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Wearable EEG gadget aims to perfect seizure drug dosing at home

NCT ID NCT07225231

Knowledge-focused Sponsor: Byteflies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a wearable device that records brain waves, heart rate, and movement at home can help doctors better adjust the dose of the seizure drug fenfluramine for people with Dravet syndrome or Lennox-Gastaut syndrome. Twenty patients will wear the device for 3-7 days at a time, three times total. Doctors will compare their confidence in dosing decisions with and without the home monitoring data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fenfluramine
What this could lead to
If successful, this could show that home EEG monitoring helps doctors fine-tune fenfluramine dosing more confidently for Dravet and Lennox-Gastaut patients.
What could go wrong
This is a very small early study (20 people) that only measures doctor confidence, not patient outcomes. It may not prove that home monitoring actually improves seizure control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: Patients who * 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; * 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

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Conditions

The condition(s) this trial relates to.

Dravet syndrome Epilepsies, Myoclonic Lennox-Gastaut syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dravet syndrome (DS) Lennox-Gastaut syndrome (LGS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.