Ropinirole Tablets In Young Patients With Restless Legs Syndrome

GlaxoSmithKline9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Restless Legs Syndrome

Interventions

Ropinirole Immediate ReleaseDRUG

Ropinirole Immediate Release

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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 (9)

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

Outcomes

Primary Outcomes

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).

Time frame: Up to 3 years

Secondary Outcomes

PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy.

Time frame: Up to 3 years

Data from ClinicalTrials.gov

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