Remote Monitoring for Epilepsy

(TETRIS Trial)

Enrolling by invitation at 2 trial locations
NN
Overseen ByNathalie Niclaus
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Byteflies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

My neurologist decided Fenfluramine is right for me, and I have never taken it before.
I have Dravet or Lennox-Gastaut syndrome and can take Fenfluramine.
I am able and willing to keep a record of seizures.

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

Group I: Patient treated with standard-of-care fenfluramine and wearing remote patient monitoring solutionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Byteflies

Lead Sponsor

Trials
6
Recruited
860+

UCB Pharma

Industry Sponsor

Trials
345
Recruited
110,000+
Jean-Christophe Tellier profile image

Jean-Christophe Tellier

UCB Pharma

Chief Executive Officer since 2015

MD specialized in Rheumatology

Prof. Dr. Iris Löw-Friedrich profile image

Prof. Dr. Iris Löw-Friedrich

UCB Pharma

Chief Medical Officer since 2004

MD, PhD