Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07112365
The ClinicalTrials.gov registry entry for NCT07112365 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fenfluramine treatment (Fintepla) is the first listed.
NCT07112365 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.