Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

Restless Legs Syndrome Clinical Trial

Official title:

A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients With Restless Legs Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197080
• Other study ID #: 101468/205
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 22, 2016
• Start date: June 2005
• Est. completion date: January 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion criteria:

• Diagnosed with RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS 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.

Exclusion criteria:

• Have secondary RLS.

• Have any medical conditions that may impact efficacy assessments or that may present a safety concern.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Ropinirole Extended Release (XR)

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Ajax	Ontario
Canada	GSK Investigational Site	Coquitlam	British Columbia
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Langley	British Columbia
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Regina	Saskatchewan
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Trois Rivieres	Quebec
United States	GSK Investigational Site	Alabaster	Alabama
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Alexandria	Virginia
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Austell	Georgia
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Bellingham	Washington
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dawsonville	Georgia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Dublin	Ohio
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Jackson	Tennessee
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Kingston	New York
United States	GSK Investigational Site	Lafayette Hill	Pennsylvania
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lenexa	Kansas
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Macon	Georgia
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Mount Pleasant	South Carolina
United States	GSK Investigational Site	Newton	Massachusetts
United States	GSK Investigational Site	Northbrook	Illinois
United States	GSK Investigational Site	Northridge	California
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oxnard	California
United States	GSK Investigational Site	Pasadena	California
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Peoria	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Redondo Beach	California
United States	GSK Investigational Site	Renton	Washington
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Schenectady	New York
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Stuart	Florida
United States	GSK Investigational Site	Sun City	Arizona
United States	GSK Investigational Site	Topeka	Kansas
United States	GSK Investigational Site	Walla Walla	Washington
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	Westerville	Ohio
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.		12 Weeks
Secondary	Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12.		12 Weeks

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.