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

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ClinicalTrials.gov Identifier: NCT00225862
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: ropinirole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : January 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication. [ Time Frame: 12 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225862


  Show 37 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

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
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
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:
Restless Legs Syndrome
Syndrome
Psychomotor Agitation
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