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The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
Sponsor: The University of Texas Health Science Center, Houston
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.
Official title: The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-04
Completion Date
2028-03-31
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Fenfluramine treatment (Fintepla)
Participants will receive Fintepla starting at 0.2 mg/kg/day, up to a maximum of 0.6 mg/kg/day (or 5.9 mL/day, whichever is lower), per FDA guidelines. Dosing will be adjusted as tolerated. After Day \~60, the dose will be gradually tapered.
Hypercapnia Challenge using the device (RespirAct)
Participants will undergo a hypercapnia challenge using the RespirAct device during fMRI. The protocol includes alternating one minute blocks of controlled CO₂ increases and normocapnia under normoxic conditions.
Locations (1)
The University of Texas Health Science Center at Houston
Houston, Texas, United States