A Survey of Midazolam in People With Status Epilepticus

Epilepsy Clinical Trial

Official title:

BUCCOLAM OROMUCOSAL SOLUTION - Special Drug Use Surveillance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313308
• Other study ID #: TAK-815-5001
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Midazolam
Midazolam oromucosal solution

Locations

Country	Name	City	State
Japan	Takeda selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)	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.	Up to 24 hours after drug administration
Primary	Number of Participants With Serious Adverse Events	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.	Up to 24 hours after drug administration
Primary	Number of Participants With Therapeutic Success	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.	Up to 30 minutes after drug administration