Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-Induced Dyskinesias in Advanced Parkinson's Disease - Full Text View

Sponsors and Collaborators:	Dresden University of Technology UCB GmbH, Huettenstrasse 205, 50170 Kerpen, Germany
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00307450

Purpose

The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Levetiracetam	Phase IV

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levetiracetam Levodopa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-Induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Monocenter, Randomized, Stratified, Double-Blinded, Placebo-Controlled Phase IV Study

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Modified AIMS

Secondary Outcome Measures:

UPDRS
Schwab & England scale
Hoehn & Yahr scale
GCI
Patient day record
Epsworth sleep scale
Levodopa challenge test
Safety measures

Estimated Enrollment:	44
Study Start Date:	March 2006
Estimated Study Completion Date:	August 2008

Detailed Description:

The LeLeDys study is designed to determine the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in advanced Parkinson's disease.

The design is a monocenter, randomized, stratified, double-blinded, placebo-controlled phase IV study design.

The hypothesis is that levetiracetam is able to reduce duration and severity of levodopa-induced dyskinesias in Parkinson's disease.

The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.

Main inclusion criteria are:

Advanced Parkinson's disease (Hoehn & Yahr II-IV)
Age of 30 to 80 years
Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
Written informed consent

Main exclusion criteria are:

Atypical parkinsonian syndromes
Treatment with antipsychotics
Epilepsia or seizure in the history
Deep brain stimulation other than DBS in STN
Pregnant or lactating women
Severe dementia

Methods:

Primary outcome measure is the modified AIMS
Secondary outcome measures include UPDRS, safety, patient day record

Study medication:

Levetiracetam (upt to 2000 mg / day)
Matched Placebo

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced Parkinson's disease (Hoehn & Yahr II-IV)
Age of 30 to 80 years
Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
Written informed consent

Exclusion Criteria:

Atypical parkinsonian syndromes
Treatment with antipsychotics
Epilepsia or seizure in the history
Deep brain stimulation other than DBS in STN
Pregnant or lactating women
Severe dementia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307450

Contacts

Contact: Alexander Storch, MD	++49-351-458 ext 2532	alexander.storch@neuro.med.tu-dresden.de
Contact: Martin Wolz, MD	++49-351-458 ext 3886	martin.wolz@neuro.med.tu-dresden.de

Locations

Germany
Department of Neurology at the Technical University of Dresden	Recruiting
Dresden, Germany, 01307
Contact: Alexander Storch, MD ++49-351-458 ext 2532^ alexander.storch@neuro.med.tu-dresden.de
Contact: Martin Wolz, MD ++49-351-458 ext 3886 martin.wolz@neuro.med.tu-dresden.de
Sub-Investigator: Martin Wolz, MD

Sponsors and Collaborators

Dresden University of Technology

UCB GmbH, Huettenstrasse 205, 50170 Kerpen, Germany

Investigators

Principal Investigator:

Alexander Storch, M

Technical University of Dresden

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	TUD-LELEDY-007, Ethic board no.: EK10012006, EUDRAC no.: 2005-005940-18
Study First Received:	March 27, 2006
Last Updated:	April 4, 2007
ClinicalTrials.gov Identifier:	NCT00307450
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

Dyskinesias
Parkinson's disease
Levetiracetam
Treatment

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias

Signs and Symptoms
Parkinson Disease
Movement Disorders
Piracetam
Neurologic Manifestations
Etiracetam
Parkinsonian Disorders

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents

Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009