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A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00225862
First received: June 30, 2005
Last updated: September 13, 2016
Last verified: September 2016
  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
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 Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)

Resource links provided by NLM:


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
Study Completion Date: December 2005
  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).
  • 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
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: NCT00225862

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Alabaster, Alabama, United States, 35007
GSK Investigational Site
Jasper, Alabama, United States, 35501
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
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
United States, Connecticut
GSK Investigational Site
Fairfield, Connecticut, United States, 06824
United States, Florida
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
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60611
GSK Investigational Site
Elk Grove Village, Illinois, United States, 60007
GSK Investigational Site
Flossmoor, Illinois, United States, 60422
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, 87106
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
GSK Investigational Site
Amherst, New York, United States, 14226
GSK Investigational Site
New Hyde Park, New York, United States, 11040
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
Austin, Texas, United States, 78756
GSK Investigational Site
Plano, Texas, United States, 75093
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
GSK Investigational Site
Walla Walla, Washington, United States, 99362
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 100310
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: 100310
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: 100310
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 100310
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 100310
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: 100310
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 100310
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00225862     History of Changes
Other Study ID Numbers: 100310 
Study First Received: June 30, 2005
Last Updated: September 13, 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:
RLS
Restless Legs Syndrome

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