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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00225862
First received: June 30, 2005
Last updated: September 29, 2010
Last verified: September 2010

June 30, 2005
September 29, 2010
January 2005
December 2005   (final data collection date for primary outcome measure)
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. [ Time Frame: 12 Weeks ]
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.
Complete list of historical versions of study NCT00225862 on ClinicalTrials.gov Archive Site
Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication. [ Time Frame: 12 Weeks ]
Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.
Not Provided
Not Provided
 
A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)
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)

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.

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 (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
140
December 2005
December 2005   (final data collection date for primary outcome measure)

 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.
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00225862
100310
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
September 2010

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