Convulsive status epilepticus
Conditions
Interventions
investigational material(s)
Generic name etc : midazolam
INN of investigational material : midazolam
Therapeutic category code : 113 Antiepileptics
Dosage and Administration for Investigational materi
Sponsors
Alfresa Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a convulsive seizures episode lasting for 5 min or longer at the beginning of first intravenous bolus injection
Exclusion criteria
Exclusion criteria: Patients with current or previous history of psychogenic non-epileptic seizure, those with acute narrow angle glaucoma or myasthenia gravis, those receiving combination therapy with an HIV protease inhibitor, formulation contaning efavirenz or cobicistat, and those with a hypersensitivity to midazolam or benzodiazepine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Achievement of convulsive seizure cessation in the final assessment of bolus intravenous injection | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Achievement of convulsive seizure cessation in the final treatment assessment (Bolus intravenous injection period only: Final assessment of bolus intravenous injection period, and Continuous intravenous infusion period: Final assessment of continuous intravenous infusion period) efficacy Recurrence of convulsive seizures in 24-hour observation during continuous intravenous infusion efficacy Achievement of cumulative convulsive seizure cessation by cumulative dose in the final assessment of bolus intravenous injection period efficacy Recurrence of convulsive seizures in the final assessment during the post-treatment observation period (24 hours after the end of the last dose during bolus intravenous injeciton period or continuous intravenous infusion period) | — |
Countries
Japan
Outcome results
None listed