Ropinirole Tablets In Young Patients With Restless Legs Syndrome
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Restless Legs Syndrome
Intervention: Ropinirole Immediate Release (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: 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.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events.
Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy).
Secondary outcome: PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC.
PD - Leg movement as measured by actigraphy.
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Clinical Trials Call Center, Brussels 1020 Brussels, Belgium; Completed
GSK Clinical Trials Call Center, Paris 75019 Paris, France; Completed
GSK Clinical Trials Call Center, Washington, District of Columbia 20010, United States; Completed
GSK Clinical Trials Call Center, Chicago, Illinois 60611, United States; Recruiting
Phyllis Zee, Phone: 877-379-3718
GSK Clinical Trials Call Center, Louisville, Kentucky 40202, United States; Recruiting
Janice Sullivan, Phone: 877-379-3718
GSK Clinical Trials Call Center, Kansas City, Missouri 64108, United States; Recruiting
Gregory Kearns, Phone: 877-379-3718
GSK Clinical Trials Call Center, Edison, New Jersey 08818, United States; Completed
GSK Clinical Trials Call Center, Chapel Hill, North Carolina 27599-7220, United States; Completed
Additional Information
Starting date: November 2004
Last updated: August 5, 2008
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