Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPraxis Precision Medicines

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

Treatment groups

300 Participants
are divided into 4 treatment groups

Sponsors and collaborators