Buccal midazolam for treatment of pediatric status epilepticus in community settings in Japan: A phase 3 open-label extension study

Abstract

This study assessed the safety and efficacy of buccal midazolam administered by caregivers for status epilepticus within the community setting. Pediatric patients who had previously tolerated and responded to buccally administered midazolam in a phase 3, hospital setting study (SHP615-301) were administered a single buccal midazolam dose by their trained caregiver in a community setting, following an episode of status epilepticus and before arriving at the hospital and/or emergency department. Three patients received treatment. All showed cessation of visible seizure activity within 5 minutes of treatment and absence of seizures 30 and 60 minutes after treatment. All treatmentemergent adverse events were mild, and no patients experienced respiratory depression. Caregivers reported satisfaction with the treatment experience. Buccally administered midazolam was well tolerated and effective for cessation of status epilepticus, and was safely and conveniently used by caregivers in the community setting in this study. (ClinicalTrials.gov identifier, NCT03336450)