NCT07112365

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

The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

• Dravet Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-09-30
• Completion: 2028-03-31
• First posted: 2025-08-08
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study