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

RecruitingPhase 4Ages 16 Years - anyAllThe University of Texas Health Science Center, Ho…
NCT07112365 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Fenfluramine treatment (Fintepla)
  • Hypercapnia Challenge using the device (RespirAct)
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Where

1 site
The University of Texas Health Science Center at Houston
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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