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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Levetiracetam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|up to 200 mg per day in two dosages per day.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified AIMS |  | 11 weeks | 
| UPDRS items 32 & 33 |  | 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS |  | 11 weeks | 
| Schwab & England scale |  | 11 weeks | 
| Hoehn & Yahr scale |  | 11 weeks | 
| GCI |  | 11 weeks | 
| Patient day record |  | 11 weeks | 
| Epsworth sleep scale |  | 11 weeks | 
| Levodopa challenge test |  | 11 weeks | 
| Safety measures |  | 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyskinesias, Parkinson's disease, Levetiracetam, Treatment