Randomized Therapy In Status Epilepticus (RAISE)
Status Epilepticus
About this trial
This is an interventional treatment trial for Status Epilepticus focused on measuring Seizure, Status Epilepticus, Convulsive Status Epilepticus, Non-Convulsive Status Epilepticus, Epilepsy
Eligibility Criteria
Inclusion Criteria:
- 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 12 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 (details provided in Appendix 2)
- 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 (guidelines for adequate doses are provided in Appendix 1)
- Fosphenytoin/phenytoin,
- Valproic acid,
- Levetiracetam,
- Lacosamide
- Brivaracetam, or
- Phenobarbital
- BMI < 40 or, if BMI is not able to be calculated at screening, participant is assessed by investigator as not morbidly obese
Exclusion Criteria:
- 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® (US-marketed products listed in Appendix 3)
- 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 < 15 mL/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.
Sites / Locations
- Marinus Research SiteRecruiting
- Marinus Research Site
- Marinus
- Marinus Research SiteRecruiting
- Marinus Research Site
- Marinus Research Site
- Marinus Research SiteRecruiting
- Marinus Research Site #1Recruiting
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research SiteRecruiting
- Marinus Research Site
- Marinus Research SiteRecruiting
- Marinus Research Site
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research Site #1Recruiting
- Marinus Research Site
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research Site
- Marinus Research Site
- Marinus Research SiteRecruiting
- Marinus Research SiteRecruiting
- Marinus Research Site #1
- Marinus Research Site #2
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research SiteRecruiting
- Marinus Research Site
- Marinus Research SiteRecruiting
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
- Marinus Research Site
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
IV Placebo
IV ganaxolone active
Placebo bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper
Ganaxolone bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper