Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus

Phase 3

Completed

• Conditions: Status; Epilepticus, Tonic-clonic
• Interventions: Drug: Levetiracetam/Clonazepam; Drug: Clonazepam/Placebo levetiracetam IV

• Registration Number: NCT01150331
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-06-23
• Study First Posted: 2010-06-24
• Primary Completion: 2013-05
• Study Completion: 2013-10
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-20
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clonazepam + levetiracetam	Levetiracetam/Clonazepam	Clonazepam IV 1 mg+ levetiracetam IV 2500 mg
Clonazepam + placebo	Clonazepam/Placebo levetiracetam IV	Clonazepam IV 1 mg + placebo levetiracetam IV

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Frequency of adverse events and their severity	up to 15 days
Time of hospitalization	up to 15 days
Patient's percentage presenting signs of awakening to T35 min	35 minutes
Patient's percentage having been intubated for the general anesthesia	35 minutes
Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up	up to 15 days
Period between the first injection and the clinical stop of the convulsion	up to 15 minutes
Patient's percentage having received an injection of second anticonvulsivant to T15 min	15 minutes
Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital	up to 15 days
Period between the first injection and the presence of signs of awakening	up to three days
Patient's percentage having received the second injection of clonazepam to T5 min	5 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
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

Trial Locations

Locations (1)

Necker Hospital; 🇫🇷 Paris, France