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NCT07010471PHASE3Recruiting

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

Praxis Precision Medicines

Start Date

7/9/2025

Completion Date

11/1/2027

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 Criteria

Age Range: 2 years to 65 years

Inclusion Criteria: * Has a documented diagnosis of a developmental and epileptic encephalopathy. * Onset of seizures \<12 years old. * Has a weight \>7 kg at the time of signing consent/assent. Exclusion Criteria: * Has a history of left bundle branch block, arrhythmias, Brugada syndrome, congenital heart disease, familial short QT syndrome, or family history of sudden death or ventricular arrhythmias, including idiopathic ventricular fibrillation. * Had 2 or more episodes of convulsive status epilepticus requiring hospitalization and intubation in the 6 months prior to Screening. * Has an abnormal ECG reading, including a QT interval corrected for heart rate using Bazett's method (QTcB) \<350 and \>450 ms (males), or \<360 and \>460 ms (females) at Screening and/or on Day 1. * Any nerve stimulation must have been placed at least 3 months prior to Screening with at least 1 month of stable settings prior to Screening. * Has received any other experimental or investigational drug, device, or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, including any prior use of gene therapy. * Is currently pregnant or breastfeeding or is planning to become pregnant during the clinical trial or within 5 half-lives of the last study drug dose.

Interventions

DRUG

1.0mg/kg/day PRAX-562

DRUG

1.5mg/kg/day PRAX-562

DRUG

Placebo

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Conditions

Developmental and Epileptic Encephalopathy 1

Locations

Praxis Research Site

La Jolla, California 92037

United States

Praxis Research Site

Gulf Breeze, Florida 32561

United States

Praxis Research Site

Chevy Chase, Maryland 20815

United States

Praxis Research Site

Roseville, Minnesota 55113

United States

Praxis Research Site

Hackensack, New Jersey 07601

United States

Praxis Research Site

Philadelphia, Pennsylvania 19104

United States

Praxis Research Site

Heidelberg, Victoria 3084

Australia

Praxis Research Site

Rio Grande, Do Sul 90610

Brazil

Praxis Research Site

Paraná, 80250

Brazil

Praxis Research Site

Rio de Janeiro, 20231

Brazil

Praxis Research Site

São Paulo, 15090

Brazil