NCT07112365PHASE4Recruiting
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
The University of Texas Health Science Center, Houston
Start Date
4/27/2026
Completion Date
3/31/2028
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.
Eligibility Criteria
Age Range: 16 years to No maximum
Inclusion Criteria:
* DS patients (with or without SCN1A pathogenic mutations)
* Generalized convulsive seizures
Exclusion Criteria:
* 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
* contraindications to Midazolam anesthesia
* taken the following drugs within 14 days: monoamine oxidase inhibitors (MAOIs), anti-depressants (Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and norepinephrine reuptake inhibitors (SNRIs), and Tricyclic antidepressants (TCAs)), St. John's Wort, Tryptophan, and Dextromethorphan
Interventions
DRUG
Fenfluramine treatment (Fintepla)
DEVICE
Hypercapnia Challenge using the device (RespirAct)
Conditions
Dravet Syndrome
Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States