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

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