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

NCT00291733 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2007-11-15

No results posted yet for this study

Summary

Levodopa-induced dyskinesias have been associated with irregular oscillatory discharge characteristics of basal ganglia. From the other hand, LEV which shares a different electrophysiologic profile than other antiepileptics, inhibits hyper-synchronization of abnormal neuronal firing in experimental models of epilepsy. LEV also reduces levodopa-induced dyskinesias in MPTP-lesioned macaques and modulates "priming phenomenon" which associated with long-term changes in synaptic function that can lead to dyskinesias in PD.

Study objectives :

* To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo on disabling dyskinesias that develop as result of long-term treatment with levodopa, occurring at the time of maximal clinical improvement in patients with Parkinson's disease (PD).
* To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.

Conditions

  • Levodopa Induced Dyskinesia

Interventions

DRUG

Levetiracetam

500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week

DRUG

Placebo

Placebo tabl

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • 1st Hospital of Social Security Services

    lead OTHER

Principal Investigators

  • Pantelis Stathis, MD · 1st Hospital of Social Security Services

  • Spiros Konitsiotis, MD · Department of Neurology, University of Ioannina

  • Vasilis Kyriakakis, MD · Department of Neurology, General Hospital of Lamia

  • Georgios Tagaris, MD · Department of Neurology, PGNA "Georgios Genimatas"

  • Kostas Papadopoulos, MD · Department of Neurology, Hospital of Mental Diseases of Tripolis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Completion
2007-10-31

Countries

  • Greece

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00291733 on ClinicalTrials.gov