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

Phase 3 Recruiting 160 enrolled Praxis Precision Medicines

RandomizedSequentialQuadruple-blindTreatment

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

Timeline

Start: 2025-07-09
Primary completion: 2026-12
Completion: 2027-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PRAX-562	Unknown	1 mg/kg	Oral
Subject	PRAX-562	Unknown	1.5 mg/kg	Oral

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

Summary

Timeline

Drugs

Indications