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

Information source: Axxonis Pharma AG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Restless Legs Syndrome

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

Phase: Phase 3

Status: Completed

Sponsored by: Axxonis Pharma AG

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

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.

Clinical Details

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

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.

Eligibility

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

Locations and Contacts

IMEREM GmbH, Nuremberg, Germany
Additional Information


Last updated: March 6, 2012

Page last updated: August 23, 2015

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