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

Phase 3CompletedNCT00197080

GlaxoSmithKline380 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

380

Conditions

Restless Legs Syndrome

Interventions

Ropinirole Extended Release (XR)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (70)

Outcomes

Primary Outcomes

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

Time frame: 12 Weeks

Secondary Outcomes

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.

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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GSK Investigational Site

Alabaster, Alabama, United States

GSK Investigational Site

Jasper, Alabama, United States

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Peoria, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Sun City, Arizona, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Northridge, California, United States

GSK Investigational Site

Oxnard, California, United States

GSK Investigational Site

Pasadena, California, United States

...and 60 more locations