Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS (NCT07225231) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS
20 participantsStarted 2025-12-15
Plain-language summary
The goal of this real world data study is to evaluate the clinical utility of remote patient monitoring solution (using Byteflies' EpiCare@Home with reduced EEG montage and other vital signs) with Dravet and LGS patients (ages 3 and up with the exclusion of adults above weight allowing variable titration) to identify an optimal Fenfluramine treatment.
Patients will wear one or more small portable and medically certified measuring devices. Through these devices, electroencephalography (EEG) signals, as well as electro-cardiography (ECG), heart rate, respiration rate, and physical activity are measured, which allows the patient's physician to detect potential seizures, and thus gain more insights.
Participants will be asked to wear the devices three times at home for remote monitoring periods lasting between 3 and 7 consecutive days. The duration of each monitoring period will be determined by the physician based on the type of epilepsy and the frequency of seizures.
Who can participate
Age range
3 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:
* Patients with a confirmed Dravet syndrome or Lennox-Gastaut syndrome diagnosis who are eligible for Fenfluramine.
* Patients for which the neurologist decided to prescribe Fenfluramine as a relevant treatment approach and who have not been prescribed Fenfluramine before.
* Patients or caregivers should be able and willing to maintain a seizure diary e.g. using a digital seizure diary.
Exclusion Criteria: Patients who
* Have been diagnosed with or are suspected to have life-threatening conditions that could result in immediate danger;
* Need to undergo an MRI scan or cardiac defibrillation;
* Have an active implanted device such as a pacemaker, defibrillator, or vagal nerve, or brain stimulator;
* Are unable to provide written informed consent, either directly or via a legal guardian.
* Have known allergy or skin-sensitivity to the materials used in the Byteflies Adhesives
* Are between 0 and 3 years of age;
* Are above weight allowing variable titration
* The patient is on any medication that would be contra-indicated for use with Fenfluramine at the execution of the study eg. LP352 (bexicaserin), loracaserin, monoamine-oxidase inhibitors, SSRIs, SNRIs, tricyclic antidepressants or other serotonergic agonists or antagonists (antipsychotics).
* Have a prescribed concomitant use of Stiripentol
* Have any other condition or finding that would compromise the safety of the participant or the quality of the data, or otherwise interfere with achieving the ob…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Physician confidence in treatment decision-making using RPM data
Timeframe: At end of first RPM period (2 weeks after treatment start), at end of second RPM period (between 1 to 3 months after treatment start), at end of third RPM period (between 3 to 9 months after treatment start)