Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's
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.
1 other identifier
interventional
209
1 country
69
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2003
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 7, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedJanuary 18, 2017
January 1, 2017
2.1 years
August 7, 2006
January 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with time to onset of dyskinesia of treatment over 104 weeks (2 years)
Median time to dyskinesia could not be estimated by Kaplan-Meier methods because of the small number of events; however, number of participants with dyskinesia requiring days from the date of randomization (Day 1) to the date at which a participant has the event of interest were reported
Up to 2 Years
Secondary Outcomes (11)
Change from Baseline (Day 1) in united PD rating scale (UPDRS) activities of daily living (ADL) score (Part II) at Week 28 and 104
At Weeks 28 and 104
Change from Baseline (Day 1) UPDRS motor score (UPDRS Part III) over period at Week 28 and Week 104
Baseline (Day 1), Week 28, and Week 104
Number of participants with symptoms of dyskinesia over period
Upto week 106
Change from Baseline (Day 1) in fatigue score using epworth sleepiness scale (ESS) over period
Baseline (Day 1) and up to Week 104
Percentage of participants with reduced PD symptom control up to 96 weeks
Up to Week 96
- +6 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Current or past history of Dyskinesia.
- State of dementia or have a MMSE score \< 26 at screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (69)
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Birmingham, Alabama, 35216, United States
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Sun City, Arizona, 85351, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
La Jolla, California, 92037, United States
GSK Investigational Site
Los Angeles, California, 90033, United States
GSK Investigational Site
Newport Beach, California, 92660, United States
GSK Investigational Site
Oxnard, California, 93030, United States
GSK Investigational Site
San Jose, California, 95126, United States
GSK Investigational Site
Walnut Creek, California, 94596, United States
GSK Investigational Site
Boulder, Colorado, 80304, United States
GSK Investigational Site
Danbury, Connecticut, 06810, United States
GSK Investigational Site
Newark, Delaware, 19713, United States
GSK Investigational Site
Boca Raton, Florida, 33486, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33145, United States
GSK Investigational Site
Gainesville, Florida, 32611, United States
GSK Investigational Site
Miami, Florida, 33143, United States
GSK Investigational Site
Palm Beach Gardens, Florida, 33410, United States
GSK Investigational Site
Pembroke Pines, Florida, 33026, United States
GSK Investigational Site
Port Charlotte, Florida, 33952, United States
GSK Investigational Site
Tampa, Florida, 33606, United States
GSK Investigational Site
Tampa, Florida, 33612, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Austell, Georgia, 30106, United States
GSK Investigational Site
Columbus, Georgia, 31901, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Boise, Idaho, 83702, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Hoffman Estates, Illinois, 60194, United States
GSK Investigational Site
Northbrook, Illinois, 60062, United States
GSK Investigational Site
Des Moines, Iowa, 50309-1426, United States
GSK Investigational Site
Kansas City, Kansas, 66160, United States
GSK Investigational Site
Elkridge, Maryland, 21075, United States
GSK Investigational Site
South Weymouth, Massachusetts, 2190, United States
GSK Investigational Site
West Yarmouth, Massachusetts, 02673, United States
GSK Investigational Site
Bingham Farms, Michigan, 48025, United States
GSK Investigational Site
Grand Rapids, Michigan, 49503, United States
GSK Investigational Site
Traverse City, Michigan, 49684, United States
GSK Investigational Site
Las Vegas, Nevada, 89109, United States
GSK Investigational Site
Edison, New Jersey, 08818, United States
GSK Investigational Site
Albany, New York, 12205, United States
GSK Investigational Site
Amherst, New York, 14226, United States
GSK Investigational Site
Rochester, New York, 14603, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27516, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cincinnati, Ohio, 45267-0525, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Medford, Oregon, 97504-8456, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Dallas, Texas, 75235, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77081, United States
GSK Investigational Site
Lubbock, Texas, 79410, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Alexandria, Virginia, 22311, United States
GSK Investigational Site
Richmond, Virginia, 23226, United States
GSK Investigational Site
Roanoke, Virginia, 24014, United States
GSK Investigational Site
Kirkland, Washington, 98034, United States
GSK Investigational Site
Seattle, Washington, 98101, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Charleston, West Virginia, 25301, United States
GSK Investigational Site
Madison, Wisconsin, 53715, United States
Related Publications (2)
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 .
BACKGROUNDR 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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2006
First Posted
August 15, 2006
Study Start
December 1, 2003
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
January 18, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.