A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

Restless Legs Syndrome Clinical Trial

Official title:

A 12-week, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225862
• Other study ID #: 100310
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: September 13, 2016
• Start date: January 2005
• Est. completion date: December 2005

Study information

• Verified date: September 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 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

 Inclusion criteria:

• Patients diagnosed with Restless Legs Syndrome (RLS).

• Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement).

• Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

• Patients with a primary sleep disorder other than RLS.

• Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).

• 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
• 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	Albuquerque	New Mexico
United States	GSK Investigational Site	Amherst	New York
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Bingham Farms	Michigan
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Concinnati	Ohio
United States	GSK Investigational Site	Edison	New Jersey
United States	GSK Investigational Site	Elk Grove Village	Illinois
United States	GSK Investigational Site	Fairfield	Connecticut
United States	GSK Investigational Site	Flossmoor	Illinois
United States	GSK Investigational Site	Frederick	Maryland
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Lafayette Hill	Pennsylvania
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	New Hyde Park	New York
United States	GSK Investigational Site	Newton	Massachusetts
United States	GSK Investigational Site	Newton Center	Massachusetts
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	Peoria	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Redondo Beach	California
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Topeka	Kansas
United States	GSK Investigational Site	Walla Walla	Washington
United States	GSK Investigational Site	Wenatchee	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.		12 Weeks
Secondary	Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.		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.