A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00363857
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):

August 11, 2006
August 15, 2006
October 17, 2016
August 2003
May 2004   (Final data collection date for primary outcome measure)
Improvement in RLS severity rating scale at Week 12
Same as current
Complete list of historical versions of study NCT00363857 on Archive Site
Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.
Same as current
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A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome
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)
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Restless Legs Syndrome (RLS)
  • Restless Legs Syndrome
Drug: Ropinirole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2004
May 2004   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through following the timelines and process described on this site.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP