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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00314860
First received: April 13, 2006
Last updated: September 20, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Restless Legs Syndrome
Restless Legs Syndrome (RLS)
Drug: ropinirole Extended Release (XR)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 480
Study Start Date: February 2006
Intervention Details:
    Drug: ropinirole Extended Release (XR)
    Other Name: ropinirole Extended Release (XR)
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314860

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35209
United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85210
GSK Investigational Site
Phoenix, Arizona, United States, 85050
GSK Investigational Site
Sun City, Arizona, United States, 85351
United States, California
GSK Investigational Site
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
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33486
United States, Massachusetts
GSK Investigational Site
Springfield, Massachusetts, United States, 01104
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West Yarmouth, Massachusetts, United States, 02673
GSK Investigational Site
Worcester, Massachusetts, United States, 01655
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
GSK Investigational Site
St. Paul, Minnesota, United States, 55101
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
United States, New York
GSK Investigational Site
Albany, New York, United States, 12205
United States, North Carolina
GSK Investigational Site
Tabor City, North Carolina, United States, 28463
United States, North Dakota
GSK Investigational Site
Fargo, North Dakota, United States, 58104
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Rhode Island
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
United States, Vermont
GSK Investigational Site
Burlington, Vermont, United States, 05401
Australia, New South Wales
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Austria
GSK Investigational Site
Innsbruck, Austria, A-6020
Belgium
GSK Investigational Site
Brussels, Belgium, 1190
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Charleroi, Belgium, 6000
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Edegem, Belgium, 2650
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Liège, Belgium, 4000
Denmark
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Glostrup, Denmark, 2600
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Hvidovre, Denmark, 2650
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Koebenhavn NV, Denmark, 2300
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Odense C, Denmark, DK-5000
France
GSK Investigational Site
Anzin, France, 59410
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Bordeaux, France, 33000
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Bron Cedex, France, 69677
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Créteil, France, 94010
GSK Investigational Site
Grenoble Cedex 09, France, 38043
GSK Investigational Site
Lille, France, 59037
GSK Investigational Site
Montbrison, France, 42600
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Nancy Cedex, France, 54035
GSK Investigational Site
Pessac Cedex, France, 33604
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
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Schwerin, Mecklenburg-Vorpommern, Germany, 19053
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Chemnitz, Sachsen, Germany, 09111
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Gera, Thueringen, Germany, 07551
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Berlin, Germany, 12163
Italy
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Bologna, Emilia-Romagna, Italy, 40123
GSK Investigational Site
Roma, Lazio, Italy, 00168
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Pavia, Lombardia, Italy, 27100
GSK Investigational Site
Pisa, Toscana, Italy, 56126
Netherlands
GSK Investigational Site
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
Norway
GSK Investigational Site
Bergen, Norway, 5094
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Sandvika, Norway, N-1338
Spain
GSK Investigational Site
Barcelona, Spain, 08035
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Barcelona, Spain, 08017
GSK Investigational Site
Barcelona, Spain, 08025
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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
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-412 55
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Örebro, Sweden, 701 85
United Kingdom
GSK Investigational Site
Chesterfield, Derbyshire, United Kingdom, S40 4TF
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Blackpool, Lancashire, United Kingdom, FY4 3AD
GSK Investigational Site
Frome, Somerset, United Kingdom, BA11 1EZ
GSK Investigational Site
Coventry, Warwickshire, United Kingdom, CV6 4DD
GSK Investigational Site
Trowbridge, Wiltshire, United Kingdom, BA14 9AR
GSK Investigational Site
Corsham, United Kingdom, SN13 8NA
GSK Investigational Site
Doncaster, United Kingdom, DN1 2EG
GSK Investigational Site
Ledbury, United Kingdom, HR8 2DX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00314860     History of Changes
Other Study ID Numbers: 101468/204
Study First Received: April 13, 2006
Last Updated: September 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Restless Legs Syndrome

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014