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

Phase 4

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00307450
• Lead Sponsor: Technische Universität Dresden

Brief 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

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-28
• Primary Completion: 2009-03
• Status Verified: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-31
• Last Update Posted: 2009-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Modified AIMS	11 weeks
UPDRS items 32 & 33	11 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Department of Neurology at the Technical University of Dresden; 🇩🇪 Dresden, Germany

Department of Neurology at the University of Leipzig; 🇩🇪 Leipzig, Germany