The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
Recruiting
Phase 4
Interventional Study
Dravet Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 25 (estimated)
- Sponsor
- The University of Texas Health Science Center, Houston · Other
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About This Trial
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). C…
Trial Locations
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Eligibility Criteria
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/o…
Contacts