RecruitingNCT05313308

A Survey of Midazolam in People With Status Epilepticus

BUCCOLAM OROMUCOSAL SOLUTION - Special Drug Use Surveillance


Sponsor

Clinigen K.K.

Enrollment

50 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a survey in Japan of midazolam oromucosal solution used to treat people with status epilepticus. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from midazolam oromucosal solution and to check if midazolam oromucosal solution improves symptoms of status epilepticus. During the study, participants with status epilepticus will take midazolam oromucosal solution according to their clinic's standard practice. The study doctors will check for side effects from midazolam for 6 months.


Eligibility

Inclusion Criteria3

  • Participants with non-convulsive status epilepticus
  • Participants treated with study drug outside the medical institution
  • Participants receiving an additional dose of study drug

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Interventions

DRUGMidazolam

Midazolam oromucosal solution


Locations(1)

Clinigen selected site

Tokyo, Japan

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NCT05313308


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