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 LevetiracetamGlobal 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
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