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A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363857
First received: August 11, 2006
Last updated: November 15, 2012
Last verified: November 2012

August 11, 2006
November 15, 2012
August 2003
Not Provided
Improvement in RLS severity rating scale at Week 12
Same as current
Complete list of historical versions of study NCT00363857 on ClinicalTrials.gov 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
Not Provided
Not Provided
 
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
Interventional
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
Other Name: Ropinirole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
Not Provided
Not Provided

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.

Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00363857
101468/249
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

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