Ropinirole Tablets In Young Patients With Restless Legs Syndrome

Phase 1

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Ropinirole Immediate Release

• Registration Number: NCT00140712
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-10
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-01
• Primary Completion: 2008-02-28
• Study Completion: 2008-02-28
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ropinirole	Ropinirole Immediate Release	single dose .25mg of IR formulation, .05mg of RLS controlled release

Primary Outcome Measures

Name	Time	Method
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).	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy.	Up to 3 years

Trial Locations

Locations (1)

GSK Investigational Site; 🇫🇷 Paris, France