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

July 31, 2009 updated by: Technische Universität Dresden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified AIMS
Time Frame: 11 weeks
11 weeks
UPDRS items 32 & 33
Time Frame: 11 weeks
11 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
UPDRS
Time Frame: 11 weeks
11 weeks
Schwab & England scale
Time Frame: 11 weeks
11 weeks
Hoehn & Yahr scale
Time Frame: 11 weeks
11 weeks
GCI
Time Frame: 11 weeks
11 weeks
Patient day record
Time Frame: 11 weeks
11 weeks
Epsworth sleep scale
Time Frame: 11 weeks
11 weeks
Levodopa challenge test
Time Frame: 11 weeks
11 weeks
Safety measures
Time Frame: 11 weeks
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

UCB Pharma GmbH

Investigators

  • Principal Investigator: Alexander Storch, M, Technical University of Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

August 3, 2009

Last Update Submitted That Met QC Criteria

July 31, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD-LELEDY-007
  • Ethic board no.: EK10012006
  • EUDRAC no.: 2005-005940-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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