A Clinical Research Study Testing Ropinirole Treatment for 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 in Patients Suffering From Restless Legs Syndrome (RLS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363857
• Other study ID #: 101468/249
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2006
• Last updated: October 14, 2016
• Start date: August 2003
• Est. completion date: May 2004

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Other inclusion or exclusion criteria to be evaluated by the physician.

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
• Restless Legs Syndrome (RLS)
• Syndrome

Intervention

Drug:
• Ropinirole

Locations

Country	Name	City	State
United States	GSK Investigational Site	Alabaster	Alabama
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Alexandria	Virginia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Berkeley	California
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boca Raton	Florida
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Concinnati	Ohio
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Danbury	Connecticut
United States	GSK Investigational Site	Dublin	Ohio
United States	GSK Investigational Site	Elk Grove Village	Illinois
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	La Jolla	California
United States	GSK Investigational Site	Lafayette Hill	Pennsylvania
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Lebanon	New Hampshire
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	Nashville	Tennessee
United States	GSK Investigational Site	Norfolk	Virginia
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	Pembroke Pines	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Plano	Texas
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	Santa Monica	California
United States	GSK Investigational Site	Schenectady	New York
United States	GSK Investigational Site	Southfield	Michigan
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	Stanford	California
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tuscaloosa	Alabama
United States	GSK Investigational Site	Walla Walla	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in RLS severity rating scale at Week 12			No
Secondary	Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.			No

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.