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 scalesCGI
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
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