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Prevention of Post-traumatic Seizures With Levetiracetam

Information source: Rennes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy, Post-Traumatic

Intervention: Levetiracetam (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Rennes University Hospital

Official(s) and/or principal investigator(s):
Arnaud Biraben, MD, Principal Investigator, Affiliation: Rennes University Hospital
Bruno Laviolle, MD, Study Chair, Affiliation: Rennes University Hospital

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

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

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

Global prognosis (Glasgow Outcome Scale)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Neurologie - CHU Angers, Angers, France

Neurology - CHU Bordeaux, Bordeaux, France

Neurologie - CHU Caen, Caen, France

Neurochirurgie-CHU Grenoble, Grenoble, France

Neurology - CHU Rennes, Grenoble, France

Neurophysiologie Clinique - CHU Lille, Lille, France

Neurophysiologie clinique - CHU Lyon (Hôpital neurologique), Lyon, France

Beurophysiologie clinique - CHU Marseille, Marseille, France

Epileptologie - CHU Montpellier, Montpellier, France

Neurologie - CHU Nancy, Nancy, France

Neurochirurgie-Paris Saint Anne, Paris 75674, France

Explorations Fonctionnelles Neurologiques - CHU Nantes, Rennes, France

Neurologie - CHU Rennes, Rennes 35000, France

Neurologie - CHU Rouen, Rouen, France

Neurologie - CHU Tours Hopital Trousseau, Tours, France

Additional Information

Starting date: November 2007
Last updated: June 20, 2012

Page last updated: August 23, 2015

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