Prevention of Post-traumatic Seizures With Levetiracetam

Epilepsy, Post-Traumatic Clinical Trial

— TRACK  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00566046
• Other study ID #: EudraCT: 2006-006518-13
• Secondary ID: CIC0203/60LOC/06
• Status: Terminated
• Phase: Phase 3
• First received: November 29, 2007
• Last updated: June 20, 2012
• Start date: November 2007
• Est. completion date: May 2010

Study information

• Verified date: June 2012
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Post-Traumatic

Intervention

Drug:
• Levetiracetam
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
• Placebo
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months

Locations

Country	Name	City	State
France	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
France	Explorations Fonctionnelles Neurologiques - CHU Nantes	Rennes
France	Neurologie - CHU Rennes	Rennes
France	Neurologie - CHU Rouen	Rouen
France	Neurologie - CHU Tours Hopital Trousseau	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	UCB Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to 1 year) in patients with severe traumatic brain injury		one year	No
Secondary	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		One year	Yes
Secondary	Global prognosis (Glasgow Outcome Scale)		3 months, 6 months and 1 year	No