Trial | NCT00367822  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    300
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.
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.
Study Started
Aug 22
2006
Last Update
Mar 07
2012
Estimate

Drug Lisuride

Drug Ropinirole

Drug Placebo

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
No Results Posted