12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome
(CR-RLS)
A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep
1 other identifier
interventional
39
1 country
45
Brief Summary
The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2006
Shorter than P25 for phase_4
45 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
First Submitted
Initial submission to the registry
September 7, 2006
CompletedFirst Posted
Study publicly available on registry
September 8, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedOctober 28, 2016
October 1, 2016
8 months
September 7, 2006
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12.
12 Weeks
Secondary Outcomes (1)
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.
12 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- provided written informed consent.
- Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
- Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
- Sleep efficiency \<85% OR Latency to persistent sleep \>20 minutes.
You may not qualify if:
- Secondary RLS
- Primary sleep disorder
- Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
- Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
- Use of any prohibited medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (45)
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Tuscaloosa, Alabama, 35406, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Anaheim, California, 92801, United States
GSK Investigational Site
San Diego, California, 92108, United States
GSK Investigational Site
Greenwood, Colorado, 80111, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Brandon, Florida, 33511, United States
GSK Investigational Site
Pembroke Pines, Florida, 33026, United States
GSK Investigational Site
St. Petersburg, Florida, 33707, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Austell, Georgia, 30106, United States
GSK Investigational Site
Macon, Georgia, 31201, United States
GSK Investigational Site
Elk Grove Village, Illinois, 60007, United States
GSK Investigational Site
Normal, Illinois, 61761, United States
GSK Investigational Site
Danville, Indiana, 46122, United States
GSK Investigational Site
Lenexa, Kansas, 66214, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Crestview Hills, Kentucky, 41017, United States
GSK Investigational Site
Lexington, Kentucky, 40509, United States
GSK Investigational Site
Louisville, Kentucky, 40217, United States
GSK Investigational Site
Baton Rouge, Louisiana, 70808, United States
GSK Investigational Site
Lafayette, Louisiana, 70503, United States
GSK Investigational Site
Auburn, Maine, 04210, United States
GSK Investigational Site
Brighton, Massachusetts, 02135, United States
GSK Investigational Site
St Louis, Missouri, 63143, United States
GSK Investigational Site
Las Vegas, Nevada, 89104, United States
GSK Investigational Site
Toms River, New Jersey, 08755, United States
GSK Investigational Site
Charlotte, North Carolina, 28204, United States
GSK Investigational Site
Greenville, North Carolina, 27835, United States
GSK Investigational Site
Cincinnati, Ohio, 45246, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
Dublin, Ohio, 43017, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Tulsa, Oklahoma, 74104, United States
GSK Investigational Site
Corvallis, Oregon, 97330, United States
GSK Investigational Site
Portland, Oregon, 97219, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
GSK Investigational Site
Duncansville, Pennsylvania, 16635, United States
GSK Investigational Site
Lafayette Hill, Pennsylvania, 19444, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Dallas, Texas, 75213, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Walla Walla, Washington, 99362, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2006
First Posted
September 8, 2006
Study Start
October 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
October 28, 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.