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

Technische Universität Dresden

Status and phase

Completed

Phase 4

Conditions

Parkinson's Disease

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00307450

TUD-LELEDY-007

EUDRAC no.: 2005-005940-18

Ethic board no.: EK10012006

Details and patient eligibility

About

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.

Full 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

Enrollment

34 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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