Ensayos clínicos

Inclusion Criteria:

1. Participant, participant's parent, guardian, or LAR must provide signature of informed
consent/assent, and once capable (per institution guidelines), there must be
documentation of consent/assent by the participant demonstrating they are willing and
aware of the investigational nature of the study and related procedures

2. Male or females 12 years of age and older at the time of the first dose of IP

3. Convulsive or nonconvulsive SE with seizure burden warranting imminent progression to
IV anesthesia for seizure control. Ictal patterns and burden defined below.

- Convulsive SE: Clinical and EEG seizure activity or

- Nonconvulsive SE: Must have an ictal EEG pattern consistent with modified
Salzburg criteria (details provided in Appendix 2)

- Ictal burden of approximately 6 minutes or more within 30 minutes immediately
prior to IP initiation is targeted

4. Participants must have received a benzodiazepine and two or more of the following
second-line IV AEDs for treatment of the current episode of SE, administered at an
adequate dose and duration to demonstrate efficacy, in the opinion of the investigator
(guidelines for adequate doses are provided in Appendix 1)

- Fosphenytoin/phenytoin,

- Valproic acid,

- Levetiracetam,

- Lacosamide

- Brivaracetam, or

- Phenobarbital

5. BMI < 40 or, if BMI is not able to be calculated at screening, participant is assessed
by investigator as not morbidly obese

Exclusion Criteria:

1. Life expectancy of less than 24 hours

2. Anoxic brain injury or a rapidly reversable metabolic condition as the primary cause
of SE (e.g., hypoglycemia < 50 mg/dL or hyperglycemia > 400 mg/dL)

3. Participants on IV anesthesia (e.g., midazolam, propofol, thiopental, or
pentobarbital) with the primary intent specifically to treat seizures or achieve burst
suppression

4. Seizure burden or clinical state would NOT warrant IV anesthesia for seizure control
over the next 24 hours

5. Participants with an advanced directive that would not allow the institution to
administer their SOC for the treatment of SE (e.g., directive Do Not Intubate)

6. Participants known or suspected to be pregnant

7. Participants with known allergy or sensitivity to progesterone or allopregnanolone
medications/supplements

8. Receiving a concomitant IV product containing Captisol® (US-marketed products listed
in Appendix 3)

9. Known or suspected hepatic insufficiency or hepatic failure

10. Known or suspected stage 3B (moderate to severe; eGFR 44-30 mL/min/1.73m2), stage 4
(severe; eGFR 29-15 mL/min/1.73m2), or stage 5 (kidney failure; eGFR < 15
mL/min/1.73m2 or dialysis) kidney disease

11. Use of an investigational product for which less than 30 days or 5 half-lives have
elapsed from the final product administration. Participation in a non-interventional
clinical study does not exclude eligibility.

12. Known or suspected history or evidence of a medical condition that, in the
investigator's judgment, would expose participant to an undue risk of a significant
adverse event or interfere with assessments of safety or efficacy during the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/3/22. Questions regarding updates should be directed to the study team contact.