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12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome | Clinical Trials | Clareo Health

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12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

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

NCT00373542•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

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.

Locations (45)

GSK Investigational Site

Jasper, Alabama, United States

GSK Investigational Site

Tuscaloosa, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Greenwood, Colorado, United States

GSK Investigational Site

Wheat Ridge, Colorado, United States

GSK Investigational Site

Brandon, Florida, United States

GSK Investigational Site

Pembroke Pines, Florida, United States

Key Dates

Start Date

October 1, 2006

Primary Completion Date

June 1, 2007

Completion Date

June 1, 2007

Last Updated

October 28, 2016

Enrollment

ACTUAL participants

Conditions

Restless Legs Syndrome (RLS)Restless Legs Syndrome

Interventions

ropinirole CR-RLS

DRUG

Functional Connectivity of the Interoceptive Network in RLS

NCT07001891

Restless Legs Syndrome

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RECRUITINGNA

The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

NCT05908214

StrokeCramp+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

Inclusion Criteria

Exclusion Criteria

Functional Connectivity of the Interoceptive Network in RLS

The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

Quality Improvement and Practice Based Research in Neurology Using the EMR

A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS

Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database

Impact of Iron Supplementation Treatment on Brain Iron Concentrations