A Survey of Midazolam in People With Status Epilepticus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Midazolam

Intervention Type DRUG

Midazolam oromucosal solution

Interventions

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Midazolam

Midazolam oromucosal solution

Intervention Type DRUG

Other Intervention Names

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BUCCOLAM oromucosal solution

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No