Clinical trial NCT00566046: Prevention of Post-traumatic Seizures With Levetiracetam
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 Brain Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epilepsy, Post-Traumatic
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2007-11-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Age \>= 18 years old
2. Patient with severe brain injury defined as follow:

   * Initial Glasgow Coma score (assessed on the scene of the accident) \<= 8 related to the brain injury
   * Stage 2 to 4 on the TDM US TCDB classification
3. Initial brain CT scan performed within 48 hours after hospital admission
4. Either a male or a nonpregnant, non-lactating female who is using adequate contraceptive method (a urine laboratory pregnancy test must be negative at baseline)
5. Written informed consent from the patient's next-of-kin. If no relative is present as the time of inclusion, the patients will be included according to the emergency procedure

Exclusion Criteria:

1. Isolated extradural hematoma
2. Medical decision to limit patient's care (terminal stage of a cancer, hematological malignancies, HIV, etc.)
3. Current participation in an other protocol or within one month before study entry
4. Previous treatment with Levetiracetam
5. Patient's follow-up judged to be difficult by the investigator
6. Known allergy to either Levetiracetam or products derived from pyrrolidone or one of its excipients
7. Epileptic patient treated or not (except patients treated with benzodiazepines who can be included in this protocol)

Primary outcomes:
measure: Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to 1 year) in patients with severe traumatic brain injury
timeFrame: one year
Secondary outcomes:
measure: 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
timeFrame: One year
measure: Global prognosis (Glasgow Outcome Scale)
timeFrame: 3 months, 6 months and 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: Neurologie - CHU Angers
city: Bordeaux
country: France
facility: Neurology - CHU Bordeaux
city: Caen
country: France
facility: Neurologie - CHU Caen
city: Grenoble
country: France
facility: Neurochirurgie-CHU Grenoble
city: Grenoble
country: France
facility: Neurology - CHU Rennes
city: Lille
country: France
facility: Neurophysiologie Clinique - CHU Lille
city: Lyon
country: France
facility: Neurophysiologie clinique - CHU Lyon (Hôpital neurologique)
city: Marseille
country: France
facility: Beurophysiologie clinique - CHU Marseille
city: Montpellier
country: France
facility: Epileptologie - CHU Montpellier
city: Nancy
country: France
facility: Neurologie - CHU Nancy
city: Paris
country: France
facility: Neurochirurgie-Paris Saint Anne
city: Rennes
country: France
facility: Neurologie - CHU Rennes
city: Rennes
country: France
facility: Explorations Fonctionnelles Neurologiques - CHU Nantes
city: Rouen
country: France
facility: Neurologie - CHU Rouen
city: Tours
country: France
facility: Neurologie - CHU Tours Hopital Trousseau
Study officials:
affiliation: Rennes University Hospital
name: Arnaud Biraben, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Bruno Laviolle, MD
role: STUDY_CHAIR
References: