Prevention of Post-traumatic Seizures With Levetiracetam

NCT ID: NCT00566046

Last Updated: 2012-06-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-05-31

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.

Conditions

Epilepsy, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Levetiracetam

Group Type: EXPERIMENTAL

Levetiracetam

Intervention Type: DRUG

1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months

Interventions

Levetiracetam

1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months

Intervention Type: DRUG

Placebo

1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months

Intervention Type: DRUG

Other Intervention Names

Keppra

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnaud Biraben, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Bruno Laviolle, MD

Role: STUDY_CHAIR

Rennes University Hospital

Locations

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

Neurologie - CHU Rennes

Rennes, , France

Explorations Fonctionnelles Neurologiques - CHU Nantes

Rennes, , France

Neurologie - CHU Rouen

Rouen, , France

Neurologie - CHU Tours Hopital Trousseau

Tours, , France

Countries

France

Other Identifiers

CIC0203/60

Identifier Type: OTHER

Identifier Source: secondary_id

LOC/06-06

Identifier Type: OTHER

Identifier Source: secondary_id

EudraCT: 2006-006518-13

Identifier Type: -

Identifier Source: org_study_id