Survey of midazolam treatment for status epilepticus
BUCCOLAM OROMUCOSAL SOLUTION - Special Drug Use Surveillance
Clinigen K.K. · NCT05313308
This study looks at how well midazolam works and its side effects in treating people with status epilepticus in Japan over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Clinigen K.K. (industry) |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT05313308 on ClinicalTrials.gov |
What this trial studies
This observational study surveys the use of midazolam oromucosal solution in treating individuals with status epilepticus in Japan. Participants will receive midazolam according to their clinic's standard practice, while the study will monitor for side effects and assess symptom improvement over a period of six months. The study aims to gather data on the safety and efficacy of midazolam in this specific patient population without direct involvement from the sponsor in treatment decisions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with non-convulsive status epilepticus who are receiving midazolam treatment.
Not a fit: Patients with contraindications to midazolam will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of midazolam for treating status epilepticus.
How similar studies have performed: While this approach is observational, similar studies have shown promise in evaluating treatment efficacy and safety in epilepsy management.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Tokyo
- Clinigen selected site — Tokyo, Japan (RECRUITING)
Study contacts
- Study coordinator: Clinigen Contact
- Email: Koichi.Matsumura@clinigen.co.jp
- Phone: +81-3-6869-0663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy