A Survey of Midazolam in People With Status Epilepticus

Last updated: September 30, 2025
Sponsor: Clinigen K.K.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

Midazolam

Clinical Study ID

NCT05313308
BUCCOLAM PMS
jRCT2031210712
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria

  • Participants with non-convulsive status epilepticus

  • Participants treated with study drug outside the medical institution

  • Participants receiving an additional dose of study drug

Exclusion Criteria Participants have any contraindication to midazolam.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Midazolam
Phase:
Study Start date:
June 01, 2021
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Takeda selected site

    Tokyo,
    Japan

    Site Not Available

  • Clinigen selected site

    Tokyo 1850147,
    Japan

    Active - Recruiting

  • Takeda selected site

    Tokyo 1850147,
    Japan

    Active - Recruiting

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