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)
To assess the effect of relutrigine on seizure frequency in participants with DEEs compared to placebo — 16 weeks Change from baseline in monthly motor seizure frequency
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.
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