NCT06999902

Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)

A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Praxis Precision Medicines · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)

Detailed description

PRAX-628-321 (POWER1) is a double-blind, randomized, multicenter, trial to evaluate the efficacy and safety of PRAX-628 in adults who can attest to concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications.

Conditions

• Focal Seizure

Interventions

Type	Name	Description
DRUG	20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks	Once daily oral
DRUG	Placebo	Once daily oral

Timeline

• Start date: 2024-12-11
• Primary completion: 2025-11-24
• Completion: 2025-12-08
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

26 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study