| November 29, 2007 |
| July 30, 2009 |
| November 2007 |
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| Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to 1 year) in patients with severe traumatic brain injury [ Time Frame: one year ] [ Designated as safety issue: No ] |
| Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to one year) in patients with severe traumatic brain injury [ Time Frame: one year ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00566046 on ClinicalTrials.gov Archive Site |
| 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;
global prognosis (Glasgow Outcome Scale);
safety of Levetiracetam [ Time Frame: One year ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Prevention of Post-traumatic Seizures With Levetiracetam |
| 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 |
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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| Phase III |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Epilepsy, Post-Traumatic |
- Drug: Levetiracetam
- Drug: Placebo
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| Terminated |
| 600 |
| December 2011 |
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Inclusion Criteria:
- Age >= 18 years old
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
- 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:
- Isolated extradural hematoma
- Medical decision to limit patient's care (terminal stage of a cancer, hematological malignancies, HIV, etc.)
- Current participation in an other protocol or within one month before study entry
- Previous treatment with Levetiracetam
- Patient's follow-up judged to be difficult by the investigator
- Known allergy to either Levetiracetam or products derived from pyrrolidone or one of its excipients
- Epileptic patient treated or not (except patients treated with benzodiazepines who can be included in this protocol)
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| France |
| |
| NCT00566046 |
| Yves Rayer, Rennes University Hospital |
| EudraCT: 2006-006518-13, LOC/06-06, CIC0203/60 |
| Rennes University Hospital |
| UCB, Inc. |
| Principal Investigator: |
Arnaud Biraben, MD |
Rennes University Hospital |
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| Study Chair: |
Bruno Laviolle, MD |
Rennes University Hospital |
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| Rennes University Hospital |
| July 2009 |