A Survey of Midazolam in People With Status Epilepticus

Recruiting

• Conditions: Epilepsy
• Interventions: Drug: Midazolam

• Registration Number: NCT05313308
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Midazolam	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)	Up to 24 hours after drug administration	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.
Number of Participants With Serious Adverse Events	Up to 24 hours after drug administration	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.
Number of Participants With Therapeutic Success	Up to 30 minutes after drug administration	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.

Trial Locations

Locations (1)

Takeda selected site; 🇯🇵 Tokyo, Japan