Last updated: 11/02/2018 23:29:25
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Unified Parkinson’s Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)
Timeframe: 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)
Timeframe: Every study visit from baseline to market availability (Month 78)
Secondary outcomes:
Unified Parkinson’s Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)
Timeframe: Screening; Months 3, 9, 15, 27, and 78
Unified Parkinson’s Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)
Timeframe: Screening; Months 3, 9, 15, 27, and 78
Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)
Timeframe: Screening and Month 78
Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)
Timeframe: Screening and Month 78
Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)
Timeframe: Screening and Month 78
Number of participants with the indicated responses for CGI Global Impression (CGI-I) (ITT Population)
Timeframe: Week 2, Month 12, Month 78
Number of participants with the indicated responses for CGI Global Impression (CGI-I) (Responder Population)
Timeframe: Week 2, Month 12, Month 78
Number of participants with the indicated responses for CGI Global Impression (CGI-I) (Maintained Responder Population)
Timeframe: Week 2, Month 12, Month 78
Interventions:
Drug: Ropinirole XL (formerly CR)
Enrollment:
76
Observational study model:
Not applicable
Primary completion date:
2009-20-03
Time perspective:
Not applicable
Clinical publications:
Robert A. Hauser, Heinz Reichmann, Mark Lew, Afsaneh Asgharian, Clare Makumi, Kenneth Shulman. Long-term, open-label study of once-daily ropinirole prolonged release in early Parkinson’s disease. [Int J Neurosci]. 2011;Online.
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
Not applicable
Study date(s)
May 2002 to March 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
30+ years
Accepts healthy volunteers
No
- Males or non-pregnant/non-breast feeding females
- At least 30 years of age
- Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy
- Dizziness or fainting due to orthostatic hypotension on standing
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
Status
Study Complete
Location
GSK Investigational Site
Oxnard, California, United States, 93030
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Kansas, United States, 66160
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
Status
Study Complete
Location
GSK Investigational Site
Edison, New Jersey, United States, 08818
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-20-03
Actual study completion date
2009-20-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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