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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07112365
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Dravet Syndrome

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Fintepla plus Hypercapnia Challenge using the Respiract Device

Primary Outcome Measure

Change in blood oxygenation level in response to CO₂ [ Time Frame: Baseline, Day ~60 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Samden Lhatoo, MD, FRCP
[email protected]
(713) 500-7106
Sandhya Rani
[email protected]
(713) 500-7499

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