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Relutrigine for Developmental and Epileptic Encephalopathy (DEE)

This study is testing a medication called relutrigine (also known as PRAX-562) for people with Developmental and Epileptic Encephalopathy (DEE), a severe form of epilepsy. The study aims to see how well relutrigine works to reduce seizures, how safe it is, and how the body handles it. Participants will receive either relutrigine at one of two doses (1.0mg/kg/day or 1.5mg/kg/day) or a placebo (an inactive substance). We will compare seizure frequency between those who receive relutrigine and those who receive placebo after 16 weeks. You may be able to join if you are between 2 and 65 years old, have a documented DEE diagnosis, and started having seizures before age 12. The study is currently recruiting 160 participants.

Study design
This is a Phase 3, randomized, multi-center, double-blind, placebo-controlled study. It will involve 160 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring seizure frequency is at 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07010471

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

Active, Not Recruiting
PHASE3Ages 2–65InterventionalTreatment
Praxis Precision Medicines
~160 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:1.0mg/kg/day PRAX-5621.5mg/kg/day PRAX-562Placebo

At a glance

Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the effect of relutrigine on seizure frequency in participants with DEEs compared to placebo
Measured over 16 weeks

Conditions

Developmental and Epileptic Encephalopathy 1

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Developmental and Epileptic Encephalopathy

NCT07010471

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Praxis Research Site

    La Jolla, Californiano site contact published

  • Praxis Research Site

    Gulf Breeze, Floridano site contact published

  • Praxis Research Site

    Chevy Chase, Marylandno site contact published

  • Praxis Research Site

    Roseville, Minnesotano site contact published

  • Praxis Research Site

    Hackensack, New Jerseyno site contact published

  • Praxis Research Site

    Philadelphia, Pennsylvaniano site contact published

  • Praxis Research Site

    Heidelberg, Victoria, Australiano site contact published

  • Praxis Research Site

    Rio Grande, Do Sul, Brazilno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Praxis Precision Medicines

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To assess the effect of relutrigine on seizure frequency in participants with DEEs compared to placebo16 weeks

    Change from baseline in monthly motor seizure frequency