ClinicalTrials.gov record NCT07225231
Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS
Byteflies Real-world Data Study: Assessing the Clinical Utility of Reduced EEG Montage Home Monitoring for Clinician-driven Fenfluramine Titration in Dravet Syndrome and Lennox-Gastaut Syndrome
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This interventional study tests a small wearable remote monitoring system that records reduced‑montage EEG plus ECG and other vital signs while people start fenfluramine. It is for people with Dravet syndrome or Lennox‑Gastaut syndrome who are beginning fenfluramine treatment. Participants wear the devices at home for three monitoring periods of 3–7 consecutive days each while their clinicians record treatment decisions with and without the remote data.
What it is studying. The study is testing whether remote patient monitoring (a reduced EEG montage plus ECG, heart rate, breathing rate, and activity) gives clinicians more confidence when making fenfluramine treatment decisions during titration. Clinicians will compare their confidence in decisions made with routine information versus with the additional remote monitoring data.
What the researchers hope to learn. Scientific goals: measure whether clinicians report higher confidence in treatment decisions when they have remote monitoring data versus routine data, and collect remote EEG/ECG/physiologic recordings during fenfluramine titration. The primary success threshold is improved clinician confidence for at least 50% of patients.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- Byteflies Remote patient monitoring solution (with reduced EEG)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 objectives.
- A history of cardiovascular or cerebrovascular disease, aortic or mitral valve regurgitation diagnosed by echography
- Patients/caregivers who have only reported/detected non-motor seizures
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive standard‑of‑care fenfluramine as prescribed and will wear small portable medically certified monitoring devices that record reduced EEG plus ECG, heart rate, breathing and activity. They will be asked to wear the devices on three at‑home monitoring periods, each lasting 3 to 7 consecutive days, with the exact timing and length set by the treating physician. Clinicians will review routine data with and without the remote monitoring data and record their confidence in treatment decisions at three timepoints (about 2 weeks, 1–3 months, and 3–9 months after starting treatment). Participants must keep a seizure diary; no invasive procedures (for example spinal taps or biopsies) are listed in the registry record.
How the study is structured. This is a single-group, open (non‑masked) interventional study. All participants receive standard-of-care fenfluramine as prescribed and are given a Byteflies remote patient monitoring device to wear at home. Each participant will complete three home monitoring periods (each 3–7 consecutive days) at physician-determined times during the titration and follow-up. Clinicians will record their treatment plan and rate their confidence first using routine data and then again using the RPM data at specified timepoints (about 2 weeks, 1–3 months, and 3–9 months after treatment start).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Dravet syndrome
This trial is also listed on this site under CDKL5 deficiency disorder.
Important dates
- Study start
- Apr 20, 2026
- Primary completion
- Dec 28, 2027 (estimated)
- Study completion
- Feb 28, 2028 (estimated)
- Target enrollment
- 20 participants (estimated)
- Last updated on registry
- Oct 8, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Byteflies
- Collaborators
- UCB Pharma
Participating sites (3)
- Norton Children's Research Institute - University of Louisville School of Medicine
Louisville, Kentucky, 40202 · United States
- Child Neurology & Consultants of Austin
Austin, Texas, 78749 · United States
- MultiCare Mary Bridge Children's Hospital and Health System
Tacoma, Washington, 98405 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- ECG
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- legal guardian
- A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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