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

This study has been completed.

First Received on September 13, 2005. Last Updated on March 17, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00197080

Purpose

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).

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: Ropinirole Extended Release (XR)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Estimated Enrollment:	380
Study Start Date:	June 2005

Intervention Details:

Other Name: Ropinirole Extended Release (XR)

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197080

Show 68 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00197080 History of Changes
Other Study ID Numbers:	101468/205
Study First Received:	September 13, 2005
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Restless Legs Syndrome
RLS

Additional relevant MeSH terms:

Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations

Signs and Symptoms
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012