Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS) - Tabular View

Tracking Information

First Received Date ^ICMJE

August 22, 2006

Last Updated Date

April 18, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

International Restless Legs Severity Scale (IRLS)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00367822 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

RLS-6 scales
CGI

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Official Title ^ICMJE

Transdermal Lisuride: a Double-Blind, Randomized, Active- and Placebo-Controlled Multi-Centre Phase III Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Brief Summary

The objective of this trial is to compare an individually optimized dose of the lisuride TTS patch against placebo and against an individually optimized dose of oral ropinirole (active- and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy, safety, and quality of life.

Detailed Description

Approximately 300 patients will be randomized to receive either lisuride, ropinirole or placebo in a 2:1:1 fashion. After completion of 12 weeks of double-blind treatment, eligible patients will have the option to continue treatment with the lisuride patch for further 36 weeks in an open-label extension of the study.

Primary outcome: Changes in the total score of the International Restless Legs Severity Scale (IRLS) from baseline to end of double-blind treatment (12 weeks) will be used as primary efficacy outcome measure.

Secondary objectives are to evaluate quality of life, safety and tolerability. After the double-blind period, long-term efficacy of lisuride will be assessed for further 36 weeks in an open-label extension of the study.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Restless Legs Syndrome

Intervention ^ICMJE

Drug: Lisuride
Drug: Ropinirole
Drug: Placebo

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

Active, not recruiting

Enrollment ^ICMJE

300

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Idiopathic or uremic RLS
RLS Diagnostic Index (RLS-DI) > 10
Total score in the IRLS Rating Scale ≥ 15 at baseline
No previous treatment for RLS or insufficient current therapy

Exclusion Criteria:

Secondary RLS, e.g. due to iron deficiency (exception: uremia)
History or presence of sleep disorders other than RLS

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00367822

Responsible Party

Study ID Numbers ^ICMJE

Tulir 03/01, EudraCT No.: 2005-003549-16

Study Sponsor ^ICMJE

Axxonis Pharma AG

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Heike Benes, MD

Somnibene GmbH

Information Provided By

Axxonis Pharma AG

Verification Date

March 2007

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