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Ropinirole Tablets In Young Patients With Restless Legs Syndrome

GlaxoSmithKline (GSK) logo

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)

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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