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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

  Show 37 Study Locations
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 September 23, 2016