A Registry of Patient treated with Fintepla (Tapestry)

Research summary

This is a post authorization safety study of patients treated with fenfluramine hydrochloride oral solution, conducted at centers prescribing fenfluramine in routine practice. This study will involve neuro-pediatrician's, pediatricians, or neurologists – with experience in the treatment of epilepsy in both European (Germany, Austria, Denmark, Italy, UK, Spain and France) and non-European countries (potentially including US and Japan). The study will last for 10years for first patient first visit with enrollment period spanning over 3years from registry start date. The maximum follow-up period for the last patient will be 7-years while the maximum follow-up period for the first patient will be 10years. Participation of each patient in the registry will begin at cohort enrolment (Day 0), and the patient will be followed for up to six months after discontinuation of fenfluramine treatment, loss to follow-up, death, or end of the study period, whichever occurs first. Two group of patients will be included in the registry: - incident users (new users) - prevalent users (current users)

Principal Investigator

Mario Sa

Contact us

Email: childrensresearch@ouh.nhs.uk

IRAS number

329739