Prevention of Post-traumatic Seizures With Levetiracetam (TRACK)

Rennes University Hospital

Status and phase: Terminated; Phase 3

Conditions: Epilepsy, Post-Traumatic

Treatments: Drug: Levetiracetam; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00566046

CIC0203/60 (Other Identifier)

EudraCT: 2006-006518-13

LOC/06-06 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups, including a placebo group

Levetiracetam

Experimental group

Treatment:

Drug: Levetiracetam

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo