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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Byteflies Remote patient monitoring solution (with reduced EEG) | Device | Remote patient monitoring (RPM) solution designed to collect EEG, ECG and EMG data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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) |
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Inclusion Criteria:
Exclusion Criteria: Patients who
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Niclaus | Contact | +32 474381323 | nathalie.niclaus@byteflies.com |
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| ID | Term |
|---|---|
| D004831 | Epilepsies, Myoclonic |
| D065768 | Lennox Gastaut Syndrome |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 |
| Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |