Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus

Study Overview
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Brief Summary
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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
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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

Official Title
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Efficiency of Levetiracetam Intravenous in Association With Clonazepam Versus Clonazepam Alone in Prehospital Care of Generalised Tonicoclonic Status Epilepticus

Conditions
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Status; Epilepticus, Tonic-clonic

Intervention / Treatment
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* Drug: Levetiracetam/Clonazepam
* Drug: Clonazepam/Placebo levetiracetam IV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clonazepam + levetiracetam<br>Clonazepam IV 1 mg+ levetiracetam IV 2500 mg | Drug: Levetiracetam/Clonazepam<br>* Association of two anti-epileptic drugs in first line<br>* Other names: Association of two anti-epileptic drugs in first line;|
| Active Comparator: Clonazepam + placebo<br>Clonazepam IV 1 mg + placebo levetiracetam IV | Drug: Clonazepam/Placebo levetiracetam IV<br>* Association of placebo to an active comparator (clonazepam)<br>* Other names: Association of placebo to an active comparator (clonazepam);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period between the first injection and the clinical stop of the convulsion |  | up to 15 minutes | 
| Period between the first injection and the presence of signs of awakening |  | up to three days | 
| Time of hospitalization |  | up to 15 days | 
| Patient's percentage having received the second injection of clonazepam to T5 min |  | 5 minutes | 
| Patient's percentage having received an injection of second anticonvulsivant to T15 min |  | 15 minutes | 
| Patient's percentage presenting signs of awakening to T35 min |  | 35 minutes | 
| Patient's percentage having been intubated for the general anesthesia |  | 35 minutes | 
| Score of glasgow coma scale for the patients with no signs of awakening to T35 and to the arrival of the hospital |  | up to 35 minutes | 
| Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up |  | up to 15 days | 
| Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital |  | up to 15 days | 
| Frequency of adverse events and their severity |  | up to 15 days | 
| Frequency of respiratory, hemodynamic and cardiac occurence of complications |  | up to 15 days | 
| 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 |  | up to 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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status epilepticus, generalised convulsive status epilepticus, first line treatments, double-blind randomized controlled trial, prehospital treatment