NCT07112365RecruitingPhase 4
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 27 Apr 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Diseases
- Epilepsy
- NCT number
- NCT07112365
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 25
- From 27 Apr 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- known cardiorespiratory, hepatic or renal disease, and/or
- allergic reactions or other contraindications to fenfluramine and/or
Other
- on Stiripentol treatment, and/or
- contraindications to Midazolam anesthesia
Who the study is looking for
- DS patients (with or without SCN1A pathogenic mutations)
- Generalized convulsive seizures
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.