Fintepla for Dravet Syndrome: testing brain blood flow and connections
Official title: The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.
Run by The University of Texas Health Science Center, Houston · NCT07112365 · Data updated 2026-11-12
This study tests how Fintepla affects brain blood flow and network connections in Dravet syndrome patients who have convulsive seizures.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | April 27, 2026 |
| Main results expected | September 30, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | July 15, 2026 |
| Trial ID | NCT07112365 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with Dravet syndrome who experience generalized convulsive seizures and can tolerate hypercapnia testing and imaging.
✕Probably not a fit
Patients with significant cardiorespiratory, hepatic, renal disease, certain drug contraindications, or those on specific serotonergic or MAOI therapies may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 4 interventional study uses functional MRI to measure cerebrovascular reactivity and brain connectivity in Dravet syndrome patients before and after Fintepla treatment. Participants undergo a hypercapnia challenge to assess brain responses to CO2 and ventilatory changes, with comparisons to healthy controls and to post-treatment data around day 60. The goal is to understand how Fintepla may influence brain function related to seizures and SUDEP risk. Safety considerations include anesthesia with midazolam and exclusions for certain medical and drug contraindications.
Why it matters
Potential benefit: If successful, the study could clarify how Fintepla modulates brain function in Dravet syndrome and potentially reduce SUDEP risk or improve seizure-related outcomes.
How similar studies have gone: Previous studies in related epilepsy populations have used fMRI and hypercapnia to study brain physiology, but this exact combination with Fintepla in Dravet syndrome is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Samden Lhatoo, MD, FRCP — The University of Texas Health Science Center, Houston
- Study coordinator: Samden Lhatoo, MD, FRCP
- Email: Samden.D.Lhatoo@uth.tmc.edu
- Phone: (713) 500-7106
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ION337 safety and tolerability in children with Dravet syndrome
This will test whether ION337 is safe and well tolerated in children ages 2 to 12 with Dravet syndrome.
-
Tracking development, seizures, and biomarkers over four years in children and young adults with SCN1A-related Dravet syndrome
This project will follow children and young people with SCN1A-related Dravet syndrome for four years to see how their development, seizure patterns, and blood metabolite markers change over time.
-
PET‑MRI mapping of brainstem serotonin pathways in adults with Dravet syndrome
This uses a PET‑MRI scan with the tracer [18F]MPPF to see if serotonin pathways in the brainstem differ in adults with Dravet syndrome compared with healthy controls.
-
Testing BMB-101 for Absence Epilepsy and Related Conditions
This study is testing a new treatment called BMB-101 to see if it can help reduce seizures in people with Absence Epilepsy and related conditions.
-
Measuring GABA Levels in Children with Dravet Syndrome
This study is trying to measure GABA levels in the brains of children with Dravet Syndrome to see how they compare to kids without the condition, hoping to find new ways to understand and treat the syndrome.
-
Evaluating ETX101 for treating Dravet syndrome in young children
This study is testing a new treatment called ETX101 to see if it can help reduce seizures in young children with Dravet syndrome.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.