drugset / Trial / NCT07112365
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2026-04-27
- Primary completion
- 2027-09-30
- Completion
- 2028-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fenfluramine | Small molecule | 0.6 mg/kg | — |