Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Byteflies
With
UCB Pharma
Age
3–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
