Restless Legs Syndrome, Restless Legs Syndrome (RLS)
Conditions
Keywords
fatigue, sleep, sleep disorder, Legs, RLS, Restless Legs Syndrome, Ropinirole
Brief summary
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.
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in RLS severity rating scale at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12. | — |
Countries
United States
Outcome results
None listed