Restless Legs Syndrome
Conditions
Keywords
RLS, Restless Legs Syndrome
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.
Interventions
DRUGropinirole
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication. | 12 Weeks |
Countries
United States
Outcome results
None listed