ClinicalTrials.gov record NCT07112365

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.
Age16 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 4 study uses fMRI and controlled CO₂ (hypercapnia) challenges to measure brain blood-vessel responses and breathing in people with Dravet Syndrome. Participants are scanned before starting Fintepla and again around Day ~60 after treatment, and results are compared with a library of healthy controls. The study also looks at functional brain connectivity and how blood-vessel responses relate to breathing.

What it is studying. It tests how fenfluramine (Fintepla) affects cerebrovascular reactivity — the size and speed of blood-oxygenation responses — and related breathing responses during controlled CO₂ challenges, measured by fMRI before and about 60 days after starting treatment.

What the researchers hope to learn. To describe cerebrovascular reactivity (how brain blood flow and oxygenation respond to CO₂) and functional brain connectivity in Dravet Syndrome; to measure changes in these signals after fenfluramine treatment; and to assess the relationship between cerebrovascular responses and ventilatory (breathing) responses.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have functional MRI (fMRI) scans at baseline and around Day ~60 while undergoing a hypercapnia challenge (controlled CO₂ increases and periods of normal CO₂) using the RespirAct device. They will start fenfluramine (Fintepla) at 0.2 mg/kg/day with dose adjustments up to 0.6 mg/kg/day (or 5.9 mL/day, whichever is lower) as tolerated, and the dose will be gradually tapered after about Day ~60. Breathing responses will be measured during the fMRI; the registry record does not list further visit schedules or routine tests in detail.

How the study is structured. Open-label, single-group interventional study (Phase 4). All participants receive fenfluramine per the stated dosing schedule and undergo hypercapnia challenges with the RespirAct device during fMRI at baseline and at about Day ~60. There is no masking; measurements are compared before versus after treatment and against a healthy-control library.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Dravet Syndrome. Does it apply to my diagnosis?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on CDKL5 deficiency disorder

This trial is also listed on this site under Dravet syndrome.

Clinical trials22 trials listed for CDKL5 deficiency disorderEvery trial the registry lists for CDKL5 deficiency disorder, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in CDKL5 deficiency disorder researchLatest monthly update: September 2026. Includes: EEG background changes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Apr 27, 2026
Primary completion
Sep 30, 2027 (estimated)
Study completion
Mar 31, 2028 (estimated)
Target enrollment
25 participants (estimated)
Last updated on registry
Jul 15, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
The University of Texas Health Science Center, Houston
Principal investigator
Samden Lhatoo, Professor
The University of Texas Health Science Center, Houston

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials