The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
NCT07112365 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-04-03
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.
Conditions
Interventions
- DRUG
-
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.
- DEVICE
-
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.
Sponsors & Collaborators
-
The University of Texas Health Science Center, Houston
lead OTHER
Principal Investigators
-
Samden Lhatoo, MD, FRCP · The University of Texas Health Science Center, Houston
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2027-09-30
- Completion
- 2028-03-31
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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