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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Levetiracetam Treatment of L-dopa Induced Dyskinesias

NCT00076674

Dyskinesias Parkinson Disease

COMPLETED PHASE2

Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease

NCT00291733

Levodopa Induced Dyskinesia

UNKNOWN PHASE2

Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

NCT00175955

Dyskinesia, Medication-induced

COMPLETED PHASE2

Levetiracetam Treatment of Tardive Dyskinesia

NCT00291213

Tardive Dyskinesia

COMPLETED PHASE3

Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease

NCT04643327

Parkinson Disease Mild Cognitive Impairment Memory Impairment

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levetiracetam

up to 200 mg per day in two dosages per day.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No