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



Status:Completed
Conditions:Restless Leg Syndrome, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:18 - 79
Updated:10/14/2017
Start Date:February 2006
End Date:December 2006

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Trial Summary
Trial Overview
Inclusion Criteria

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)

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


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.
We found this trial at
29
sites
GSK Investigational Site
Warwick, Rhode Island 02888
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Warwick, RI
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Albany, New York 12206
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Albany, NY
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Anaheim, California 92807
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Anaheim, CA
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Birmingham, Alabama 35249
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Birmingham, AL
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Boca Raton, Florida 33486
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Boca Raton, FL
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Burlingame, California 94010
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Burlingame, CA
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Burlington, Vermont 05401
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Burlington, VT
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Camperdown, New South Wales 2050
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Camperdown,
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Coeur d'Alene, Idaho 83814
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Coeur d'Alene, ID
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Fargo, North Dakota 58122
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Fargo, ND
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GSK Investigational Site
Kalamazoo, Michigan 49007
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Kalamazoo, MI
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GSK Investigational Site
Las Vegas, Nevada 89102
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Las Vegas, NV
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GSK Investigational Site
Long Beach, California 90813
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Long Beach, CA
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GSK Investigational Site
Mesa, Arizona 85206
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Mesa, AZ
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Newport Beach, California 92663
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Newport Beach, CA
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GSK Investigational Site
Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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GSK Investigational Site
Pasadena, California 91105
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Pasadena, CA
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Phoenix, Arizona 85012
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Phoenix, AZ
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Redondo Beach, California 90277
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Redondo Beach, CA
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GSK Investigational Site
Santa Monica, California 90404
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Santa Monica, CA
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Springfield, Massachusetts 01199
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Springfield, MA
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St. Louis, Missouri 63110
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St. Louis, MO
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St. Paul, Minnesota 55102
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St. Paul, MN
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Stanford, California 94305
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Stanford, CA
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Sun City, Arizona 85351
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Sun City, AZ
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GSK Investigational Site
Tabor City, North Carolina 28463
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Tabor City, NC
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GSK Investigational Site
West Yarmouth, Massachusetts 02673
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West Yarmouth, MA
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GSK Investigational Site
Winnetka, California 91306
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Winnetka, CA
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GSK Investigational Site
Worcester, Massachusetts 01655
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Worcester, MA
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