drugset / Trial / NCT03336645
Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy, safety and pharmacokinetics of MHOS/SHP615 administered buccally in children with status epilepticus (convulsive) in a healthcare setting.
Timeline
- Start
- 2017-10-23
- Primary completion
- 2019-08-19
- Completion
- 2019-08-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 2.5 mg | Other |
| Subject | Midazolam | Small molecule | 5 mg | Other |
| Subject | Midazolam | Small molecule | 7.5 mg | Other |
| Subject | Midazolam | Small molecule | 10 mg | Other |