BUCCOLAM OROMUCOSAL SOLUTION - Special Drug Use Surveillance

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Participants with non-convulsive status epilepticus

• Participants treated with study drug outside the medical institution

• Participants receiving an additional dose of study drug

Locations
Other Locations
Japan
Clinigen selected site
RECRUITING
Tokyo
Contact Information
Primary
Clinigen Contact
Koichi.Matsumura@clinigen.co.jp
+81-3-6869-0663
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Clinigen K.K.

This content was sourced from clinicaltrials.gov

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