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A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

NCT ID: NCT00363857

Last Updated: 2016-10-17

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-05-31

Brief Summary

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A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.

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Detailed Description

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Conditions

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Restless Legs Syndrome (RLS) Restless Legs Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ropinirole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
* Patients must give written informed consent prior to any specific study procedures.

Exclusion Criteria

* Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
* Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
* Patients suffering from other movement disorders (i.e. Parkinson's Disease).
* Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
* Participation in any clinical drug or device trial in the last three months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Alabaster, Alabama, United States

Site Status

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Birmingham, Alabama, United States

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Jasper, Alabama, United States

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Tuscaloosa, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Berkeley, California, United States

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La Jolla, California, United States

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Northridge, California, United States

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Oxnard, California, United States

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Redondo Beach, California, United States

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Santa Monica, California, United States

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Stanford, California, United States

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Aurora, Colorado, United States

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Danbury, Connecticut, United States

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Boca Raton, Florida, United States

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Largo, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Macon, Georgia, United States

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Chicago, Illinois, United States

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Elk Grove Village, Illinois, United States

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Louisville, Kentucky, United States

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Southfield, Michigan, United States

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Henderson, Nevada, United States

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Lebanon, New Hampshire, United States

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Albuquerque, New Mexico, United States

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Schenectady, New York, United States

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Raleigh, North Carolina, United States

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Columbus, Ohio, United States

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Concinnati, Ohio, United States

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Dublin, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Lafayette Hill, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Plano, Texas, United States

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Alexandria, Virginia, United States

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Norfolk, Virginia, United States

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GSK Investigational Site

Walla Walla, Washington, United States

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Countries

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United States

Study Documents

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Document Type: Informed Consent Form

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

View Document

Document Type: Individual Participant Data Set

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

View Document

Document Type: Dataset Specification

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

View Document

Document Type: Clinical Study Report

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Annotated Case Report Form

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Related Links

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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

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101468/249

Identifier Type: -

Identifier Source: org_study_id

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