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

Primary Purpose

Restless Legs Syndrome, Restless Legs Syndrome (RLS)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ropinirole Extended Release (XR)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Restless Legs Syndrome

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
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Outcomes

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

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.

Full Information

First Posted
April 13, 2006
Last Updated
October 17, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00314860
Brief Title
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome, Restless Legs Syndrome (RLS)
Keywords
Restless Legs Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
568 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ropinirole Extended Release (XR)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/204
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/204
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/204
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/204
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/204
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/204
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/204
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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