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