A Phase 3 interventional study of Levetiracetam/Clonazepam and Clonazepam/Placebo levetiracetam IV in Status; Epilepticus, Tonic-clonic, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
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
126 studies on the registry are indexed under Status Epilepticus; 38 are open to participants now.
This study's enrollment of 203 is above the median of 70 across 74 interventional studies indexed under Status Epilepticus.
Browse Status Epilepticus studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,504 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria :
Clonazepam IV 1 mg+ levetiracetam IV 2500 mg
Drug: Levetiracetam/Clonazepam
Clonazepam IV 1 mg + placebo levetiracetam IV
Drug: Clonazepam/Placebo levetiracetam IV
Association of two anti-epileptic drugs in first line
Also known as: Association of two anti-epileptic drugs in first line
Association of placebo to an active comparator (clonazepam)
Also known as: Association of placebo to an active comparator (clonazepam)
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)
Time frame: 15 minutes
Period between the first injection and the clinical stop of the convulsion
Time frame: up to 15 minutes
Period between the first injection and the presence of signs of awakening
Time frame: up to three days
Time of hospitalization
Time frame: up to 15 days
Patient's percentage having received the second injection of clonazepam to T5 min
Time frame: 5 minutes
Patient's percentage having received an injection of second anticonvulsivant to T15 min
Time frame: 15 minutes
Patient's percentage presenting signs of awakening to T35 min
Time frame: 35 minutes
Patient's percentage having been intubated for the general anesthesia
Time frame: 35 minutes
Score of glasgow coma scale for the patients with no signs of awakening to T35 and to the arrival of the hospital
Time frame: up to 35 minutes
Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up
Time frame: up to 15 days
Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital
Time frame: up to 15 days
Frequency of adverse events and their severity
Time frame: up to 15 days
Frequency of respiratory, hemodynamic and cardiac occurence of complications
Time frame: 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
Time frame: up to 15 days
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris