drugset / Trial / NCT01150331
Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus
Phase 3
Completed
203 enrolled
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Compare the efficiency of the association, first line, the intravenous levetiracetam and the intravenous clonazepam, in that of a monotherapy of clonazepam intravenous in the pre-hospital treatment of tonicoclonic generalised status epilepticus.
Timeline
- Start
- 2009-07
- Primary completion
- 2013-05
- Completion
- 2013-10
Publications
- Results Navarro V, Dagron C, Elie C, Lamhaut L, Demeret S, Urien S, An K, Bolgert F, Treluyer JM, Baulac M, Carli P; SAMUKeppra investigators. Prehospital treatment with levetiracetam plus clonazepam or placebo plus clonazepam in status epilepticus (SAMUKeppra): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2016 Jan;15(1):47-55. doi: 10.1016/S1474-4422(15)00296-3. Epub 2015 Nov 28.
- Navarro V, Dagron C, Demeret S, An K, Lamhaut L, Bolgert F, Baulac M, Carli P. A prehospital randomized trial in convulsive status epilepticus. Epilepsia. 2011 Oct;52 Suppl 8:48-9. doi: 10.1111/j.1528-1167.2011.03236.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levetiracetam | Other / unclassified | 2500 mg | Intravenous |
| Background | Clonazepam | Small molecule | 1 mg | Intravenous |