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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

Qualifiers

DS patients (with or without SCN1A pathogenic mutations)

Generalized convulsive seizures

Disqualifiers

known cardiorespiratory, hepatic or renal disease, and/or

allergic reactions or other contraindications to fenfluramine and/or

on Stiripentol treatment, and/or

on serotonergic medications, and/or

Trial design

Treatments tested in this trial

  • Fenfluramine treatment (Fintepla)
  • Hypercapnia Challenge using the device (RespirAct)

Treatment groups

25 Participants
are divided into 1 treatment group