A Survey of Midazolam in People With Status Epilepticus

Takeda

Status: Enrolling

Conditions: Epilepsy

Treatments: Drug: Midazolam

Study type: Observational

Funder types: Industry

Identifiers

NCT05313308

TAK-815-5001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

50 participants in 1 patient group

Midazolam

Description:

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.

Treatment:

Drug: Midazolam