Clinical Trial: Prevention of Post-traumatic Seizures With Levetiracetam
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 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
Brief 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.
Detailed Summary:
Sponsor: Rennes University Hospital
Current Primary Outcome: Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to 1 year) in patients with severe traumatic brain injury [ Time Frame: one year ]
Original Primary Outcome: Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to one year) in patients with severe traumatic brain injury [ Time Frame: one year ]
Current Secondary Outcome:
- Rate of early seizures and of late epilepsy; treatment effects according to the patient's severity, the TDM US Traumatic Coma Data Bank, and the number of regions traumatized; safety of Levetiracetam [ Time Frame: One year ]
- Global prognosis (Glasgow Outcome Scale) [ Time Frame: 3 months, 6 months and 1 year ]
Original Secondary Outcome: Rate of early seizures and of late epilepsy; treatment effects according to the patient's severity, the TDM US Traumatic Coma Data Bank, and the number of regions traumatized; global prognosis (Glasgow Outcome Scale); safety of Levetiracetam [ Time Frame: One year ]
Information By: Rennes University Hospital
Dates:
Date Received: November 29, 2007
Date Started: November 2007
Date Completion:
Last Updated: June 20, 2012
Last Verified: June 2012
