Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus (SAMU-KEPPRA)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Status; Epilepticus, Tonic-clonic

Treatments

Drug: Clonazepam/Placebo levetiracetam IV

Drug: Levetiracetam/Clonazepam

Study type

Interventional

Funder types

Other

Identifiers

NCT01150331

P070704

Details and patient eligibility

About

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.

Full description

At this time, the prehospital treatment of the status epilepticus use some molecule ("FOSPHENYLOINE") with large contra-indications. In this case the physician is not able to know the past medical history of the patient, the biological examinations and so he can not decide which molecules he can use.

The levetiracetam is a knowledge medication in the epilepsy since more than twenty years. One of specificity of the levetiracetam is to be able to be used in all situations (no clinical or biological contre-indication). This molecule seems like to be very interesting to be used in prehospital system.

The goal of this study is to evaluate the association levetiracetam / clonazepam in first line in the prehospital treatment of the status epilepticus

Enrollment

203 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.