Efficacy & Safety of Levetiracetam Versus Placebo on Levodopa-induced

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00307450
Study type	Interventional
Source	Technische Universität Dresden
Contact
Status	Completed
Phase	Phase 4
Start date	March 2006
Completion date	July 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms