A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS) - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00225862

Purpose

A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.

Condition	Intervention	Phase
Restless Legs Syndrome (RLS)	Drug: ropinirole	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 Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)

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:

Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication. [ Time Frame: 12 Weeks ]

Enrollment:	140
Study Start Date:	January 2005

Eligibility

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

Criteria

Â Inclusion criteria:

Patients diagnosed with Restless Legs Syndrome (RLS).
Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement).
Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

Patients with a primary sleep disorder other than RLS.
Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).
Other inclusion or exclusion criteria to be evaluated by the physician.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225862

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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
Peoria, Arizona, United States, 85381 - 4828
GSK Investigational Site
Phoenix, Arizona, United States, 85032
United States, California
GSK Investigational Site
Santa Monica, California, United States, 90404
GSK Investigational Site
Oxnard, California, United States, 93030
GSK Investigational Site
Redondo Beach, California, United States, 90277
GSK Investigational Site
Northridge, California, United States, 91325
United States, Connecticut
GSK Investigational Site
Fairfield, Connecticut, United States, 06824
United States, Florida
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
GSK Investigational Site
Pembroke Pines, Florida, United States, 33026
GSK Investigational Site
Largo, Florida, United States, 33773
GSK Investigational Site
Tampa, Florida, United States, 33606
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60611
GSK Investigational Site
Flossmoor, Illinois, United States, 60422
GSK Investigational Site
Elk Grove Village, Illinois, United States, 60007
United States, Kansas
GSK Investigational Site
Topeka, Kansas, United States, 66606
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Maryland
GSK Investigational Site
Frederick, Maryland, United States, 21702
United States, Massachusetts
GSK Investigational Site
Newton Center, Massachusetts, United States, 02459
GSK Investigational Site
Newton, Massachusetts, United States, 02459
United States, Michigan
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
United States, New Jersey
GSK Investigational Site
Edison, New Jersey, United States, 08818
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, New York
GSK Investigational Site
Amherst, New York, United States, 14226
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Investigational Site
Concinnati, Ohio, United States, 45219
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
GSK Investigational Site
Lafayette Hill, Pennsylvania, United States, 19444
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Austin, Texas, United States, 78756
GSK Investigational Site
Plano, Texas, United States, 75093
United States, Washington
GSK Investigational Site
Wenatchee, Washington, United States, 98801
GSK Investigational Site
Walla Walla, Washington, United States, 99362

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:	100310
Study First Received:	June 30, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00225862 History of Changes
Health Authority:	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