Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorByteflies
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Byteflies Remote patient monitoring solution (with reduced EEG)
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Byteflies
Lead sponsor
UCB Pharma
Collaborator
Source ClinicalTrials.gov