NCT05313308Recruiting
A Survey of Midazolam in People With Status Epilepticus
BUCCOLAM OROMUCOSAL SOLUTION - Special Drug Use Surveillance
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 29 Mar 2022
- Start date
- 1 Jun 2021
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Clinigen K.K.
- Diseases
- Epilepsy
- NCT number
- NCT05313308
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Jun 2021 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Participants with non-convulsive status epilepticus
- Participants treated with study drug outside the medical institution
- Participants receiving an additional dose of study drug
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinigen selected site Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.