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| ID | Type | Description | Link |
|---|---|---|---|
| CIC0203/60 | Other Identifier | Rennes University Hospital | |
| LOC/06-06 | Other Identifier | Rennes University Hospital |
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Sponsor decision because of to small enrollment
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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | 1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Global prognosis (Glasgow Outcome Scale) |
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Inclusion Criteria:
Age >= 18 years old
Patient with severe brain injury defined as follow:
Initial brain CT scan performed within 48 hours after hospital admission
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)
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:
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud Biraben, MD | Rennes University Hospital | Principal Investigator |
| Bruno Laviolle, MD | Rennes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurologie - CHU Angers | Angers | France | ||||
| Neurology - CHU Bordeaux |
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| ID | Term |
|---|---|
| D004834 | Epilepsy, Post-Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Placebo | Drug | 1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months |
|
| 3 months, 6 months and 1 year |
| 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 |
| Neurologie - CHU Rennes | Rennes | 35000 | France |
| Explorations Fonctionnelles Neurologiques - CHU Nantes | Rennes | France |
| Neurologie - CHU Rouen | Rouen | France |
| Neurologie - CHU Tours Hopital Trousseau | Tours | France |
| D004827 |
| Epilepsy |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |