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 convulsionPeriod 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
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