Clinical trial NCT00307450: Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Dyskinesias
Parkinson's disease
Levetiracetam
Treatment
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: UCB Pharma GmbH
First posted: 2006-03-28
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Modified AIMS
timeFrame: 11 weeks
measure: UPDRS items 32 & 33
timeFrame: 11 weeks
Secondary outcomes:
measure: UPDRS
timeFrame: 11 weeks
measure: Schwab & England scale
timeFrame: 11 weeks
measure: Hoehn & Yahr scale
timeFrame: 11 weeks
measure: GCI
timeFrame: 11 weeks
measure: Patient day record
timeFrame: 11 weeks
measure: Epsworth sleep scale
timeFrame: 11 weeks
measure: Levodopa challenge test
timeFrame: 11 weeks
measure: Safety measures
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Neurology at the Technical University of Dresden
city: Leipzig
country: Germany
facility: Department of Neurology at the University of Leipzig
Study officials:
affiliation: Technical University of Dresden
name: Alexander Storch, M
role: PRINCIPAL_INVESTIGATOR
References: