CompletedPhase 3

Randomized Therapy In Status Epilepticus

United States100 participantsStarted 2020-12-09

Plain-language summary

This study evaluated the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Participant, participant's parent, guardian, or legal authorized representative (LAR) must provide signed 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. Where allowed by law, where the participant lacks the capacity to make informed decisions regarding his/her medical treatment options, the treating clinician may follow their deferred consenting practices. The clinician will make the final decision based on the best interests of the particiapant.
✓. Male or females 12 years of age and older at the time of the first dose of IP
✓. SE meeting the following criteria:
✓. Participants must have received any two or more of the following agents for treatment of the current episode of SE administered at an adequate dose and for a sufficient duration, in the judgment of the investigator, to demonstrate efficacy
✓. Body mass index (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 an uncorrected rapidly reversable metabolic condition as the primary cause of SE (e.g., hypoglycemia \< 50 milligram per deciliter \[mg/dL\] or hyperglycemia \> 400 mg/dL)
✕. Participants who have received high-dose IV anesthetics (e.g., midazolam, propofol, thiopental, or pentobarbital) during the current episode of SE for more than 18 hours, or who continue to have clinical or electrographic evidence of persistent seizures while receiving high-dose IV anesthetics.
✕. Clinical condition or advance directive that would NOT permit use of IV anesthesia
✕. 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 leading to impaired synthetic liver function.

What they're measuring

Percentage of Participants With SE Cessation Within 30 Minutes of Investigational Product (IP) Initiation Without Medications for the Acute Treatment of SE

Timeframe: Up to 30 minutes

Percentage of Participants With no Progression to Intravenous (IV) Anesthesia for 36 Hours Following Investigational Product (IP) Initiation

Timeframe: Up to 36 hours after IP initiation

Number of Participants With Treatment Emergent Adverse Events

Timeframe: Up to 4 weeks after IP initiation

Trial details

NCT IDNCT04391569

SponsorMarinus Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-30

Results submitted2025-03-26

View on ClinicalTrials.gov More Status Epilepticus trials