The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:
• DS patients (with or without SCN1A pathogenic mutations)
• Generalized convulsive seizures
Locations
United States
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Samden Lhatoo, MD, FRCP
Samden.D.Lhatoo@uth.tmc.edu
(713) 500-7106
Backup
Sandhya Rani
M.R.Sandhya.Rani@uth.tmc.edu
(713) 500-7499
Time Frame
Start Date: 2026-04-27
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 25
Treatments
Experimental: Fintepla plus Hypercapnia Challenge using the Respiract Device
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston