• Epilepsia · Oct 2011

    Randomized Controlled Trial

    A prehospital randomized trial in convulsive status epilepticus.

    • Vincent Navarro, Christelle Dagron, Sophie Demeret, Kim An, Lionel Lamhaut, Francis Bolgert, Michel Baulac, and Pierre Carli.
    • AP-HP, Epilepsy Unit, Pitié-Salpêtrière Hospital, 47 boulevard de l’Hôpital, Paris Cedex 13, France. vincent.navarro@psl.aphp.fr
    • Epilepsia. 2011 Oct 1;52 Suppl 8:48-9.

    AbstractTherapeutic 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.Wiley Periodicals, Inc. © 2011 International League Against Epilepsy.

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