To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of… (NCT05814523) | Clinical Trial Compass
WithdrawnPhase 3
To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)
Stopped: Business reasons
Austria0Started 2024-03
Plain-language summary
This is a multicenter, double-blind, randomized, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of intravenous (IV) ganaxolone versus placebo co-administered with IV antiepileptic drug (AED) according to standard of care for the treatment of RSE. Approximately 70 participants will be randomized in a 1:1 ratio to receive ganaxolone IV solution or placebo IV solution along with standard of care (SOC) IV AED.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant, participant's parent, guardian, or LAR must provide signed 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 participant.
✓. Male or females 18 years of age and older at the time of the first dose of IP.
✓. SE warranting imminent progression of treatment meeting the following criteria:
✓. Participants must have received a benzodiazepine and at least 1 of the following IV AEDs for treatment of the current episode of SE administered at an adequate dose and for a sufficient duration, in the judgement of the investigator, to demonstrate efficacy. The benzodiazepine and at least 1 of the IV AEDs must have been administered at a dose that would be expected to be effective for the termination of the current episode of SE.
✓. 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 (eg, hypoglycemia \< 50 milligrams per deciliter \[mg/dL\] or hyperglycemia \> 400 mg/dL).
✕
What they're measuring
1
Percentage of participants who will report cessation of SE within 30 minutes of investigational product (IP) initiation of at least 30 minutes duration
Timeframe: Up to 30 minutes
2
Percentage of participants who will report no escalation of treatment for persistent or recurrent SE within 36 hours of IP initiation
. Participants who have received high-dose IV anesthetics (eg, 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 admission to the ICU or 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.