Ropinirole Tablets In Young Patients With Restless Legs Syndrome

Restless Legs Syndrome Clinical Trial

Official title:

A Study to Determine the Tolerability and Pharmacokinetics for Ropinirole in Paediatric / Adolescent Patients With RLS (Type 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140712
• Other study ID #: 101468/253
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2005
• Last updated: September 8, 2017
• Start date: June 10, 2005
• Est. completion date: February 28, 2008

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 28, 2008
• Est. primary completion date: February 28, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Ropinirole Immediate Release
Ropinirole Immediate Release

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bruxelles
France	GSK Investigational Site	Paris
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Edison	New Jersey
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Macon	Georgia
United States	GSK Investigational Site	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 101468/253 can be found on the GSK Clinical Study Register.