Name: RAISE (A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous ganaxolone in status epilepticus)
Contact: Ralisa Pop (Lead CRC, 352-273-5550 x45693) and Jessica Spana (Back-up CRC, 352-273-5554), Dr. Billy Roth (PI)
Enrolling hours: Everyday but no enrollments after 5pm, still need to work out on call schedule.
- 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
- Male or females 18 years of age and older at the time of the first dose of IP
- 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
- Ictal burden of approximately 6 minutes or more within 30 minutes immediately prior to IP initiation is targeted
- 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
- Valproic acid,
- Brivaracetam, or
- BMI < 40 or, if BMI is not able to be calculated at screening, participant is assessed by investigator as not morbidly obese
- Life expectancy of less than 24 hours
- 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)
- Participants on IV anesthesia (e.g., midazolam, propofol, thiopental, or pentobarbital) with the primary intent specifically to treat seizures or achieve burst suppression
- Seizure burden or clinical state would NOT warrant IV anesthesia for seizure control over the next 24 hours
- 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)
- Participants known or suspected to be pregnant
- Participants with known allergy or sensitivity to progesterone or allopregnanolone medications/supplements
- Receiving a concomitant IV product containing Captisol®
- Known or suspected hepatic insufficiency or hepatic failure
- 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 < 15mL/min/1.73m2 or dialysis) kidney disease
- 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.
- 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.