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

NCT07112365 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: HSC-MS-23-0940
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dravet Syndrome

Keywords

epilepsy; Sudden Unexpected Death in Epilepsy (SUDEP)

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, Day ~60

• Change in speed of cerebrovascular response to CO₂

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

  Baseline, Day ~60

Secondary Outcomes (1)

• Change in breathing response to CO₂

  Baseline, Day ~60

Study Arms (1)

Fintepla plus Hypercapnia Challenge using the Respiract Device

EXPERIMENTAL

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

Interventions

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.

Also known as: Fenfluramine

Fintepla plus Hypercapnia Challenge using the Respiract Device

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.

Also known as: RespirAct

Fintepla plus Hypercapnia Challenge using the Respiract Device

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Epilepsies, Myoclonic; Epilepsy; Sudden Unexpected Death in Epilepsy

Interventions

Fenfluramine

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Samden Lhatoo, MD, FRCP

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samden Lhatoo, MD, FRCP

CONTACT

(713) 500-7106; Samden.D.Lhatoo@uth.tmc.edu

Sandhya Rani

CONTACT

(713) 500-7499; M.R.Sandhya.Rani@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: April 27, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)