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

Restless Legs Syndrome Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367822
• Other study ID #: Tulir 03/01
• Secondary ID: EudraCT No.: 200
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2006
• Last updated: March 6, 2012

Study information

• Verified date: January 2010
• Source: Axxonis Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Lisuride

• Ropinirole

• Placebo

Locations

Country	Name	City	State
Germany	IMEREM GmbH	Nuremberg

Sponsors (1)

Lead Sponsor	Collaborator
Axxonis Pharma AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Restless Legs Severity Scale (IRLS)
Secondary	RLS-6 scales
Secondary	CGI