Overview

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

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
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 (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Technische Universität Dresden
Collaborator:
UCB Pharma GmbH
Treatments:
Etiracetam
Levetiracetam
Levodopa
Piracetam
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