Observational Study of Midazolam Oromucosal Solution for Treating Status Epilepticus in Japan

What this Trial Is About

This research aims to observe the use of midazolam oromucosal solution in people with status epilepticus, a type of seizure condition. The study is conducted in Japan and focuses on monitoring side effects and symptom improvements related to midazolam. The sponsor will not influence treatment decisions but will guide clinics on recording participant outcomes. Participants will receive a single dose of midazolam oromucosal solution through the buccal mucosa inside the cheek when seizures begin. The dose varies by age 2.5 mg for those between 52 weeks and under 1 year, 5 mg for 1 to under 5 years, 7.5 mg for 5 to under 10 years, and 10 mg for 10 to under 18 years. This medication is given as part of routine care during seizures. During the study, doctors will monitor participants for side effects for up to six months after treatment. The main outcomes measured include the number of participants experiencing any adverse events or serious adverse events within 24 hours of drug administration and the number who achieve therapeutic success within 30 minutes. Participants health and responses to the drug will be recorded as part of standard medical care.

A Survey of Midazolam in People With Status Epilepticus