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A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363857
First received: August 11, 2006
Last updated: October 14, 2016
Last verified: October 2016
  Purpose
A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.

Condition Intervention Phase
Restless Legs Syndrome (RLS)
Restless Legs Syndrome
Drug: Ropinirole
Phase 3

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 in Patients Suffering From Restless Legs Syndrome (RLS)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Improvement in RLS severity rating scale at Week 12 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12. [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: August 2003
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
  • Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

  • Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
  • Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
  • Patients suffering from other movement disorders (i.e. Parkinson's Disease).
  • Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
  • Participation in any clinical drug or device trial in the last three months.

Other inclusion or exclusion criteria to be evaluated by the physician.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363857

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Alabaster, Alabama, United States, 35007
GSK Investigational Site
Birmingham, Alabama, United States, 35294
GSK Investigational Site
Jasper, Alabama, United States, 35501
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85032
GSK Investigational Site
Phoenix, Arizona, United States, 85050
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Berkeley, California, United States, 94705
GSK Investigational Site
La Jolla, California, United States, 92037
GSK Investigational Site
Northridge, California, United States, 91325
GSK Investigational Site
Oxnard, California, United States, 93030
GSK Investigational Site
Redondo Beach, California, United States, 90277
GSK Investigational Site
Santa Monica, California, United States, 90404
GSK Investigational Site
Stanford, California, United States, 94305-5548
United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80012
United States, Connecticut
GSK Investigational Site
Danbury, Connecticut, United States, 06810
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33486
GSK Investigational Site
Largo, Florida, United States, 33773
GSK Investigational Site
Pembroke Pines, Florida, United States, 33026
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
GSK Investigational Site
Tampa, Florida, United States, 33606
GSK Investigational Site
Tampa, Florida, United States, 33609
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30329
GSK Investigational Site
Augusta, Georgia, United States, 30912
GSK Investigational Site
Macon, Georgia, United States, 31201
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60611
GSK Investigational Site
Elk Grove Village, Illinois, United States, 60007
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40217
United States, Michigan
GSK Investigational Site
Southfield, Michigan, United States, 48034
United States, Nevada
GSK Investigational Site
Henderson, Nevada, United States, 89052
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03766
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
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
Columbus, Ohio, United States, 43210-1296
GSK Investigational Site
Concinnati, Ohio, United States, 45219
GSK Investigational Site
Dublin, Ohio, United States, 43017
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97201
United States, Pennsylvania
GSK Investigational Site
Lafayette Hill, Pennsylvania, United States, 19444
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29201
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37205
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78756
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
Plano, Texas, United States, 75093
United States, Virginia
GSK Investigational Site
Alexandria, Virginia, United States, 22311
GSK Investigational Site
Norfolk, Virginia, United States, 23507
United States, Washington
GSK Investigational Site
Walla Walla, Washington, United States, 99362
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 101468/249
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 101468/249
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 101468/249
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 101468/249
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 101468/249
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 101468/249
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 101468/249
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363857     History of Changes
Other Study ID Numbers: 101468/249 
Study First Received: August 11, 2006
Last Updated: October 14, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
fatigue
sleep
sleep disorder
Legs
RLS
Restless Legs Syndrome
Ropinirole

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016