. 2017 Sep 11;82(3):342–352. doi: 10.1002/ana.25008

Table 1.

Patient Eligibility

Inclusion Criteria	Exclusion Criteria
• ≥2 years of age • EEG‐confirmed SRSE diagnosis under concomitant IV TLA treatment for ≥24 hours • Failure to control seizures after ≥6 hours on TLAs • Failure to be weaned from TLAs after ≥24 hours	• Pregnant or lactating • Known allergies to progesterone or allopregnanolone • SRSE attributed to anoxic/hypoxic encephalopathy • Children (patients <18 years) with an encephalopathy attributed to an underlying progressive neurological disorder • Clinically significant ECG abnormalities • Significant medical or surgical condition that could compromise vital organ systems, or other conditions that could place the patient at increased risk • Patients who receive IV treatment for seizure or burst suppression, which would require more than 24 hours to wean • Patients who have been exposed to other investigational medications or devices within 30 days • Patients previously enrolled in the trial

Inclusion Criteria

Exclusion Criteria

• ≥2 years of age
• EEG‐confirmed SRSE diagnosis under concomitant IV TLA treatment for ≥24 hours
• Failure to control seizures after ≥6 hours on TLAs
• Failure to be weaned from TLAs after ≥24 hours

• Pregnant or lactating
• Known allergies to progesterone or allopregnanolone
• SRSE attributed to anoxic/hypoxic encephalopathy
• Children (patients <18 years) with an encephalopathy attributed to an underlying progressive neurological disorder
• Clinically significant ECG abnormalities
• Significant medical or surgical condition that could compromise vital organ systems, or other conditions that could place the patient at increased risk
• Patients who receive IV treatment for seizure or burst suppression, which would require more than 24 hours to wean
• Patients who have been exposed to other investigational medications or devices within 30 days
• Patients previously enrolled in the trial

EEG = electroencephalogram; ECG = electrocardiogram; SRSE = super‐refractory status epilepticus; IV = intravenous; TLAs = anesthetic third‐line agent.