Restless Legs Syndrome Clinical Trial
— (CR-RLS)Official title:
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
Verified date | October 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility |
Inclusion criteria: - 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. Exclusion criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Anaheim | California |
United States | GSK Investigational Site | Atlanta | Georgia |
United States | GSK Investigational Site | Auburn | Maine |
United States | GSK Investigational Site | Austell | Georgia |
United States | GSK Investigational Site | Baton Rouge | Louisiana |
United States | GSK Investigational Site | Brandon | Florida |
United States | GSK Investigational Site | Brighton | Massachusetts |
United States | GSK Investigational Site | Charlotte | North Carolina |
United States | GSK Investigational Site | Cincinnati | Ohio |
United States | GSK Investigational Site | Cleveland | Ohio |
United States | GSK Investigational Site | Columbia | South Carolina |
United States | GSK Investigational Site | Corvallis | Oregon |
United States | GSK Investigational Site | Crestview Hills | Kentucky |
United States | GSK Investigational Site | Dallas | Texas |
United States | GSK Investigational Site | Danville | Indiana |
United States | GSK Investigational Site | Dublin | Ohio |
United States | GSK Investigational Site | Duncansville | Pennsylvania |
United States | GSK Investigational Site | Elk Grove Village | Illinois |
United States | GSK Investigational Site | Greenville | North Carolina |
United States | GSK Investigational Site | Greenwood | Colorado |
United States | GSK Investigational Site | Jasper | Alabama |
United States | GSK Investigational Site | Lafayette | Louisiana |
United States | GSK Investigational Site | Lafayette Hill | Pennsylvania |
United States | GSK Investigational Site | Las Vegas | Nevada |
United States | GSK Investigational Site | Lenexa | Kansas |
United States | GSK Investigational Site | Lexington | Kentucky |
United States | GSK Investigational Site | Little Rock | Arkansas |
United States | GSK Investigational Site | Louisville | Kentucky |
United States | GSK Investigational Site | Macon | Georgia |
United States | GSK Investigational Site | Normal | Illinois |
United States | GSK Investigational Site | Oklahoma City | Oklahoma |
United States | GSK Investigational Site | Pembroke Pines | Florida |
United States | GSK Investigational Site | Phoenix | Arizona |
United States | GSK Investigational Site | Portland | Oregon |
United States | GSK Investigational Site | Portland | Oregon |
United States | GSK Investigational Site | San Antonio | Texas |
United States | GSK Investigational Site | San Diego | California |
United States | GSK Investigational Site | St. Louis | Missouri |
United States | GSK Investigational Site | St. Petersburg | Florida |
United States | GSK Investigational Site | Toms River | New Jersey |
United States | GSK Investigational Site | Topeka | Kansas |
United States | GSK Investigational Site | Tulsa | Oklahoma |
United States | GSK Investigational Site | Tuscaloosa | Alabama |
United States | GSK Investigational Site | Walla Walla | Washington |
United States | GSK Investigational Site | Wheat Ridge | Colorado |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes. | 12 Weeks |
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