NCT00566046

Prevention of Post-traumatic Seizures With Levetiracetam

Prospective, Randomized, Double-blind Study Assessing the Effects of Levetiracetam Compared to Placebo in the Prevention of Early Epileptic Seizures and Late Epilepsy in Patients With Severe Traumatic Brain Injury

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-12-01
• Completion: 2010-05-01
• First posted: 2007-11-30
• Last updated: 2012-06-21

Locations

15 sites across 1 country: France