Ropinirole Tablets In Young Patients With Restless Legs Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

June 4, 2009

Start Date ^ICMJE

June 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00140712 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Ropinirole Tablets In Young Patients With Restless Legs Syndrome

Official Title ^ICMJE

An Open Label, Single Dose, Dose Rising, Multi-Centre Study to Assess the Tolerability and Pharmacokinetics of Ropinirole Immediate Release in Adolescent Patients With RLS.

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Restless Legs Syndrome (RLS)

Intervention ^ICMJE

Drug: Ropinirole Immediate Release

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, France

Administrative Information

NCT ID ^ICMJE

NCT00140712

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

101468/253, SK&F101468/253

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP