drugset / Trial / NCT07112365

The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project

NCT07112365

NaSingle-groupOpen-labelPrevention

Summary

This study investigates cerebrovascular reactivity (CVR) and functional brain connectivity in Dravet Syndrome (DS) patients with convulsive seizures. Using functional MRI (fMRI), we will define differences in brain responses to CO₂ changes before administration of the drug Fintepla (Baseline), with a library of healthy controls and with those obtained after administration of Fintepla (Day \~60). Changes in CVR and their relation to ventilatory responses will also be assessed during fMRI.

Timeline

Start
2026-04-27
Primary completion
2027-09-30
Completion
2028-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenfluramine Small molecule 0.6 mg/kg

Indications