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A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 11, 2006
Last updated: April 13, 2015
Last verified: April 2015
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
Restless Legs Syndrome (RLS)
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

Secondary Outcome Measures:
  • Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.

Estimated 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)

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

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 identifier: NCT00363857

  Show 49 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00363857     History of Changes
Other Study ID Numbers: 101468/249 
Study First Received: August 11, 2006
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
sleep disorder
Restless Legs Syndrome

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on September 27, 2016