Recruiting

Fintepla

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07112365

Conditions

Dravet Syndrome

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Fenfluramine treatment (Fintepla)

Hypercapnia Challenge using the device (RespirAct)

Study Details

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

Study ID

NCT07112365

Start date

Apr 27, 2026

Status verified date

Jul, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Fintepla plus Hypercapnia Challenge using the Respiract Device

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Samden Lhatoo, MD, FRCP

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

Sandhya Rani

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Samden Lhatoo, MD, FRCP

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

Sandhya Rani

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • epilepsy
  • Sudden Unexpected Death in Epilepsy (SUDEP)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-07-15.