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
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.