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A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 11, 2006
Last updated: April 13, 2015
Last verified: April 2015

August 11, 2006
April 13, 2015
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Restless Legs Syndrome
  • Restless Legs Syndrome (RLS)
Drug: Ropinirole
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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.

18 Years to 79 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Study Director: GSK Clinical Trials GlaxoSmithKline
April 2015

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