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

ConditionDravet Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

DS patients (with or without SCN1A pathogenic mutations)

Generalized convulsive seizures

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Fintepla plus Hypercapnia Challenge using the Respiract DeviceExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in blood oxygenation level in response to CO₂

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

Time frame
Baseline, Day ~60
2

Change in speed of cerebrovascular response to CO₂

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

Time frame
Baseline, Day ~60

Secondary outcomes

1

Change in breathing response to CO₂

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

Time frame
Baseline, Day ~60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov
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