New study monitors seizure Drug's safety in japan

NCT ID NCT05313308

Recruiting now Symptom relief Sponsor: Clinigen K.K. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tracks 50 people in Japan who receive BUCCOLAM (midazolam) for status epilepticus, a type of prolonged seizure. Doctors will record side effects and whether the drug stops seizures within 10 minutes. The goal is to ensure the medicine is safe and works well in everyday medical practice.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: midazolam oromucosal solution (BUCCOLAM)
What this could lead to: If successful, this study will confirm that BUCCOLAM is safe and effective for stopping prolonged seizures in a real-world setting in Japan.
What could go wrong: This is a small, observational study with no control group, so results may not prove cause and effect. Side effects like breathing problems are possible with midazolam.

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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

EPILEPSY

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Clinigen selected site
RECRUITING

Tokyo, Japan

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