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Fintepla for Dravet Syndrome and Brain Response to CO2

This study is looking at how the brain responds to changes in carbon dioxide (CO2) in people with Dravet Syndrome (DS), a severe form of epilepsy. Researchers will use a drug called Fintepla (fenfluramine) and a device called RespirAct, which helps control CO2 levels during an fMRI (functional MRI) scan. The goal is to see if Fintepla changes how the brain's blood flow reacts to CO2. You might be able to join if you are 16 or older, have Dravet Syndrome with convulsive seizures, and don't have certain heart, lung, liver, or kidney problems. The study will measure changes in blood oxygen levels and the speed of brain responses to CO2 at the beginning and after about 60 days of Fintepla treatment. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 25 participants. It will compare brain responses before and after Fintepla treatment.
What's involved
You would receive Fintepla treatment, with the dose adjusted over time. You would also undergo a hypercapnia challenge using the RespirAct device during fMRI at the start of the study and again after about 60 days.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements are taken at the beginning of the study and after approximately 60 days of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07112365

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

Recruiting
PHASE4Ages 16+InterventionalPrevention
The University of Texas Health Science Center, Houston
~25 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Fenfluramine treatment (Fintepla)Hypercapnia Challenge using the device (RespirAct)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in blood oxygenation level in response to CO₂
Measured over Baseline, Day ~60
+1 more outcome measured

Conditions

Dravet Syndrome

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Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Samden Lhatoo, MD, FRCP · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Samden Lhatoo, MD, FRCP
[email protected]
(713) 500-7106
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

DS patients (with or without SCN1A pathogenic mutations)
Generalized convulsive seizures

Exclusion

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

What this trial measures

  • Change in blood oxygenation level in response to CO₂Baseline, Day ~60

    Measures how much blood oxygenation level dependent (BOLD) signal changes in response to CO₂, using fMRI.

  • Change in speed of cerebrovascular response to CO₂Baseline, Day ~60

    Measures how quickly the brain responds to CO₂ exposure during fMRI.