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

Condition(s) targeted: Restless Legs Syndrome

Intervention: Ropinirole Extended Release (XR) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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).

Official title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients With Restless Legs Syndrome

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.

Secondary outcome: 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.

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

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.

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Starting date: June 2005
Last updated: June 25, 2007