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Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

NCT ID: NCT00197080

Last Updated: 2016-09-23

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

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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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 Extended Release (XR)

Intervention Type DRUG

Eligibility Criteria

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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.
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

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Jasper, Alabama, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Anaheim, California, United States

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Northridge, California, United States

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Oxnard, California, United States

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Pasadena, California, United States

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Redondo Beach, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Wheat Ridge, Colorado, United States

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Largo, Florida, United States

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Pembroke Pines, Florida, United States

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Stuart, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Austell, Georgia, United States

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Dawsonville, Georgia, United States

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Macon, Georgia, United States

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Woodstock, Georgia, United States

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Northbrook, Illinois, United States

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Lenexa, Kansas, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Newton, Massachusetts, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Endwell, New York, United States

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Kingston, New York, United States

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Schenectady, New York, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Dublin, Ohio, United States

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Westerville, 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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Columbia, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Jackson, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Alexandria, Virginia, United States

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Charlottesville, Virginia, United States

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Bellingham, Washington, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Walla Walla, Washington, United States

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Wenatchee, Washington, United States

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Edmonton, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Langley, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Ajax, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Regina, Saskatchewan, Canada

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Countries

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United States Canada

Study Documents

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Document Type: Study Protocol

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: Annotated Case Report Form

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

View Document

Document Type: Informed Consent Form

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: Individual Participant Data Set

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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101468/205

Identifier Type: -

Identifier Source: org_study_id

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