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

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

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

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

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

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Locations

United States, Alabama
GSK Investigational Site
Jasper, Alabama, United States, 35501
GSK Investigational Site
Alabaster, Alabama, United States, 35007
United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85201
GSK Investigational Site
Phoenix, Arizona, United States, 85032
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
GSK Investigational Site
Sun City, Arizona, United States, 85351
United States, California
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
Pasadena, California, United States, 91105
GSK Investigational Site
Santa Monica, California, United States, 90404
GSK Investigational Site
Redondo Beach, California, United States, 90277
GSK Investigational Site
Oxnard, California, United States, 93030
GSK Investigational Site
Northridge, California, United States, 91325
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
GSK Investigational Site
Denver, Colorado, United States, 80212
United States, Florida
GSK Investigational Site
Largo, Florida, United States, 33773
GSK Investigational Site
Pembroke Pines, Florida, United States, 33026
GSK Investigational Site
Stuart, Florida, United States, 34996
United States, Georgia
GSK Investigational Site
Woodstock, Georgia, United States, 30189
GSK Investigational Site
Atlanta, Georgia, United States, 30338
GSK Investigational Site
Macon, Georgia, United States, 31201
GSK Investigational Site
Dawsonville, Georgia, United States, 30534
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Austell, Georgia, United States, 30106
United States, Illinois
GSK Investigational Site
Northbrook, Illinois, United States, 60062
United States, Kansas
GSK Investigational Site
Topeka, Kansas, United States, 66606
GSK Investigational Site
Lenexa, Kansas, United States, 66214
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40217
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
GSK Investigational Site
Newton, Massachusetts, United States, 02459
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
GSK Investigational Site
Kingston, New York, United States, 12401
GSK Investigational Site
Endwell, New York, United States, 13760
GSK Investigational Site
Albany, New York, United States, 12205
GSK Investigational Site
Schenectady, New York, United States, 12308
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44130
GSK Investigational Site
Dublin, Ohio, United States, 43017
GSK Investigational Site
Westerville, Ohio, United States, 43081
GSK Investigational Site
Cincinnati, Ohio, United States, 45236
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97219
United States, Pennsylvania
GSK Investigational Site
Lafayette Hill, Pennsylvania, United States, 19444
United States, South Carolina
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
GSK Investigational Site
Columbia, South Carolina, United States, 29201
United States, Tennessee
GSK Investigational Site
Jackson, Tennessee, United States, 38305
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Dallas, Texas, United States, 75231
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
GSK Investigational Site
Salt Lake City, Utah, United States, 84102
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22911
GSK Investigational Site
Alexandria, Virginia, United States, 22311
United States, Washington
GSK Investigational Site
Spokane, Washington, United States, 99204
GSK Investigational Site
Renton, Washington, United States, 98055
GSK Investigational Site
Bellingham, Washington, United States, 98226
GSK Investigational Site
Walla Walla, Washington, United States, 99362
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3J 3T1
Canada, Ontario
GSK Investigational Site
Ajax, Ontario, Canada, L1S 2J5
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
GSK Investigational Site
Montreal, Quebec, Canada, H4J 1C5
GSK Investigational Site
Trois Rivieres, Quebec, Canada, G8Z 4K4
GSK Investigational Site
Montreal, Quebec, Canada, H2T 2N6
Canada, Saskatchewan
GSK Investigational Site
Regina, Saskatchewan, Canada, S4P 0W5

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	101468/205, SK&F-101468/205
Study First Received:	September 13, 2005
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00197080 History of Changes
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

Additional relevant MeSH terms:

Ropinirole
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Sleep Disorders
Antiparkinson Agents
Psychomotor Agitation
Dopamine Agonists
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Syndrome

Therapeutic Uses
Restless Legs Syndrome
Psychomotor Disorders
Neurobehavioral Manifestations
Disease
Parasomnias
Nervous System Diseases
Dyssomnias
Dyskinesias
Pharmacologic Actions
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009