Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03336450 | Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting | PHASE3 | COMPLETED | 3 | — | — | Apr 23, 2018 | Oct 13, 2020 | Sep 14, 2021 | 23 | Japan |
| NCT03336645 | Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan | PHASE3 | COMPLETED | 25 | — | — | Oct 23, 2017 | Aug 19, 2019 | Jul 31, 2020 | 23 | Japan |
Therapeutic success was defined as cessation of visible seizure activity within 10 minutes and sustained absence of visible seizure activity for 30 minutes following a single dose of SHP615 without the need for additional rescue medication. Number of participants with therapeutic success were reported.
Respiratory depression, included the following measures within 24 hours after administration of the IP: i) Persistent decrease in oxygen saturation to \<92 percent (%) measured up to 24 hours post-dose (i.e., \<92% on room air for 2 minutes or more after dosing while monitoring \[per healthcare setting protocol and/or the clinical judgment of the physician\]. ii) Increase in respiratory effort such that assisted ventilation is used (bag-valve-mask ventilation or endotracheal intubation). Number of participants with respiratory depression were reported.
Response rate was defined as the percentage of participants with therapeutic success. Therapeutic success was defined as the cessation of visible seizure activity within 10 minutes with a sustained absence of visible seizure activity for 30 minutes following a single dose of MHOS/SHP615 without the need for additional rescue medication.
| Arm | Type | Description |
|---|---|---|
| SHP615 | EXPERIMENTAL | Participants will receive a single age-specific dose (approximately 0.25 to 0.5 milligram per kilogram \[mg/kg\] as midazolam) of SHP615 oromucosal solution through buccal route upon onset of seizures. |
| Name | Type | Description |
|---|---|---|
| SHP615 | DRUG | SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg). |
| MHOS/SHP615 | DRUG | MHOS/SHP615 |
Inclusion Criteria: * Subjects who completed the SHP615-301 study and who tolerated and responded to treatment with MHOS/SHP615 in the hospital and/or emergency room, and are considered stable for discharge from the hospital. * Subjects who are greater than (\>) 6 months and less than (\<) 18 years...