NCT07010471

A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine

A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Relutrigine in Participants With DEE Followed by an Open-Label Extension

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Praxis Precision Medicines · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Relutrigine in Participants with Developmental and Epileptic Encephalopathies Followed by an Open-Label Extension

Conditions

• Developmental and Epileptic Encephalopathy 1

Interventions

Type	Name	Description
DRUG	1.0mg/kg/day PRAX-562	Once daily orally or gastronomy/jejunostomy
DRUG	1.5mg/kg/day PRAX-562	Once daily orally or gastronomy/jejunostomy
DRUG	Placebo	Once daily orally or gastronomy/jejunostomy

Timeline

• Start date: 2025-07-09
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2025-06-08
• Last updated: 2025-12-18

Locations

5 sites across 2 countries: United States, Brazil

Regulatory

• FDA-regulated drug study