NCT00307450

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 (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Levetiracetam	up to 200 mg per day in two dosages per day.

Timeline

• Start date: 2006-03-01
• Primary completion: 2009-03-01
• Completion: 2009-07-01
• First posted: 2006-03-28
• Last updated: 2009-08-03

Locations

2 sites across 1 country: Germany