A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome
A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering From Restless Legs Syndrome (RLS)
1 other identifier
interventional
360
1 country
49
Brief Summary
A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2003
Shorter than P25 for phase_3
49 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
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 11, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedOctober 17, 2016
October 1, 2016
9 months
August 11, 2006
October 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in RLS severity rating scale at Week 12
Secondary Outcomes (1)
Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.
Interventions
Eligibility Criteria
You may qualify if:
- Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
- Patients must give written informed consent prior to any specific study procedures.
You may not qualify if:
- Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
- Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
- Patients suffering from other movement disorders (i.e. Parkinson's Disease).
- Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
- Participation in any clinical drug or device trial in the last three months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (49)
GSK Investigational Site
Alabaster, Alabama, 35007, United States
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Tuscaloosa, Alabama, 35406, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Berkeley, California, 94705, United States
GSK Investigational Site
La Jolla, California, 92037, 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
Stanford, California, 94305-5548, United States
GSK Investigational Site
Aurora, Colorado, 80012, United States
GSK Investigational Site
Danbury, Connecticut, 06810, United States
GSK Investigational Site
Boca Raton, Florida, 33486, 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
Tampa, Florida, 33609, United States
GSK Investigational Site
Atlanta, Georgia, 30329, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Macon, Georgia, 31201, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Elk Grove Village, Illinois, 60007, United States
GSK Investigational Site
Louisville, Kentucky, 40217, United States
GSK Investigational Site
Southfield, Michigan, 48034, United States
GSK Investigational Site
Henderson, Nevada, 89052, United States
GSK Investigational Site
Lebanon, New Hampshire, 03766, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Schenectady, New York, 12308, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Columbus, Ohio, 43210-1296, United States
GSK Investigational Site
Concinnati, Ohio, 45219, United States
GSK Investigational Site
Dublin, Ohio, 43017, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Portland, Oregon, 97201, United States
GSK Investigational Site
Lafayette Hill, Pennsylvania, 19444, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Nashville, Tennessee, 37205, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
Alexandria, Virginia, 22311, United States
GSK Investigational Site
Norfolk, Virginia, 23507, United States
GSK Investigational Site
Walla Walla, Washington, 99362, 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
August 11, 2006
First Posted
August 15, 2006
Study Start
August 1, 2003
Primary Completion
May 1, 2004
Study Completion
May 1, 2004
Last Updated
October 17, 2016
Record last verified: 2016-10
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.