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

Sponsor:	Axxonis Pharma AG
Information provided by:	Axxonis Pharma AG
ClinicalTrials.gov Identifier:	NCT00367822

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Restless Legs

Drug Information available for: Lisuride Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

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

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

Study ID Numbers:	Tulir 03/01, EudraCT No.: 2005-003549-16
Study First Received:	August 22, 2006
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00367822 History of Changes
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:

Serotonin Agonists
Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Sleep Disorders
Antiparkinson Agents
Psychomotor Agitation
Dopamine Agonists
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Syndrome

Therapeutic Uses
Restless Legs Syndrome
Psychomotor Disorders
Neurobehavioral Manifestations
Disease
Parasomnias
Nervous System Diseases
Dyssomnias
Dyskinesias
Pharmacologic Actions
Serotonin Agents
Neurologic Manifestations
Dopamine Agents
Lisuride
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009