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

Restless Legs Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314860
• Other study ID #: 101468/204
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2006
• Last updated: October 17, 2016
• Start date: February 2006
• Est. completion date: December 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Restless Legs Syndrome (RLS)
• Syndrome

Intervention

Drug:
• ropinirole Extended Release (XR)

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Auchenflower	Queensland
Australia	GSK Investigational Site	Camperdown	New South Wales
Australia	GSK Investigational Site	Kippa Ring	Queensland
Austria	GSK Investigational Site	Innsbruck
Austria	GSK Investigational Site	Vienna
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Charleroi
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Liege
Belgium	GSK Investigational Site	Liège
Denmark	GSK Investigational Site	Glostrup
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	Koebenhavn NV
Denmark	GSK Investigational Site	Odense C
France	GSK Investigational Site	Anzin
France	GSK Investigational Site	Bordeaux
France	GSK Investigational Site	Bron Cedex
France	GSK Investigational Site	Créteil
France	GSK Investigational Site	Grenoble Cedex 09
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Montbrison
France	GSK Investigational Site	Nancy Cedex
France	GSK Investigational Site	Pessac Cedex
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Gera	Thueringen
Germany	GSK Investigational Site	Koethen	Sachsen-Anhalt
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Pavia	Lombardia
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Roma	Lazio
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Geldermalsen
Netherlands	GSK Investigational Site	Grubbenvorst
Netherlands	GSK Investigational Site	Hoogwoud
Netherlands	GSK Investigational Site	Nieuwegein
Netherlands	GSK Investigational Site	Roelofarendsveen
Netherlands	GSK Investigational Site	Zwolle
Norway	GSK Investigational Site	Bergen
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Sandvika
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	San Sebastián
Spain	GSK Investigational Site	Zaragoza
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Helsingborg
Sweden	GSK Investigational Site	Örebro
United Kingdom	GSK Investigational Site	Blackpool	Lancashire
United Kingdom	GSK Investigational Site	Chesterfield	Derbyshire
United Kingdom	GSK Investigational Site	Corsham
United Kingdom	GSK Investigational Site	Coventry	Warwickshire
United Kingdom	GSK Investigational Site	Doncaster
United Kingdom	GSK Investigational Site	Frome	Somerset
United Kingdom	GSK Investigational Site	Ledbury
United Kingdom	GSK Investigational Site	Trowbridge	Wiltshire
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boca Raton	Florida
United States	GSK Investigational Site	Burlingame	California
United States	GSK Investigational Site	Burlington	Vermont
United States	GSK Investigational Site	Coeur D'Alene	Idaho
United States	GSK Investigational Site	Fargo	North Dakota
United States	GSK Investigational Site	Kalamazoo	Michigan
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Pasadena	California
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Redondo Beach	California
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Paul	Minnesota
United States	GSK Investigational Site	Stanford	California
United States	GSK Investigational Site	Sun City	Arizona
United States	GSK Investigational Site	Tabor City	North Carolina
United States	GSK Investigational Site	Warwick	Rhode Island
United States	GSK Investigational Site	West Yarmouth	Massachusetts
United States	GSK Investigational Site	Winnetka	California
United States	GSK Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Denmark,  France,  Germany,  Italy,  Netherlands,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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