RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

October 17, 2016 updated by: GlaxoSmithKline

A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)

Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

568

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • GSK Investigational Site
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • GSK Investigational Site
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
  • Austria
      • Innsbruck, Austria, A-6020
        • GSK Investigational Site
      • Vienna, Austria, A-1090
        • GSK Investigational Site
  • Belgium
      • Brussels, Belgium, 1190
        • GSK Investigational Site
      • Charleroi, Belgium, 6000
        • GSK Investigational Site
      • Edegem, Belgium, 2650
        • GSK Investigational Site
      • Liege, Belgium, 4000
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
  • Denmark
      • Glostrup, Denmark, 2600
        • GSK Investigational Site
      • Hvidovre, Denmark, 2650
        • GSK Investigational Site
      • Koebenhavn NV, Denmark, 2300
        • GSK Investigational Site
      • Odense C, Denmark, DK-5000
        • GSK Investigational Site
  • France
      • Anzin, France, 59410
        • GSK Investigational Site
      • Bordeaux, France, 33000
        • GSK Investigational Site
      • Bron Cedex, France, 69677
        • GSK Investigational Site
      • Créteil, France, 94010
        • GSK Investigational Site
      • Grenoble Cedex 09, France, 38043
        • GSK Investigational Site
      • Lille, France, 59037
        • GSK Investigational Site
      • Montbrison, France, 42600
        • GSK Investigational Site
      • Nancy Cedex, France, 54035
        • GSK Investigational Site
      • Pessac Cedex, France, 33604
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 12163
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Germany, 80331
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19053
        • GSK Investigational Site
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09111
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Koethen, Sachsen-Anhalt, Germany, 06366
        • GSK Investigational Site
    • Thueringen
      • Gera, Thueringen, Germany, 07551
        • GSK Investigational Site
  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40123
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00168
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20127
        • GSK Investigational Site
      • Pavia, Lombardia, Italy, 27100
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • GSK Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 EC
        • GSK Investigational Site
      • Geldermalsen, Netherlands, 4191 AH
        • GSK Investigational Site
      • Grubbenvorst, Netherlands, 5971 BB
        • GSK Investigational Site
      • Hoogwoud, Netherlands, 1718 BG
        • GSK Investigational Site
      • Nieuwegein, Netherlands, 3435 CM
        • GSK Investigational Site
      • Roelofarendsveen, Netherlands, 2371 RB
        • GSK Investigational Site
      • Zwolle, Netherlands, 8025 BV
        • GSK Investigational Site
  • Norway
      • Bergen, Norway, 5094
        • GSK Investigational Site
      • Oslo, Norway, 0277
        • GSK Investigational Site
      • Sandvika, Norway, N-1338
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08025
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 08017
        • GSK Investigational Site
      • Granada, Spain, 18013
        • GSK Investigational Site
      • Madrid, Spain, 28036
        • GSK Investigational Site
      • Palma de Mallorca, Spain, 07014
        • GSK Investigational Site
      • San Sebastián, Spain, 20014
        • GSK Investigational Site
      • Zaragoza, Spain, 50009
        • GSK Investigational Site
  • Sweden
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
      • Göteborg, Sweden, SE-412 55
        • GSK Investigational Site
      • Helsingborg, Sweden, SE-252 21
        • GSK Investigational Site
      • Örebro, Sweden, 701 85
        • GSK Investigational Site
  • United Kingdom
      • Corsham, United Kingdom, SN13 8NA
        • GSK Investigational Site
      • Doncaster, United Kingdom, DN1 2EG
        • GSK Investigational Site
      • Ledbury, United Kingdom, HR8 2DX
        • GSK Investigational Site
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S40 4TF
        • GSK Investigational Site
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY4 3AD
        • GSK Investigational Site
    • Somerset
      • Frome, Somerset, United Kingdom, BA11 1EZ
        • GSK Investigational Site
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV6 4DD
        • GSK Investigational Site
    • Wiltshire
      • Trowbridge, Wiltshire, United Kingdom, BA14 9AR
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85210
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85050
        • GSK Investigational Site
      • Sun City, Arizona, United States, 85351
        • GSK Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • GSK Investigational Site
      • Burlingame, California, United States, 94010
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Newport Beach, California, United States, 92660
        • GSK Investigational Site
      • Pasadena, California, United States, 91106
        • GSK Investigational Site
      • Redondo Beach, California, United States, 90277
        • GSK Investigational Site
      • Santa Monica, California, United States, 90404
        • GSK Investigational Site
      • Stanford, California, United States, 94305-5548
        • GSK Investigational Site
      • Winnetka, California, United States, 91306
        • GSK Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • GSK Investigational Site
    • Idaho
      • Coeur D'Alene, Idaho, United States, 83814
        • GSK Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01104
        • GSK Investigational Site
      • West Yarmouth, Massachusetts, United States, 02673
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • GSK Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • GSK Investigational Site
    • Minnesota
      • St. Paul, Minnesota, United States, 55101
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63128
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12205
        • GSK Investigational Site
    • North Carolina
      • Tabor City, North Carolina, United States, 28463
        • GSK Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • GSK Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • GSK Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
  • Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.

Exclusion criteria:

  • Signs of secondary RLS.
  • Primary sleep disorder or movement disorder other than RLS.
  • Unstable medical conditions.
  • Inability to tolerate dopamine agonists or dopamine antagonists.
  • Unwilling to discontinue any medications currently being taken to treat RLS symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS.
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

April 13, 2006

First Submitted That Met QC Criteria

April 13, 2006

First Posted (ESTIMATE)

April 17, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101468/204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Clinical Study Report
    Information identifier: 101468/204
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: 101468/204
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 101468/204
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: 101468/204
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: 101468/204
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: 101468/204
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: 101468/204
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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