12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome ((CR-RLS))
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00373542
First received: September 7, 2006
Last updated: March 15, 2012
Last verified: March 2011
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Purpose
The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.
| Condition | Intervention | Phase |
|---|---|---|
|
Restless Legs Syndrome Restless Legs Syndrome (RLS) |
Drug: ropinirole CR-RLS |
Phase 4 |
| 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, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12. [ Time Frame: 12 Weeks ]
Secondary Outcome Measures:
- Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes. [ Time Frame: 12 Weeks ]
| Enrollment: | 216 |
| Study Start Date: | October 2006 |
Intervention Details:
-
Drug: ropinirole CR-RLS
Other Name: ropinirole CR-RLS
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- provided written informed consent.
- Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
- Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
- Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.
Exclusion criteria:
- Secondary RLS
- Primary sleep disorder
- Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
- Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
- Use of any prohibited medication.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373542
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Hide Study LocationsLocations
| United States, Alabama | |
| GSK Investigational Site | |
| Jasper, Alabama, United States, 35501 | |
| United States, Arizona | |
| GSK Investigational Site | |
| Phoenix, Arizona, United States, 85006 | |
| United States, Arkansas | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| GSK Investigational Site | |
| Anaheim, California, United States, 92801 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Wheat Ridge, Colorado, United States, 80033 | |
| United States, Florida | |
| GSK Investigational Site | |
| Brandon, Florida, United States, 33511 | |
| GSK Investigational Site | |
| Pembroke Pines, Florida, United States, 33026 | |
| GSK Investigational Site | |
| St. Petersburg, Florida, United States, 33707 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| GSK Investigational Site | |
| Austell, Georgia, United States, 30106 | |
| GSK Investigational Site | |
| Macon, Georgia, United States, 31201 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Normal, Illinois, United States, 61761 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Danville, Indiana, United States, 46122 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Lenexa, Kansas, United States, 66214 | |
| GSK Investigational Site | |
| Topeka, Kansas, United States, 66606 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Crestview Hills, Kentucky, United States, 41017 | |
| GSK Investigational Site | |
| Lexington, Kentucky, United States, 40509 | |
| GSK Investigational Site | |
| Louisville, Kentucky, United States, 40217 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Baton Rouge, Louisiana, United States, 70808 | |
| GSK Investigational Site | |
| Lafayette, Louisiana, United States, 70503 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Brighton, Massachusetts, United States, 02135 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89104 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Toms River, New Jersey, United States, 08755 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Charlotte, North Carolina, United States, 28204 | |
| GSK Investigational Site | |
| Greenville, North Carolina, United States, 27835 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Cincinnati, Ohio, United States, 45246 | |
| GSK Investigational Site | |
| Dublin, Ohio, United States, 43017 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| GSK Investigational Site | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Corvallis, Oregon, United States, 97330 | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97219 | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Duncansville, Pennsylvania, United States, 16635 | |
| 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 | |
| Dallas, Texas, United States, 75213 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| 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
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00373542 History of Changes |
| Other Study ID Numbers: | RRL103660 |
| Study First Received: | September 7, 2006 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
polysomnography RLS ropinirole Restless Legs Syndrome PSG |
Additional relevant MeSH terms:
|
Restless Legs Syndrome Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations |
Signs and Symptoms Ropinirole Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013