Status:
COMPLETED
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
UCB Pharma GmbH
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
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 (...
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, stratifie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00307450
Start Date
March 1 2006
End Date
July 1 2009
Last Update
August 3 2009
Active Locations (2)
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1
Department of Neurology at the Technical University of Dresden
Dresden, Germany, 01307
2
Department of Neurology at the University of Leipzig
Leipzig, Germany, 04103