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

This study has been completed.
Sponsor:
Information provided by:
Axxonis Pharma AG
ClinicalTrials.gov Identifier:
NCT00367822
First received: August 22, 2006
Last updated: March 6, 2012
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Restless Legs Syndrome
Drug: Lisuride
Drug: Ropinirole
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Axxonis Pharma AG:

Primary Outcome Measures:
  • International Restless Legs Severity Scale (IRLS)

Secondary Outcome Measures:
  • RLS-6 scales
  • CGI

Estimated Enrollment: 300
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367822

Locations
Germany
IMEREM GmbH
Nuremberg, Germany
Sponsors and Collaborators
Axxonis Pharma AG
Investigators
Principal Investigator: Heike Benes, MD Somnibene GmbH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00367822     History of Changes
Other Study ID Numbers: Tulir 03/01, EudraCT No.: 2005-003549-16
Study First Received: August 22, 2006
Last Updated: March 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Axxonis Pharma AG:
Restless Legs Syndrome
dopamine agonist
lisuride
ropinirole

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Lisuride
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 23, 2014