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Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Status; Epilepticus, Tonic-clonic

Intervention: Levetiracetam/Clonazepam (Drug); Clonazepam/Placebo levetiracetam IV (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Pierre Carli, MD, PhD, Study Chair, Affiliation: Assistance Publique - Hôpitaux de Paris

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

Period between the first injection and the clinical stop of the convulsion

Period between the first injection and the presence of signs of awakening

Time of hospitalization

Patient's percentage having received the second injection of clonazepam to T5 min

Patient's percentage having received an injection of second anticonvulsivant to T15 min

Patient's percentage presenting signs of awakening to T35 min

Patient's percentage having been intubated for the general anesthesia

Score of glasgow coma scale for the patients with no signs of awakening to T35 and to the arrival of the hospital

Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up

Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital

Frequency of adverse events and their severity

Frequency of respiratory, hemodynamic and cardiac occurence of complications

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Necker Hospital, Paris 75015, France
Additional Information

Starting date: July 2009
Last updated: June 20, 2014

Page last updated: August 23, 2015

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