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Prevention of Post-traumatic Seizures With Levetiracetam

NCT00566046 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-06-21

No results posted yet for this study

Summary

Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two types of seizures are usually identified: early seizures during the week following the trauma and late epilepsy afterward. Several antiepileptic drugs are usually used to prevent early seizures but no treatment has demonstrated any preventive effect against late epilepsy. Levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients and has pharmacologic properties that could also be interesting for the prevention of post-traumatic epilepsy.

Conditions

  • Epilepsy, Post-Traumatic

Interventions

DRUG

Levetiracetam

1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months

DRUG

Placebo

1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Arnaud Biraben, MD · Rennes University Hospital

  • Bruno Laviolle, MD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-12-31
Completion
2010-05-31

Countries

  • France

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 NCT00566046 on ClinicalTrials.gov