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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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Clinigen selected site
Tokyo, Japan
Start Date
June 1, 2021
Primary Completion Date
May 31, 2027
Completion Date
May 31, 2027
Last Updated
October 6, 2025
50
ESTIMATED participants
Midazolam
DRUG
Lead Sponsor
Clinigen K.K.
NCT06700356
NCT02531880
NCT05871372
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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