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Clinical Trials in the USA / NCT07010471
Active, not recruiting Phase 3

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

NCT07010471 · tracked via the Priya Life Science USA tracker
Sponsor
Praxis Precision Medicines
Phase
Phase 3
Started
2025-07-09
Last updated
2026-08-04

Condition(s) studied

Developmental and Epileptic Encephalopathy 1

Investigational drug(s) / intervention(s)

1.0mg/kg/day PRAX-5621.5mg/kg/day PRAX-562Placebo

1.0mg/kg/day PRAX-562: Once daily orally or gastronomy/jejunostomy

1.5mg/kg/day PRAX-562: Once daily orally or gastronomy/jejunostomy

Placebo: Once daily orally or gastronomy/jejunostomy

Study 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

Sex
ALL
Min age
2 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Praxis Research Site La Jolla California
Praxis Research Site Gulf Breeze Florida
Praxis Research Site Chevy Chase Maryland
Praxis Research Site Roseville Minnesota
Praxis Research Site Hackensack New Jersey
Praxis Research Site Philadelphia Pennsylvania
Praxis Research Site Heidelberg Victoria
Praxis Research Site Rio Grande Do Sul
Praxis Research Site Paraná Brazil
Praxis Research Site Rio de Janeiro Brazil
Praxis Research Site São Paulo Brazil

More Praxis Precision Medicines trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07010471 on ClinicalTrials.gov ↗ ← All trials in the USA