Status:
COMPLETED
A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Â 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.
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00225862
Start Date
January 1 2005
End Date
December 1 2005
Last Update
September 15 2016
Active Locations (37)
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1
GSK Investigational Site
Alabaster, Alabama, United States, 35007
2
GSK Investigational Site
Jasper, Alabama, United States, 35501
3
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
4
GSK Investigational Site
Phoenix, Arizona, United States, 85032