RecruitingPhase 3NCT07010471

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


Sponsor

Praxis Precision Medicines

Enrollment

160 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 2 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 1.0mg/kg/day PRAX-562, a drug called 1.5mg/kg/day PRAX-562, and others for people with developmental and epileptic encephalopathy 1. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 2 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG1.0mg/kg/day PRAX-562

Once daily orally or gastronomy/jejunostomy

DRUG1.5mg/kg/day PRAX-562

Once daily orally or gastronomy/jejunostomy

DRUGPlacebo

Once daily orally or gastronomy/jejunostomy


Locations(11)

Praxis Research Site

La Jolla, California, United States

Praxis Research Site

Gulf Breeze, Florida, United States

Praxis Research Site

Chevy Chase, Maryland, United States

Praxis Research Site

Roseville, Minnesota, United States

Praxis Research Site

Hackensack, New Jersey, United States

Praxis Research Site

Philadelphia, Pennsylvania, United States

Praxis Research Site

Heidelberg, Victoria, Australia

Praxis Research Site

Rio Grande, Do Sul, Brazil

Praxis Research Site

Paraná, Brazil

Praxis Research Site

Rio de Janeiro, Brazil

Praxis Research Site

São Paulo, Brazil

View Full Details on ClinicalTrials.gov

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NCT07010471