Ropinirole Tablets In Young Patients With Restless Legs Syndrome

Completed · Phase 1

Conditions studied: Restless Legs Syndrome

In brief

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.

Key facts

Study ID

NCT00140712

Run by

GlaxoSmithKline

People needed

9

Starts

2005-06-10

Expected to finish

2008-02-28

Last updated by the study team

2017-09-11

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Macon, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — Edison, New Jersey, United States
• GSK Investigational Site — Chapel Hill, North Carolina, United States
• GSK Investigational Site — Brussels, Belgium
• GSK Investigational Site — Paris, France

Full record on ClinicalTrials.gov

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