Last updated: 11/02/2018 23:33:46
Onset Motor Complications using REQUIP CR (ropinirole controlled-release) As Add-on Therapy To L-dopa In Parkinson's
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects.
Trial description: This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of participants with time to onset of dyskinesia
Timeframe: Up to 2 Years
Secondary outcomes:
Change from Baseline (Day 1) in united PD rating scale (UPDRS) activities of daily living (ADL) score (Part II) at Week 28 and 104
Timeframe: Baseline (Day 1), Week 28 and 104
Change from Baseline (Day 1) UPDRS motor score (UPDRS Part III) over period at Week 28 and Week 104
Timeframe: Baseline (Day 1), Week 28, and Week 104
Number of participants with symptoms of dyskinesia over period
Timeframe: Up to Week 104
Change from Baseline (Day 1) in fatigue score using epworth sleepiness scale (ESS) over period
Timeframe: Baseline (Day 1) and up to Week 104
Number of participants with reduced PD symptom control up to 96 weeks
Timeframe: Up to Week 96
Number of participants with a score of “much improved” or “very much improved” on the clinical global impression of improvement (CGI –I) up to 52 weeks
Timeframe: Up to 52 weeks
Mean change from Baseline (Day 1) in PD quality of life score (PDQ39) scale over period
Timeframe: Baseline (Day 1) and up to 104 weeks
Mini mental status examination (MMSE) score status at screening and Week 104
Timeframe: Screening and Week 104
Change from Baseline (Day 1) in total score on the beck depression inventory (BDI) over period
Timeframe: Baseline (Day 1) and up to Week 104
Change from Baseline (Day 1) in night-time quality of sleep scores of the PD sleep scale (PDSS) over period
Timeframe: Baseline (Day 1), Week 28, 52, 76, and 104
Number of participants of genes variants of interest with and without dyskinesia over period
Timeframe: Up to Week 104
Interventions:
Enrollment:
208
Primary completion date:
2006-11-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
R Watts, K Sethi, R Pahwa, B Adams, N Earl. Ropinirole 24-hour prolonged release delays the onset of dyskinesia Compared with carbidopa/levodopa in patients with Parkinson’s disease treated with levodopa. Eur J Neurol. 2007;14 (Issue s1):1-355 .
R Watts, K Sethi, R Pahwa, B Adams, N Earl. Ropinirole 24-hour prolonged release delays the onset of dyskinesia compared with carbidopa/levodopa in patients with Parkinson’s disease treated with levodopa. Movement Disorders. 2007;22 (Suppl.16):S94/307.
Medical condition
Parkinson's Disease, Dyskinesias
Product
ropinirole
Collaborators
Not applicable
Study date(s)
December 2003 to January 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
30 - 70 years
Accepts healthy volunteers
No
- Must be on 600mg or less of levodopa therapy for two years or less.
- Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening.
- Current or past history of Dyskinesia.
- State of dementia or have a MMSE score < 26 at screening.
Inclusion and exclusion criteria
Inclusion criteria:
- Must be on 600mg or less of levodopa therapy for two years or less.
- Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening.
Exclusion criteria:
- Current or past history of Dyskinesia.
- State of dementia or have a MMSE score < 26 at screening.
Trial location(s)
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Des Moines, Iowa, United States, 50309-1426
Status
Study Complete
Location
GSK Investigational Site
Alexandria, Virginia, United States, 22311
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Elkridge, Maryland, United States, 21075
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
Showing 1 - 6 of 70 Results
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
Study complete
Actual primary completion date
2006-11-01
Actual study completion date
2006-11-01
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
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