Status epilepticus
Conditions
Interventions
investigational material(s)
Generic name etc : AF-0901
INN of investigational material : midazolam
Therapeutic category code : 113 Antiepileptics
Dosage and Administration for Investigational material
Sponsors
Alfresa Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a seizure episode lasting for 15 minutes or longer, or with multiple seizures lasting for 5 minutes or longer, who are confirmed to have a history of status epilepticus from medical records. Patients whose seizures did not cease with intravenous diazepam, or those with a recent history of unsuccessful cessation of seizure with intravenous diazepam.
Exclusion criteria
Exclusion criteria: Patients with non-convulsive status epilepticus, acute narrow angle glaucoma or myasthenia gravis, those receiving combination therapy with an HIV protease inhibitor or HIV reverse transcriptase inhibitor, and those with a hypersensitivity to midazolam or benzodiazepine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Achievement of seizure cessation by intravenous bolus injection | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, pharmacokinetics | — |
Outcome results
None listed