Restless Legs Syndrome
Conditions
Keywords
Restless Legs Syndrome, RLS
Brief summary
The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).
Interventions
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
* Diagnosed with RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS Rating Scale. * Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
Exclusion criteria
* Have secondary RLS. * Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12. | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12. | 12 Weeks |
Countries
Canada, United States
Outcome results
None listed