A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)
A 12-week, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)
1 other identifier
interventional
140
1 country
37
Brief Summary
A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.
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 Jan 2005
Shorter than P25 for phase_3
37 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
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 26, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedSeptember 15, 2016
September 1, 2016
June 30, 2005
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.
12 Weeks
Secondary Outcomes (1)
Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.
12 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- Patients diagnosed with Restless Legs Syndrome (RLS).
- Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement).
- Patients must give written informed consent prior to any specific study procedures.
You may not qualify if:
- Patients with a primary sleep disorder other than RLS.
- Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (37)
GSK Investigational Site
Alabaster, Alabama, 35007, United States
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Peoria, Arizona, 85381 - 4828, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Northridge, California, 91325, United States
GSK Investigational Site
Oxnard, California, 93030, United States
GSK Investigational Site
Redondo Beach, California, 90277, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Fairfield, Connecticut, 06824, United States
GSK Investigational Site
Largo, Florida, 33773, United States
GSK Investigational Site
Pembroke Pines, Florida, 33026, United States
GSK Investigational Site
St. Petersburg, Florida, 33701, United States
GSK Investigational Site
Tampa, Florida, 33606, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Elk Grove Village, Illinois, 60007, United States
GSK Investigational Site
Flossmoor, Illinois, 60422, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Baton Rouge, Louisiana, 70808, United States
GSK Investigational Site
Frederick, Maryland, 21702, United States
GSK Investigational Site
Newton, Massachusetts, 02459, United States
GSK Investigational Site
Newton Center, Massachusetts, 02459, United States
GSK Investigational Site
Bingham Farms, Michigan, 48025, United States
GSK Investigational Site
Edison, New Jersey, 08818, United States
GSK Investigational Site
Albuquerque, New Mexico, 87106, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Amherst, New York, 14226, United States
GSK Investigational Site
New Hyde Park, New York, 11040, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Concinnati, Ohio, 45219, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Lafayette Hill, Pennsylvania, 19444, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Walla Walla, Washington, 99362, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
Related Links
MeSH Terms
Conditions
Interventions
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
June 30, 2005
First Posted
September 26, 2005
Study Start
January 1, 2005
Study Completion
December 1, 2005
Last Updated
September 15, 2016
Record last verified: 2016-09
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.