Remote Monitoring for Epilepsy
(TETRIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for children (age 3 and up) with Dravet syndrome or Lennox-Gastaut syndrome who are starting Fenfluramine treatment for the first time. Participants or their caregivers must be able to keep a seizure diary.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Byteflies Remote patient monitoring solution (with reduced EEG)
Trial Overview
The study tests if using a wearable home monitoring device that records brain activity (EEG), heart rate, breathing, and movement can help doctors better adjust Fenfluramine doses in patients with severe epilepsy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive standard-of-care fenfluramine treatment as prescribed for their clinical condition. In addition, they will be equipped with a remote patient monitoring (RPM) solution designed to collect EEG, ECG and EMG data.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Byteflies
Lead Sponsor
UCB Pharma
Industry Sponsor
Jean-Christophe Tellier
UCB Pharma
Chief Executive Officer since 2015
MD specialized in Rheumatology
Prof. Dr. Iris Löw-Friedrich
UCB Pharma
Chief Medical Officer since 2004
MD, PhD
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