RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

GlaxoSmithKline568 enrolled

Overview

Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

568

Conditions

Restless Legs Syndrome Restless Legs Syndrome (RLS)

Interventions

ropinirole Extended Release (XR)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria. * Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment. Exclusion criteria: * Signs of secondary RLS. * Primary sleep disorder or movement disorder other than RLS. * Unstable medical conditions. * Inability to tolerate dopamine agonists or dopamine antagonists. * Unwilling to discontinue any medications currently being taken to treat RLS symptoms.

Locations (91)

Outcomes

Primary Outcomes

To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms

Time frame: 12 Weeks

Secondary Outcomes

To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS.

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Mesa, 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

Burlingame, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Pasadena, California, United States

GSK Investigational Site

Redondo Beach, California, United States

...and 81 more locations