12-Week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00373542

Purpose

The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

Condition	Intervention	Phase
Restless Legs Syndrome (RLS)	Drug: ropinirole CR-RLS	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs Sleep Disorders

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes. [ Time Frame: 12 Weeks ]

Enrollment:	216
Study Start Date:	October 2006

Eligibility

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

Criteria

Inclusion criteria:

provided written informed consent.
Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS 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.
Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.

Exclusion criteria:

Secondary RLS
Primary sleep disorder
Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
Use of any prohibited medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373542

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Locations

United States, Alabama
GSK Investigational Site
Jasper, Alabama, United States, 35501
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Anaheim, California, United States, 92801
United States, Colorado
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Florida
GSK Investigational Site
Pembroke Pines, Florida, United States, 33026
GSK Investigational Site
St. Petersburg, Florida, United States, 33707
GSK Investigational Site
Brandon, Florida, United States, 33511
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Macon, Georgia, United States, 31201
GSK Investigational Site
Austell, Georgia, United States, 30106
United States, Illinois
GSK Investigational Site
Normal, Illinois, United States, 61761
United States, Indiana
GSK Investigational Site
Danville, Indiana, United States, 46122
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
Crestview Hills, Kentucky, United States, 41017
GSK Investigational Site
Louisville, Kentucky, United States, 40217
GSK Investigational Site
Lexington, Kentucky, United States, 40509
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
United States, Massachusetts
GSK Investigational Site
Brighton, Massachusetts, United States, 02135
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New Jersey
GSK Investigational Site
Toms River, New Jersey, United States, 08755
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
GSK Investigational Site
Greenville, North Carolina, United States, 27835
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
GSK Investigational Site
Dublin, Ohio, United States, 43017
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97219
GSK Investigational Site
Corvallis, Oregon, United States, 97330
GSK Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
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
Dallas, Texas, United States, 75213
United States, Washington
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:	RRL103660
Study First Received:	September 7, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00373542 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Restless Legs Syndrome
RLS
ropinirole
polysomnography
PSG

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 22, 2009