Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07112365

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dravet Syndrome Brain Diseases Central Nervous System Diseases Death Death, Sudden Epilepsies, Myoclonic Epilepsy Epilepsy, Generalized Epileptic Syndromes Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Unexpected Death in Epilepsy

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fenfluramine treatment (Fintepla)

Drug

Participants will receive Fintepla starting at 0.2 mg/kg/day, up to a maximum of 0.6 mg/kg/day (or 5.9 mL/day, whichever is lower), per FDA guidelines. Dosing will be adjusted as tolerated. After Day ~60, the dose will be gradually tapered.

Other names: Fenfluramine

Hypercapnia Challenge using the device (RespirAct)

Device

Participants will undergo a hypercapnia challenge using the RespirAct device during fMRI. The protocol includes alternating one minute blocks of controlled CO₂ increases and normocapnia under normoxic conditions.

Other names: RespirAct

Primary outcomes

  1. Change in blood oxygenation level in response to CO₂

    Time frame: Baseline, Day ~60

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

  2. Change in speed of cerebrovascular response to CO₂

    Time frame: Baseline, Day ~60

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

Secondary outcomes

  1. Change in breathing response to CO₂

    Time frame: Baseline, Day ~60

    Assesses how the participant's breathing rate changes when CO₂ levels are increased.

Study contacts

Contact information is provided by the study sponsor or research team.

Samden Lhatoo, MD, FRCP

CONTACT

[email protected]

(713) 500-7106

Sandhya Rani

CONTACT

[email protected]

(713) 500-7499

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Acronym: FAST-DS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 8, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.