Menu
Recruiting NCT07112365

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

Phase IV Interventional Dravet Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fenfluramine treatment (Fintepla), Hypercapnia Challenge using the device (RespirAct).
Who it may be relevant to
Registry conditions: Dravet Syndrome. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Change in blood oxygenation level in response to CO₂ [Time frame: Baseline, Day ~60]
  • Change in speed of cerebrovascular response to CO₂ [Time frame: Baseline, Day ~60]
Secondary outcome measures (1)
  • Change in breathing response to CO₂ [Time frame: Baseline, Day ~60]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07112365 · HSC-MS-23-0940

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗