RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
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)
1 other identifier
interventional
568
12 countries
89
Brief Summary
Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2006
Shorter than P25 for phase_3
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 13, 2006
CompletedFirst Posted
Study publicly available on registry
April 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedOctober 18, 2016
October 1, 2016
10 months
April 13, 2006
October 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 Weeks
Secondary Outcomes (1)
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.
12 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (91)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Mesa, Arizona, 85210, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Sun City, Arizona, 85351, United States
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Anaheim, California, 92801, United States
GSK Investigational Site
Burlingame, California, 94010, United States
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Long Beach, California, 90806, United States
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Newport Beach, California, 92660, United States
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Pasadena, California, 91106, United States
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Redondo Beach, California, 90277, United States
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Santa Monica, California, 90404, United States
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Stanford, California, 94305-5548, United States
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Winnetka, California, 91306, United States
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Boca Raton, Florida, 33486, United States
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Coeur d'Alene, Idaho, 83814, United States
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Springfield, Massachusetts, 01104, United States
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West Yarmouth, Massachusetts, 02673, United States
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Worcester, Massachusetts, 01655, United States
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Kalamazoo, Michigan, 49048, United States
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Saint Paul, Minnesota, 55101, United States
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St Louis, Missouri, 63128, United States
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Las Vegas, Nevada, 89119, United States
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Albany, New York, 12205, United States
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Tabor City, North Carolina, 28463, United States
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Fargo, North Dakota, 58104, United States
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Oklahoma City, Oklahoma, 73104, United States
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Warwick, Rhode Island, 02886, United States
GSK Investigational Site
Burlington, Vermont, 05401, United States
GSK Investigational Site
Camperdown, New South Wales, 2050, Australia
GSK Investigational Site
Auchenflower, Queensland, 4066, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Innsbruck, A-6020, Austria
GSK Investigational Site
Vienna, A-1090, Austria
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Brussels, 1190, Belgium
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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Liège, 4000, Belgium
GSK Investigational Site
Glostrup Municipality, 2600, Denmark
GSK Investigational Site
Hvidovre, 2650, Denmark
GSK Investigational Site
Koebenhavn NV, 2300, Denmark
GSK Investigational Site
Odense C, DK-5000, Denmark
GSK Investigational Site
Anzin, 59410, France
GSK Investigational Site
Bordeaux, 33000, France
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Bron, 69677, France
GSK Investigational Site
Créteil, 94010, France
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Grenoble, 38043, France
GSK Investigational Site
Lille, 59037, France
GSK Investigational Site
Montbrison, 42600, France
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Nancy, 54035, France
GSK Investigational Site
Pessac, 33604, France
GSK Investigational Site
Munich, Bavaria, 80331, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19053, Germany
GSK Investigational Site
Chemnitz, Saxony, 09111, Germany
GSK Investigational Site
Köthen, Saxony-Anhalt, 06366, Germany
GSK Investigational Site
Berlin, State of Berlin, 12163, Germany
GSK Investigational Site
Gera, Thuringia, 07551, Germany
GSK Investigational Site
Bologna, Emilia-Romagna, 40123, Italy
GSK Investigational Site
Rome, Lazio, 00168, Italy
GSK Investigational Site
Milan, Lombardy, 20127, Italy
GSK Investigational Site
Pavia, Lombardy, 27100, Italy
GSK Investigational Site
Pisa, Tuscany, 56126, Italy
GSK Investigational Site
Amsterdam, 1066 EC, Netherlands
GSK Investigational Site
Geldermalsen, 4191 AH, Netherlands
GSK Investigational Site
Grubbenvorst, 5971 BB, Netherlands
GSK Investigational Site
Hoogwoud, 1718 BG, Netherlands
GSK Investigational Site
Nieuwegein, 3435 CM, Netherlands
GSK Investigational Site
Roelofarendsveen, 2371 RB, Netherlands
GSK Investigational Site
Zwolle, 8025 BV, Netherlands
GSK Investigational Site
Bergen, 5094, Norway
GSK Investigational Site
Oslo, 0277, Norway
GSK Investigational Site
Sandvika, N-1338, Norway
GSK Investigational Site
Barcelona, 08017, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Granada, 18013, Spain
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Madrid, 28036, Spain
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Palma de Mallorca, 07014, Spain
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San Sebastián, 20014, Spain
GSK Investigational Site
Zaragoza, 50009, Spain
GSK Investigational Site
Gothenburg, SE-412 55, Sweden
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Helsingborg, SE-252 21, Sweden
GSK Investigational Site
Örebro, 701 85, Sweden
GSK Investigational Site
Chesterfield, Derbyshire, S40 4TF, United Kingdom
GSK Investigational Site
Blackpool, Lancashire, FY4 3AD, United Kingdom
GSK Investigational Site
Frome, Somerset, BA11 1EZ, United Kingdom
GSK Investigational Site
Coventry, Warwickshire, CV6 4DD, United Kingdom
GSK Investigational Site
Trowbridge, Wiltshire, BA14 9AR, United Kingdom
GSK Investigational Site
Corsham, SN13 8NA, United Kingdom
GSK Investigational Site
Doncaster, DN1 2EG, United Kingdom
GSK Investigational Site
Ledbury, HR8 2DX, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2006
First Posted
April 17, 2006
Study Start
February 1, 2006
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
October 18, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.