NCT07225231Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 31 Oct 2025
- Start date
- 20 Apr 2026
- Primary completion date
- 28 Dec 2027
- Lead sponsor
- Byteflies
- Diseases
- Epilepsy
- NCT number
- NCT07225231
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 20 Apr 2026 to the primary completion date, 28 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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 known allergy or skin-sensitivity to the materials used in the Byteflies Adhesives
- 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
Age
- Are between 0 and 3 years of age;
Other
- 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.
- Are above weight allowing variable titration
Who the study is looking for
- 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.
Age in the registry: 3 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Child Neurology Consultants of Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Norton Children's Research Institute - University of Louisville School of Medicine Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| MultiCare Mary Bridge Children's Hospital and Health System Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.