A Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures
Praxis Precision Medicines
Summary
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)
Description
PRAX-628-322 (POWER 2) is a Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 immedia…
Interventions
- Drug40 mg/day vormatrogine for 12 weeks
Once daily oral
- Drug30 mg/day vormatrogine for 12 weeks
Once daily oral
- Drug20 mg/day vormatrogine for 12 weeks
Once daily oral
- DrugPlacebo
Once daily oral
Locations (7)
- Praxis Research SiteMiami, Florida
- Praxis Research SiteMiami Lakes, Florida
- Praxis Research SiteNaples, Florida
- Praxis Research SiteMarlboro, New Jersey
- Praxis Research SiteNiagara Falls, New York
- Praxis Research SiteRaleigh, North Carolina