Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Anticonvulsants; Clonazepam; Etiracetam; Levetiracetam; Piracetam

Criteria

Inclusion criteria :

• Age ≥ 18 years

• Patient taken care by a prehospital medical team participating in the study

• Diagnosis of tonicoclonic generalized status epilepticus confirmed on the spot by a physician of the team.

Exclusion criteria :

• Parent or the reliable person indicated by the patient present not giving its agreement for the inclusion

• Pregnancy clinically detectable or known for close relations at the time of the status epilepticus

• tonicoclonic generalized status epilepticus after anoxia post cardiac arrest

• Patient having already received another treatment for the same episode of status epilepticus

• Patient having already participated in the study during a previous episode of status epilepticus

• Patient in "latent" status epilepticus. Definition : patient in the coma having epileptic demonstrations (CLONISMS MYOCLONISMS) small or invalid, contrasting with permanent generalized electric seizures on the EEG

• Patient presenting certain diagnosis of pseudo name psychogenic seizure

• Patient whose neurological status requires an immediate surgery (traumatism)

• Patient having a hyper-responsiveness about the levetiracetam or about the other by-products of pyrrolidone or an one of the excipients

• Patient having a hyper-responsiveness about the clonazepam, about the benzodiazepins or about one of the other constituents of the product

• Patient under medical guardianship

• Not membership in a schema of medical assurance.