Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome - Full Text View

Sponsored by:	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 (RLS)	Drug: Ropinirole Extended Release (XR)	Phase III

MedlinePlus related topics: Restless Legs

Drug Information available for: Ropinirole Ropinirole hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

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

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

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	101468/205, SK&F-101468/205
Study First Received:	September 13, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00197080
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Restless Legs Syndrome
RLS

Study placed in the following topic categories:

Ropinirole
Ekbom syndrome
Sleep Disorders
Dyssomnias
Psychomotor Agitation
Dyskinesias
Sleep Disorders, Intrinsic

Signs and Symptoms
Dopamine
Mental Disorders
Restless Legs Syndrome
Neurologic Manifestations
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Nervous System Diseases
Parasomnias
Antiparkinson Agents

Dopamine Agonists
Pharmacologic Actions
Pathologic Processes
Syndrome
Therapeutic Uses
Psychomotor Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009