Clinical Trial

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

Study acronym: FAST-DS
Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-16
Trial Details
NCT Number NCT07112365
Lead Sponsor The University of Texas Health Science Center, Houston
Conditions Dravet Syndrome
Enrollment 25 participants
Start Date 2026-04-27
Primary Completion 2027-09-30 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-15