Ropinirole Tablets In Young Patients With Restless Legs Syndrome



Status:Completed
Conditions:Restless Leg Syndrome, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:12 - 17
Updated:4/21/2016
Start Date:June 2005
End Date:December 2007

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An Open Label, Single Dose, Dose Rising, Multi-centre Study to Assess the Tolerability and Pharmacokinetics of Ropinirole Immediate Release in Adolescent Patients With RLS.

This is a two-period dose rising study of Ropinirole Immediate Release in adolescent
patients with restless legs syndrome (RLS) in order to determine the starting dose for the
ropinirole titration regimen for this age group. Patients will receive two single doses
unless poor tolerability is observed following the first dose.


Inclusion Criteria:

- Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).

Exclusion Criteria:

- Subjects who require RLS treatment during the daytime, suffer from other primary
sleep disorders or are taking medication known to induce drowsiness, affect RLS or
sleep, or to induce or treat alertness, including methylphenidate.
We found this trial at
8
sites
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Bruxelles,
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Chicago, Illinois 60611
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Chicago, IL
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Edison, New Jersey
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Edison, NJ
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Kansas City, Missouri 64128
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Kansas City, MO
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Louisville, Kentucky 40202
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Louisville, KY
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Macon, Georgia 31201
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Macon, GA
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Washington, District of Columbia 20007
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Washington,
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