MedDataX Logo

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

NCT ID: NCT00373542

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Restless Legs Syndrome (RLS) Restless Legs Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Restless Legs Syndrome ropinirole polysomnography RLS PSG

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ropinirole CR-RLS

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Jasper, Alabama, United States

Site Status

GSK Investigational Site

Tuscaloosa, Alabama, United States

Site Status

GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Anaheim, California, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

Greenwood, Colorado, United States

Site Status

GSK Investigational Site

Wheat Ridge, Colorado, United States

Site Status

GSK Investigational Site

Brandon, Florida, United States

Site Status

GSK Investigational Site

Pembroke Pines, Florida, United States

Site Status

GSK Investigational Site

St. Petersburg, Florida, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Austell, Georgia, United States

Site Status

GSK Investigational Site

Macon, Georgia, United States

Site Status

GSK Investigational Site

Elk Grove Village, Illinois, United States

Site Status

GSK Investigational Site

Normal, Illinois, United States

Site Status

GSK Investigational Site

Danville, Indiana, United States

Site Status

GSK Investigational Site

Lenexa, Kansas, United States

Site Status

GSK Investigational Site

Topeka, Kansas, United States

Site Status

GSK Investigational Site

Crestview Hills, Kentucky, United States

Site Status

GSK Investigational Site

Lexington, Kentucky, United States

Site Status

GSK Investigational Site

Louisville, Kentucky, United States

Site Status

GSK Investigational Site

Baton Rouge, Louisiana, United States

Site Status

GSK Investigational Site

Lafayette, Louisiana, United States

Site Status

GSK Investigational Site

Auburn, Maine, United States

Site Status

GSK Investigational Site

Brighton, Massachusetts, United States

Site Status

GSK Investigational Site

St Louis, Missouri, United States

Site Status

GSK Investigational Site

Las Vegas, Nevada, United States

Site Status

GSK Investigational Site

Toms River, New Jersey, United States

Site Status

GSK Investigational Site

Charlotte, North Carolina, United States

Site Status

GSK Investigational Site

Greenville, North Carolina, United States

Site Status

GSK Investigational Site

Cincinnati, Ohio, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Dublin, Ohio, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

Tulsa, Oklahoma, United States

Site Status

GSK Investigational Site

Corvallis, Oregon, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Duncansville, Pennsylvania, United States

Site Status

GSK Investigational Site

Lafayette Hill, Pennsylvania, United States

Site Status

GSK Investigational Site

Columbia, South Carolina, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Walla Walla, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RRL103660

Identifier Type: -

Identifier Source: org_study_id