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

Study acronym: FAST-DS
StatusRecruiting
PhasePhase 4
Started2026-04-27
View on ClinicalTrials.gov ↗

Amendment history

2026-07-13
Study Status, Contacts/Locations v2
Recruitment opened
Start dateestimated 2026-04→confirmed 2026-04-27
Study sitesdetails revised at 1 of 1 site
2026-03-31
Withheld→Not Yet Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v1
Trial statusWithheld→Not Yet Recruiting
Primary completion datenot stated→2027-09-30
Completion datenot stated→2028-03-31
Start datenot stated→2026-04
Lead sponsor[Redacted]→The University of Texas Health Science Center, Houston
Study title-1 characters
[TrialThe ofFINTEPLA deviceas thatan isAnti-SUDEP notTherapy approvedin orDravet clearedSyndrome by the U.S. FDA]Project
2025-08-01
Original filing
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.
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