The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
Recruiting · NCT07112365 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Texas Health Science Center, Houston
View the official record on ClinicalTrials.gov →Interventions studied
Fenfluramine treatment (Fintepla)Hypercapnia Challenge using the device (RespirAct)
What this trial is about
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.
Who can take part
Age range
16 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- The University of Texas Health Science Center at Houston - Houston, Texas, United States