Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Praxis Precision Medicines
Age
2–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
