NCT07505004

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Praxis Precision Medicines · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)

Detailed 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.

Conditions

• Focal Epilepsy

Interventions

Type	Name	Description
DRUG	40 mg/day vormatrogine for 12 weeks	Once daily oral
DRUG	30 mg/day vormatrogine for 12 weeks	Once daily oral
DRUG	20 mg/day vormatrogine for 12 weeks	Once daily oral
DRUG	Placebo	Once daily oral

Timeline

• Start date: 2026-01-29
• Primary completion: 2027-01-01
• Completion: 2027-05-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study