Trials Today

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

Purpose

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

Condition

Developmental and Epileptic Encephalopathy 1

Eligibility

Eligible Ages: Between 2 Years and 65 Years
Eligible Sex: All
Accepts 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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part A: Double-Blind Treatment Period	Eligible participants will be randomly assigned in a double-blind manner and a 1:1 ratio to receive 1.0mg-1.5mg/kg relutrigine or placebo once daily orally or gastronomy/jejunostomy for 16 weeks	Drug: 1.0mg/kg/day PRAX-562 Once daily orally or gastronomy/jejunostomy Other names: relutrigine Drug: 1.5mg/kg/day PRAX-562 Once daily orally or gastronomy/jejunostomy Drug: Placebo Once daily orally or gastronomy/jejunostomy
Placebo Comparator Part A: Double-Blind Treatment Period (Placebo)	Eligible participants will be randomly assigned in a double-blind manner and a 1:1 ratio to receive 1.0mg-1.5mg/kg relutrigine or placebo once daily orally or gastronomy/jejunostomy for 16 weeks	Drug: Placebo Once daily orally or gastronomy/jejunostomy
Experimental Part B: Open-Label Extension Treatment Period	Participants from Part A will have the option to rollover to Part B to receive 1.0mg-1.5mg/kg of relutrigine once daily orally or gastronomy/jejunostomy for 32 weeks	Drug: 1.0mg/kg/day PRAX-562 Once daily orally or gastronomy/jejunostomy Other names: relutrigine Drug: 1.5mg/kg/day PRAX-562 Once daily orally or gastronomy/jejunostomy

Recruiting Locations

Praxis Research Site
Chevy Chase, Maryland 20815

More Details

NCT ID: NCT07010471
Status: Recruiting
Sponsor: Praxis Precision Medicines

Study Contact

Head of Pharmacovigilance
617-300-8460
clinicaltrials@praxismedicines.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.