Dravet Syndrome (DS)TETRISNCT07225231
Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS
A study testing Byteflies Remote patient monitoring solution (with reduced EEG) in people with Dravet Syndrome (DS) and Lennox Gastaut Syndrome (LGS), run by Byteflies at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
- What is being tested?
- Byteflies Remote patient monitoring solution (with reduced EEG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Apr 2026to 28 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 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.
- Have known allergy or skin-sensitivity to the materials used in the Byteflies Adhesives
- Are between 0 and 3 years of age;
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- Are above weight allowing variable titration
- 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
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Child Neurology & Consultants of Austin
Austin, Texas, 78749
Norton Children's Research Institute - University of Louisville School of Medicine
Louisville, Kentucky, 40202
MultiCare Mary Bridge Children's Hospital and Health System
Tacoma, Washington, 98405
About this study
Official title: 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
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.
- Being tested
- Byteflies Remote patient monitoring solution (with reduced EEG)
- Medical subject headings
- Epilepsies, Myoclonic, Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Byteflies Remote patient monitoring solution (with reduced EEG)Device
Remote patient monitoring (RPM) solution designed to collect EEG, ECG and EMG data.
| Study group | Role | What they receive |
|---|---|---|
| Patient treated with standard-of-care fenfluramine and wearing remote patient monitoring solution | Experimental | 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. Receives: Device: Byteflies Remote patient monitoring solution (with reduced EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician confidence in treatment decision-making using RPM data
The primary endpoint of the study is defined as the proportion of cases in which physicians report higher confidence in treatment decision-making when using RPM-enhanced data compared to standard care, with increased confidence defined as an RPM confidence score greater than the standard confidence score. The primary endpoint is considered successful if physicians demonstrate improved confidence in their treatment decisions for at least 50% of the patients when RPM data is available.
For each patient, the following assessments will be performed:
- Standard Decision (-RPM): Clinicians will determine the treatment plan based on routine data. Clinicians will record their confidence in this decision on a 1-5 Likert scale (1 = not confident, 5 = very confident).
- RPM-Enhanced Decision (+RPM): Clinicians will determine the treatment plan using the same routine data plus information provided by the RPM system. Clinicians will record their confidence in this decision on a 1-5 Likert scale.
Measured: At end of first RPM period (2 weeks after treatment start), at end of second RPM period (between 1 to 3 months after treatment start), at end of third RPM period (between 3 to 9 months after treatment start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start20 Apr 2026
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dravet Syndrome (DS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Byteflies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225231
- Sponsor's protocol ID
- BF0003
- Acronym
- TETRIS
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No