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Taking people in JapanNo phase

Tracks side effects of midazolam mouth solution in people with status epilepticus

Records side effects and symptom changes in people with status epilepticus taking midazolam.

Plain-language title generated from the registry record
Registry title: A Survey of Midazolam in People With Status Epilepticus

Key facts

Where
Tokyo, JapanSee the site

Where in Japan

  • TokyoTokyo, JapanTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Clinigen K.K.
Trial code
NCT05313308
Record updated
18 May 2026
Original description
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.Read full original descriptionShow less

BUCCOLAM OROMUCOSAL SOLUTION - Special Drug Use Surveillance

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.

Inclusion: Participants with non-convulsive status epilepticus; Participants treated with study drug outside the medical institution; Participants receiving an additional dose of study drug.

ClinicalTrials.gov NCT05313308