A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-65
SponsorPraxis Precision Medicines
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 1.0mg/kg/day PRAX-562
- 1.5mg/kg/day PRAX-562
- Placebo
Treatment groups
160 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov