Actively Recruiting
BUCCOLAM Oromucosal Solution Special Drug Use Surveillance in People With Status Epilepticus
Led by Clinigen K.K. · Updated on 2026-05-18
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe the use of midazolam oromucosal solution in people with status epilepticus, a type of seizure condition. The study is conducted in Japan and focuses on monitoring side effects and symptom improvements related to midazolam. The sponsor will not influence treatment decisions but will guide clinics on recording participant outcomes. Participants will receive a single dose of midazolam oromucosal solution through the buccal mucosa (inside the cheek) when seizures begin. The dose varies by age: 2.5 mg for those between 52 weeks and under 1 year, 5 mg for 1 to under 5 years, 7.5 mg for 5 to under 10 years, and 10 mg for 10 to under 18 years. This medication is given as part of routine care during seizures. During the study, doctors will monitor participants for side effects for up to six months after treatment. The main outcomes measured include the number of participants experiencing any adverse events or serious adverse events within 24 hours of drug administration and the number who achieve therapeutic success within 30 minutes. Participants' health and responses to the drug will be recorded as part of standard medical care.
CONDITIONS
Brief Title
A Survey of Midazolam in People With Status Epilepticus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with non-convulsive status epilepticus
- Participants treated with study drug outside the medical institution
- Participants receiving an additional dose of study drug
You will not qualify if you...
- Participants who have any contraindication to midazolam
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single administration at seizure onset
Participants receive a single age-specific dose of midazolam oromucosal solution through the buccal mucosa upon onset of seizures as part of routine medical care.
1 treatment event (as part of routine medical care)
Duration - Up to 24 hours after drug administration
Participants are observed for up to 24 hours after drug administration to monitor for adverse events and therapeutic success.
1 follow-up observation period
Trial Site Locations
Total: 1 location
1
Clinigen selected site
Tokyo, Japan
Actively Recruiting
Research Team
C
Clinigen Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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