A Survey of Midazolam in People With Status Epilepticus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Midazolam.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
BUCCOLAM OROMUCOSAL SOLUTION - Special Drug Use Surveillance
Overview
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.
Interventions
- Drug Midazolam
Midazolam oromucosal solution
Primary outcome measures
- Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE) [Time frame: Up to 24 hours after drug administration]
- Number of Participants With Serious Adverse Events [Time frame: Up to 24 hours after drug administration]
- Number of Participants With Therapeutic Success [Time frame: Up to 30 minutes after drug administration]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Clinigen selected site — Tokyo
Identifiers
NCT: NCT05313308 · BUCCOLAM PMS · jRCT2031210712