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NCT07112365 · ClinicalTrials.gov registry record · Phase 4
The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
- Not yet
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT07112365: Clinical Trial Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
NCT07112365 is a Phase 4 study that has not yet begun recruiting, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07112365, a Phase 4 study, has not yet begun recruiting, sponsored by The University of Texas Health Science Center, Houston.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study 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.
Primary Outcome
Measures how much blood oxygenation level dependent (BOLD) signal changes in response to CO₂, using fMRI.
Interventions
- DRUG Fenfluramine treatment (Fintepla)
- DEVICE Hypercapnia Challenge using the device (RespirAct)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-04 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 4 |
What is known before NCT07112365 opens enrollment
NCT07112365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Fenfluramine treatment (Fintepla) is the first listed.
NCT07112365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07112365 about?
NCT07112365 is a clinical study titled "The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project". 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 ...
What is the current status of trial NCT07112365?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2026-04. Estimated completion is 2028-03-31.
What interventions are being tested in trial NCT07112365?
The interventions under investigation include: Fenfluramine treatment (Fintepla) (DRUG), Hypercapnia Challenge using the device (RespirAct) (DEVICE).
Who is sponsoring clinical trial NCT07112365?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07112365's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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