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NCT Number: NCT00367822

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

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.

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IMEREM GmbH

Nuremberg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lisuride

Drug

Ropinirole

Drug

Placebo

Drug

Primary outcomes

  1. International Restless Legs Severity Scale (IRLS)

Secondary outcomes

  1. RLS-6 scales

  2. CGI

Sponsors and collaborators

Lead sponsor

Axxonis Pharma AG

Industry

Registry information

Official study 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)

Important dates

First posted
Aug 23, 2006
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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