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RECRUITING
NCT05313308

A Survey of Midazolam in People With Status Epilepticus

Sponsor: Clinigen K.K.

View on ClinicalTrials.gov

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.

Official title: BUCCOLAM OROMUCOSAL SOLUTION - Special Drug Use Surveillance

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2021-06-01

Completion Date

2027-05-31

Last Updated

2025-10-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

Midazolam

Midazolam oromucosal solution

Locations (1)

Clinigen selected site

Tokyo, Japan