Studies brain blood flow changes from Fintepla in Dravet syndrome
Tests fenfluramine, Fintepla, in people with Dravet syndrome who have convulsive seizures.
Plain-language title generated from the registry record
Registry title: The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
Key facts
- Where
- Houston, United StatesSee the site
- Phase
- Phase 4
Where in United States
- The University of Texas Health Science Center at HoustonHouston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Texas Health Science Center, Houston
- Trial code
- NCT07112365
- Record updated
- 15 July 2026
- Original description
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.Read full original descriptionShow less
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.
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.
Inclusion: DS patients (with or without SCN1A pathogenic mutations); Generalized convulsive seizures.
Exclusion: on serotonergic medications, and/or; taken the following drugs within 14 days: monoamine oxidase inhibitors (MAOIs), anti-depressants (Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and norepinephrine reuptake inhibitors (SNRIs), and Tricyclic antidepressants (TCAs)), St. John's Wort, Tryptophan, and Dextromethorphan; known cardiorespiratory, hepatic or renal disease, and/or; allergic reactions or other contraindications to fenfluramine and/or; on Stiripentol treatment, and/or; contraindications to Midazolam anesthesia.