About this trial
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- 40 mg/day vormatrogine for 12 weeks
- 30 mg/day vormatrogine for 12 weeks
- 20 mg/day vormatrogine for 12 weeks
- Placebo