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Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS

NCT07225231 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-06

No results posted yet for this study

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

DEVICE

Byteflies Remote patient monitoring solution (with reduced EEG)

Remote patient monitoring (RPM) solution designed to collect EEG, ECG and EMG data.

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Byteflies

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225231 on ClinicalTrials.gov