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

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ClinicalTrials.gov Identifier: NCT00367822
Recruitment Status : Completed
First Posted : August 23, 2006
Last Update Posted : March 7, 2012
Sponsor:
Information provided by:
Axxonis Pharma AG

Brief 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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Lisuride Drug: Ropinirole Drug: Placebo Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Ropinirole
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. RLS-6 scales
  2. CGI


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367822


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

ClinicalTrials.gov Identifier: NCT00367822     History of Changes
Other Study ID Numbers: Tulir 03/01
EudraCT No.: 2005-003549-16
First Posted: August 23, 2006    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: January 2010

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

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