An observational study in Epilepsy, sponsored by Clinigen K.K.. Recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Clinigen K.K. · Observational
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 50 is below the median of 102 across 521 observational studies indexed under Epilepsy.
Browse Epilepsy studies →This is the only study on the registry with Clinigen K.K. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Participants with status epilepticus who received midazolam oromucosal solution
Inclusion Criteria
Exclusion Criteria Participants have any contraindication to midazolam.
Participants will receive a single age-specific dose midazolam oromucosal solution through buccal mucosa upon onset of seizures. Dose will be dependent by age of participants as follows: \>= 52 weeks and \< 1 year; 2.5 mg/dose of midazolam, for \>= 1 year and \< 5 years; 5 mg/dose of midazolam, for \>= 5 years and \< 10 years; 7.5 mg/dose of midazolam, for \>= 10 years and \< 18 years; 10 mg/dose of midazolam. Participants received interventions as part of routine medical care.
Drug: Midazolam
Midazolam oromucosal solution
Also known as: BUCCOLAM oromucosal solution
Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product (including an investigational product for a new indication in Japan), whether or not related to the pharmaceutical product.
Time frame: Up to 24 hours after drug administration
Number of Participants With Serious Adverse Events
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: Up to 24 hours after drug administration
Number of Participants With Therapeutic Success
Therapeutic success is defined as cessation of seizure activity within 10 minutes and sustained absence of seizure activity for 30 minutes following the first dose of midazolam oromucosal solution. Number of participants with therapeutic success will be reported.
Time frame: Up to 30 minutes after drug administration
Plan to share: No
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