Ropinirole Tablets In Young Patients With Restless Legs Syndrome

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Restless Legs Syndrome

Treatments: Drug: Ropinirole Immediate Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00140712

101468/253

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Ropinirole

Experimental group

Description:

single dose .25mg of IR formulation, .05mg of RLS controlled release

Treatment:

Drug: Ropinirole Immediate Release