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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Byteflies · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dravet Syndrome (DS)
• Lennox Gastaut Syndrome (LGS)

Interventions

Type	Name	Description
DEVICE	Byteflies Remote patient monitoring solution (with reduced EEG)	Remote patient monitoring (RPM) solution designed to collect EEG, ECG and EMG data.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-11-06
• Last updated: 2025-11-06

Regulatory

• FDA-regulated device study