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
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