCT00650104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.