title: A prehospital randomized trial in convulsive status epilepticus.
abstract: Therapeutic strategies for patients with generalized convulsive status epilepticus (GCSE) need to be improved. We present the design of an add-on, randomized, double-blind, placebo-controlled, phase III clinical trial, to compare the efficacy for GCSE of intravenous levetiracetam in association with clonazepam versus clonazepam alone. In the therapeutic arm, 1 mg clonazepam is injected together with 2500 mg levetiracetam over 5 min. In the control arm, 1 mg clonazepam is injected together with a placebo over 5 min. This ongoing study is managed by prehospital physicians within emergency mobile units (SAMU). Adult patients with GCSE lasting more than 5 minutes are included in the study. The primary outcome measure is the percentage of patients with cessation of convulsions within 15 minutes of the onset of initial injections. Emergency medical consent is obtained from family members. An informed consent for continued participation is also obtained from patients when they wake. The study is currently recruiting participants.
authors.affiliation: AP-HP, Epilepsy Unit, Pitié-Salpêtrière Hospital, 47 boulevard de l’Hôpital, Paris Cedex 13, France. vincent.navarro@psl.aphp.fr
authors.forename: Vincent
authors.initials: V
authors.lastname: Navarro
authors.forename: Christelle
authors.initials: C
authors.lastname: Dagron
authors.forename: Sophie
authors.initials: S
authors.lastname: Demeret
authors.forename: Kim
authors.initials: K
authors.lastname: An
authors.forename: Lionel
authors.initials: L
authors.lastname: Lamhaut
authors.forename: Francis
authors.initials: F
authors.lastname: Bolgert
authors.forename: Michel
authors.initials: M
authors.lastname: Baulac
authors.forename: Pierre
authors.initials: P
authors.lastname: Carli
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D002998:Clonazepam / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D004632:Emergency Medical Services / Q000379:methods / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007275:Injections, Intravenous / Q000379:methods; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013226:Status Epilepticus / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D002998:Clonazepam; D010889:Piracetam