Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197080
First received: September 13, 2005
Last updated: February 13, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).
| Condition | Intervention | Phase |
|---|---|---|
|
Restless Legs Syndrome Restless Legs Syndrome (RLS) |
Drug: Ropinirole Extended Release (XR) |
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 XR (Extended Release) in Patients With Restless Legs Syndrome |
Resource links provided by NLM:
Genetics Home Reference related topics:
restless legs syndrome
MedlinePlus related topics:
Restless Legs
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12. [ Time Frame: 12 Weeks ]
Secondary Outcome Measures:
- Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12. [ Time Frame: 12 Weeks ]
| Estimated Enrollment: | 380 |
| Study Start Date: | June 2005 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Ropinirole Extended Release (XR)
Other Name: Ropinirole Extended Release (XR)
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Diagnosed with RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS 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.
Exclusion criteria:
- Have secondary RLS.
- Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
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: NCT00197080
Show 68 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197080
Show 68 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00197080 History of Changes |
| Other Study ID Numbers: | 101468/205 |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by GlaxoSmithKline:
|
Restless Legs Syndrome RLS |
Additional relevant MeSH terms:
|
Psychomotor Agitation Restless Legs Syndrome Syndrome Disease Dyskinesias Dyssomnias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Parasomnias Pathologic Processes Psychomotor Disorders Signs and Symptoms |
Sleep Disorders Sleep Disorders, Intrinsic Ropinirole Anti-Dyskinesia Agents Antiparkinson Agents Central Nervous System Agents Dopamine Agents Dopamine Agonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015