Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome) - Tabular View

Tracking Information

First Received Date ^ICMJE

November 21, 2005

Last Updated Date

May 15, 2009

Start Date ^ICMJE

November 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

adverse events (AE) post-conversion from ropinirole IR to ropinirole controlled-release for RLS

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00256854 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion discontinuing drug due to AEs after conversion from ropinirole IR to ropinirole controlled-release for RLS, analyses of AEs and vital signs, efficacy parameters(International RLS (IRLS) Rating Scale)

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

Official Title ^ICMJE

A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting From Ropinirole Immediate Release (IR) to Ropinirole Extended Release (XR) Formulation in Patients With Restless Legs Syndrome (RLS)

Brief Summary

This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Restless Legs Syndrome (RLS)

Intervention ^ICMJE

Drug: ropinirole controlled-release for RLS

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

Enrollment ^ICMJE

150

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.
Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.
Subjects with RLS symptoms during both the evening and night or night time only.
Subjects who have given written informed consent to participate.

Exclusion Criteria:

Subjects who require treatment of daytime RLS symptoms.
Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
Movement Disorders, Clinically significant or unstable medical conditions.
Abnormal labs, electrocardiogram (ECG) or physical findings.
Receiving prohibited medications.
Sleeping habits incompatible with study design.
Intolerance to ropinirole or other dopamine agonist.
Pregnant or lactating.
Women of child-bearing potential who are not practicing an acceptable method of birth control.

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00256854

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

ROX104805

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

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