A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)
Has a diagnosis of focal onset epilepsy according to the International League Against Epilepsy Classification of Epilepsy (2017).
Prior to randomization, past evidence by CT or MRI that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.
Participant must attest to be taking stable doses of 1 or up to 3 acceptable ASMs for at least 4 weeks prior to screening and during screening prior to Day 1.
Has at least 4 countable focal onset seizures during the 4 weeks of Observation Period immediately prior to randomization with no more than 21 days seizure free during this period.
evidence of experiencing pseudo or psychogenic seizures
cluster seizures where the individual seizures cannot be counted
an episode of convulsive status epilepticus requiring hospitalization and intubation
seizures secondary to illicit drug or alcohol use
Parallel
40 mg/day vormatrogine for 12 weeks
DrugOnce daily oral
30 mg/day vormatrogine for 12 weeks
DrugOnce daily oral
20 mg/day vormatrogine for 12 weeks
DrugOnce daily oral
Placebo
DrugOnce daily oral
To evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
Median percent change in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for vormatrogine compared to placebo.
To further evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
Proportion of participants experiencing a ≥50% reduction in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period (Responder Rate) for vormatrogine compared to placebo
To assess trends over time in efficacy of vormatrogine on focal seizure frequency
Percent change in monthly focal seizure frequency from the Screening/Observation Period to the Treatment Period for vormatrogine compared with placebo.
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Incidence and severity of TEAEs, including discontinuation of study drug due to TEAEs
To assess the safety and tolerability of vormatrigine in adults with focal seizures
Change in tympanic temperature in Celsius
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