Phase 3 Clinical Trial of AF-0901 - Open-label study in patients aged 15 years old or more with convulsive status epilepticus

In this clinical study in patients aged 15 years old or more, all 21 patients with convulsive status epilepticus (18.0 to 89.0 years old) achieved convulsive seizure cessation when treated with 0.15 mg/kg of AF-0901 (0.1 mg/kg if more caution is required) and 0.1 to 0.3 mg/kg of additional bolus dose until convulsive seizures cessation was achieved or until cumulative 0.6 mg/kg was reached. The incidence of adverse drug reactions was 28.6% (6 of 21 patients).