Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
|Restless Legs Syndrome||Drug: Lisuride Drug: Ropinirole Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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)|
- International Restless Legs Severity Scale (IRLS)
- RLS-6 scales
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367822
|Principal Investigator:||Heike Benes, MD||Somnibene GmbH|