Status:
COMPLETED
Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Status; Epilepticus, Tonic-clonic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 his...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT01150331
Start Date
July 1 2009
End Date
October 1 2013
Last Update
June 23 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Necker Hospital
Paris, France, 75015