drugset / Trial / NCT03336450
Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if the investigational treatment, MHOS/SHP615, is safe and effective in children with status epilepticus (SE) (convulsive) in the community setting. This study is open-label extension for patients who completed the SHP615-301 study and who tolerated and responded to MHOS/SHP615 treatment in the hospital setting.
Timeline
- Start
- 2018-04-23
- Primary completion
- 2020-10-13
- Completion
- 2020-10-13
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 |