Last updated 2 months ago
A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
160 patients around the world
Available in United States, Brazil
Praxis Precision Medicines
160Patients around the world
This study is for people with
Epileptic Encephalopathies
Epileptic Encephalopathies and Developmental Epilepsies (DEE)
Requirements for the patient
To 65 Years
All Gender
Medical requirements
- 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.
- 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.
StudyEMERALD
SponsorPraxis Precision Medicines
Study typeInterventional
Conditions
Epileptic Encephalopathies and Developmental Epilepsies (DEE)
Requirements
To 65 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07010471
