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The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.
Who can join
Ages 16 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * DS patients (with or without SCN1A pathogenic mutations) * Generalized convulsive seizures Exclusion Criteria: * 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
About the study
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.
What is being tested
- Fenfluramine treatment (Fintepla) (drug)
- Hypercapnia Challenge using the device (RespirAct) (device)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 25 · Started: Apr 27, 2026
Contact the study team
- Samden Lhatoo, MD, FRCP · Phone: (713) 500-7106
- Sandhya Rani · Phone: (713) 500-7499
Official record on ClinicalTrials.gov — NCT07112365
Locations in the U.S.
| Texas | The University of Texas Health Science Center at Houston, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.