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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Developmental and Epileptic Encephalopathy 1

In brief

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

Key facts

Study ID

NCT07010471

Run by

Praxis Precision Medicines

People needed

160

Starts

2025-07-09

Expected to finish

2027-11-01

Last updated by the study team

2026-08-04

Who can join

Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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