Clinical trial NCT01150331: Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus
Official title: Efficiency of Levetiracetam Intravenous in Association With Clonazepam Versus Clonazepam Alone in Prehospital Care of Generalised Tonicoclonic Status Epilepticus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Status; Epilepticus, Tonic-clonic
Keywords: status epilepticus
generalised convulsive status epilepticus
first line treatments
double-blind randomized controlled trial
prehospital treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-06-24
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility 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.

Primary outcomes:
measure: Patient's percentage having stopped convulsing in the 15 minutes following the injection. The stop of the crisis is defined as the stop of all epileptic movements (myoclonic, clonic or tonic)
timeFrame: 15 minutes
Secondary outcomes:
measure: Period between the first injection and the clinical stop of the convulsion
timeFrame: up to 15 minutes
measure: Period between the first injection and the presence of signs of awakening
timeFrame: up to three days
measure: Time of hospitalization
timeFrame: up to 15 days
measure: Patient's percentage having received the second injection of clonazepam to T5 min
timeFrame: 5 minutes
measure: Patient's percentage having received an injection of second anticonvulsivant to T15 min
timeFrame: 15 minutes
measure: Patient's percentage presenting signs of awakening to T35 min
timeFrame: 35 minutes
measure: Patient's percentage having been intubated for the general anesthesia
timeFrame: 35 minutes
measure: Score of glasgow coma scale for the patients with no signs of awakening to T35 and to the arrival of the hospital
timeFrame: up to 35 minutes
measure: Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up
timeFrame: up to 15 days
measure: Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital
timeFrame: up to 15 days
measure: Frequency of adverse events and their severity
timeFrame: up to 15 days
measure: Frequency of respiratory, hemodynamic and cardiac occurence of complications
timeFrame: up to 15 days
measure: Analysis of the main criteria of efficiency by sous groups according to the etiology of the generalised tonic-clonic status epilepticus and according to this duration during the therapeutic clinical care
timeFrame: up to 15 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre Carli, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.