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

Last updated: October 17, 2016
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Williams Syndrome

Dyskinesias

Manic Disorders

Treatment

N/A

Clinical Study ID

NCT00314860
101468/204
  • Ages 18-79
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview andInternational 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

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 Design

Total Participants: 568
Study Start date:
February 01, 2006
Estimated Completion Date:
December 31, 2006

Connect with a study center

  • GSK Investigational Site

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • GSK Investigational Site

    Auchenflower, Queensland 4066
    Australia

    Site Not Available

  • GSK Investigational Site

    Kippa Ring, Queensland 4021
    Australia

    Site Not Available

  • GSK Investigational Site

    Innsbruck, A-6020
    Austria

    Site Not Available

  • GSK Investigational Site

    Vienna, A-1090
    Austria

    Site Not Available

  • GSK Investigational Site

    Brussels, 1190
    Belgium

    Site Not Available

  • GSK Investigational Site

    Charleroi, 6000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Edegem, 2650
    Belgium

    Site Not Available

  • GSK Investigational Site

    Liege, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Liège, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Liège, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Glostrup, 2600
    Denmark

    Site Not Available

  • GSK Investigational Site

    Hvidovre, 2650
    Denmark

    Site Not Available

  • GSK Investigational Site

    Koebenhavn NV, 2300
    Denmark

    Site Not Available

  • GSK Investigational Site

    Odense C, DK-5000
    Denmark

    Site Not Available

  • GSK Investigational Site

    Anzin, 59410
    France

    Site Not Available

  • GSK Investigational Site

    Bordeaux, 33000
    France

    Site Not Available

  • GSK Investigational Site

    Bron Cedex, 69677
    France

    Site Not Available

  • GSK Investigational Site

    Créteil, 94010
    France

    Site Not Available

  • GSK Investigational Site

    Créteil, 94010
    France

    Site Not Available

  • GSK Investigational Site

    Grenoble Cedex 09, 38043
    France

    Site Not Available

  • GSK Investigational Site

    Lille, 59037
    France

    Site Not Available

  • GSK Investigational Site

    Montbrison, 42600
    France

    Site Not Available

  • GSK Investigational Site

    Nancy Cedex, 54035
    France

    Site Not Available

  • GSK Investigational Site

    Pessac Cedex, 33604
    France

    Site Not Available

  • GSK Investigational Site

    Muenchen, Bayern 80331
    Germany

    Site Not Available

  • GSK Investigational Site

    Schwerin, Mecklenburg-Vorpommern 19053
    Germany

    Site Not Available

  • GSK Investigational Site

    Chemnitz, Sachsen 09111
    Germany

    Site Not Available

  • GSK Investigational Site

    Koethen, Sachsen-Anhalt 06366
    Germany

    Site Not Available

  • GSK Investigational Site

    Gera, Thueringen 07551
    Germany

    Site Not Available

  • GSK Investigational Site

    Berlin, 12163
    Germany

    Site Not Available

  • GSK Investigational Site

    Bologna, Emilia-Romagna 40123
    Italy

    Site Not Available

  • GSK Investigational Site

    Roma, Lazio 00168
    Italy

    Site Not Available

  • GSK Investigational Site

    Milano, Lombardia 20127
    Italy

    Site Not Available

  • GSK Investigational Site

    Pavia, Lombardia 27100
    Italy

    Site Not Available

  • GSK Investigational Site

    Pisa, Toscana 56126
    Italy

    Site Not Available

  • GSK Investigational Site

    Amsterdam, 1066 EC
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Geldermalsen, 4191 AH
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Grubbenvorst, 5971 BB
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Hoogwoud, 1718 BG
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Nieuwegein, 3435 CM
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Roelofarendsveen, 2371 RB
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Zwolle, 8025 BV
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Bergen, 5094
    Norway

    Site Not Available

  • GSK Investigational Site

    Oslo, 0277
    Norway

    Site Not Available

  • GSK Investigational Site

    Sandvika, N-1338
    Norway

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08025
    Spain

    Site Not Available

  • GSK Investigational Site

    Granada, 18013
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28036
    Spain

    Site Not Available

  • GSK Investigational Site

    Palma de Mallorca, 07014
    Spain

    Site Not Available

  • GSK Investigational Site

    San Sebastián, 20014
    Spain

    Site Not Available

  • GSK Investigational Site

    San Sebastián, 20014
    Spain

    Site Not Available

  • GSK Investigational Site

    Zaragoza, 50009
    Spain

    Site Not Available

  • GSK Investigational Site

    Göteborg, SE-413 45
    Sweden

    Site Not Available

  • GSK Investigational Site

    Göteborg, SE-412 55
    Sweden

    Site Not Available

  • GSK Investigational Site

    Helsingborg, SE-252 21
    Sweden

    Site Not Available

  • GSK Investigational Site

    Örebro, 701 85
    Sweden

    Site Not Available

  • GSK Investigational Site

    Örebro, 701 85
    Sweden

    Site Not Available

  • GSK Investigational Site

    Chesterfield, Derbyshire S40 4TF
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Blackpool, Lancashire FY4 3AD
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Frome, Somerset BA11 1EZ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Coventry, Warwickshire CV6 4DD
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Trowbridge, Wiltshire BA14 9AR
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Corsham, SN13 8NA
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Doncaster, DN1 2EG
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Ledbury, HR8 2DX
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • GSK Investigational Site

    Mesa, Arizona 85210
    United States

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85050
    United States

    Site Not Available

  • GSK Investigational Site

    Sun City, Arizona 85351
    United States

    Site Not Available

  • GSK Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • GSK Investigational Site

    Burlingame, California 94010
    United States

    Site Not Available

  • GSK Investigational Site

    Long Beach, California 90806
    United States

    Site Not Available

  • GSK Investigational Site

    Newport Beach, California 92660
    United States

    Site Not Available

  • GSK Investigational Site

    Pasadena, California 91106
    United States

    Site Not Available

  • GSK Investigational Site

    Redondo Beach, California 90277
    United States

    Site Not Available

  • GSK Investigational Site

    Santa Monica, California 90404
    United States

    Site Not Available

  • GSK Investigational Site

    Stanford, California 94305-5548
    United States

    Site Not Available

  • GSK Investigational Site

    Winnetka, California 91306
    United States

    Site Not Available

  • GSK Investigational Site

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • GSK Investigational Site

    Coeur D'Alene, Idaho 83814
    United States

    Site Not Available

  • GSK Investigational Site

    Springfield, Massachusetts 01104
    United States

    Site Not Available

  • GSK Investigational Site

    West Yarmouth, Massachusetts 02673
    United States

    Site Not Available

  • GSK Investigational Site

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • GSK Investigational Site

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • GSK Investigational Site

    St. Paul, Minnesota 55101
    United States

    Site Not Available

  • GSK Investigational Site

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • GSK Investigational Site

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • GSK Investigational Site

    Albany, New York 12205
    United States

    Site Not Available

  • GSK Investigational Site

    Tabor City, North Carolina 28463
    United States

    Site Not Available

  • GSK Investigational Site

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • GSK Investigational Site

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • GSK Investigational Site

    Burlington, Vermont 05401
    United States

    Site Not Available

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