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

Condition(s) targeted: Restless Legs Syndrome

Intervention: Lisuride (Drug); Ropinirole (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Axxonis Pharma AG

Official(s) and/or principal investigator(s):
Heike Benes, MD, Principal Investigator, Affiliation: Somnibene GmbH

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.

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)

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

Primary outcome: International Restless Legs Severity Scale (IRLS)

Secondary outcome:

RLS-6 scales

CGI

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

IMEREM GmbH, Nuremberg, Germany

Last updated: April 18, 2007