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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Byteflies
Study ID
NCT07225231
Status
Enrolling By Invitation

Conditions

  • Dravet Syndrome (DS)
  • Lennox Gastaut Syndrome (LGS)

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Byteflies Remote patient monitoring solution (with reduced EEG) — DEVICE
    Remote patient monitoring (RPM) solution designed to collect EEG, ECG and EMG data.

Study Details

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.

Key Dates

First listed
Nov 6, 2025
Start date
Apr 20, 2026
Status verified
Oct 2026
Primary completion
Dec 28, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Patient treated with standard-of-care fenfluramine and wearing remote patient monitoring solution
    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.

Primary Outcome Measure

Physician confidence in treatment decision-making using RPM data [ Time Frame: 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) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Norton Children's Research Institute - University of Louisville School of MedicineLouisvilleKentucky40202-
Child Neurology & Consultants of AustinAustinTexas78749-
MultiCare Mary Bridge Children's Hospital and Health SystemTacomaWashington98405-

Find similar trials in Louisville, KY

By research site
Norton Children's Research Institute - University of Louisville School of Medicine· Louisville, KYChild Neurology & Consultants of Austin· Austin, TXMultiCare Mary Bridge Children's Hospital and Health System· Tacoma, WA

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