Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol) (NCT04437004) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)
United States
Plain-language summary
The purpose of this research study is to (1) provide access to fenfluramine for patients with intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of fenfluramine.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since fenfluramine has already been approved for marketing for Dravet Syndrome, can you explain how getting it through this expanded access protocol differs from simply receiving it as a standard prescription, and which path makes more sense for my situation?
2Given that fenfluramine was historically associated with heart valve problems when used as a diet drug, what cardiac monitoring would be involved if I were to use it for Dravet Syndrome, and how often would my heart need to be checked?
3How does fenfluramine compare to the other seizure medications I'm already on or could try, and is there a reason to consider this over adjusting my current treatment plan?
4Are there specific features of my Dravet Syndrome — like my seizure frequency, genetic confirmation, or age — that would make fenfluramine a stronger or weaker option for me compared to other patients?
5If I started fenfluramine and it didn't work well or caused side effects, what would the process look like for stopping it safely and moving on to another approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.