Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Drug: Ropinirole Extended Release (XR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00197080

101468/205

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind