Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00197080 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : September 23, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Restless Legs Syndrome | Drug: Ropinirole Extended Release (XR) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 380 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 Ropinirole XR (Extended Release) in Patients With Restless Legs Syndrome |
Study Start Date : | June 2005 |
Actual Study Completion Date : | January 2006 |

- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT00197080

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00197080 |
Other Study ID Numbers: |
101468/205 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | September 23, 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. |
Restless Legs Syndrome RLS |
Psychomotor Agitation Restless Legs Syndrome Syndrome Disease Pathologic Processes Dyskinesias Neurologic Manifestations Nervous System Diseases Psychomotor Disorders Neurobehavioral Manifestations 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 |