The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
Recruiting now · Phase 4
Conditions studied: Dravet Syndrome
In brief
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.
Key facts
- Study ID
- NCT07112365
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 25
- Starts
- 2026-04-27
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2026-07-15
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- DS patients (with or without SCN1A pathogenic mutations)
- Generalized convulsive seizures
You may not qualify if…
- known cardiorespiratory, hepatic or renal disease, and/or
- allergic reactions or other contraindications to fenfluramine and/or
- on Stiripentol treatment, and/or
- on serotonergic medications, and/or
- contraindications to Midazolam anesthesia
- 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
Where it is running
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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