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Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys)

This study has been completed.
Sponsor:
Collaborator:
UCB GmbH, Huettenstrasse 205, 50170 Kerpen, Germany
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00307450
First received: March 27, 2006
Last updated: July 31, 2009
Last verified: July 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • Modified AIMS [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • UPDRS items 32 & 33 [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • UPDRS [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Schwab & England scale [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Hoehn & Yahr scale [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • GCI [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Patient day record [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Epsworth sleep scale [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
  • Levodopa challenge test [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Safety measures [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 34
Study Start Date: March 2006
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Levetiracetam
    up to 200 mg per day in two dosages per day.
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 multicenter, 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

Locations
Germany
Department of Neurology at the Technical University of Dresden
Dresden, Germany, 01307
Department of Neurology at the University of Leipzig
Leipzig, Germany, 04103
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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Prof. Dr. med. Alexander Storch, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00307450     History of Changes
Other Study ID Numbers: TUD-LELEDY-007, Ethic board no.: EK10012006, EUDRAC no.: 2005-005940-18
Study First Received: March 27, 2006
Last Updated: July 31, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:
Dyskinesias
Parkinson's disease
Levetiracetam
Treatment

Additional relevant MeSH terms:
Dyskinesias
Parkinson Disease
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases
Levodopa
Etiracetam
Piracetam
 Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013