A Survey of Midazolam in People With Status Epilepticus

NCT05313308 | Recruiting

• 2 other identifiers: BUCCOLAM PMSjRCT2031210712
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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.

Drug: Midazolam

Interventions

Midazolam DRUG

Midazolam oromucosal solution

Also known as: BUCCOLAM oromucosal solution

Midazolam

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with status epilepticus who received midazolam oromucosal solution

You may qualify if:

• Participants with non-convulsive status epilepticus
• Participants treated with study drug outside the medical institution
• Participants receiving an additional dose of study drug

Sponsors & Collaborators

• Clinigen K.K.: lead

Study Sites (1)

Clinigen selected site

Tokyo, Japan

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Epilepsy

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Clinigen K.K.

  STUDY DIRECTOR

Central Study Contacts

Clinigen Contact

CONTACT

+81-3-6869-0663; Koichi.Matsumura@clinigen.co.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: June 1, 2021
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)