Tapestry
Research type
Research Study
Full title
A Registry of Patient treated with Fintepla.
IRAS ID
329739
Contact name
Christin Eltze
Contact email
Sponsor organisation
UCB Biopharma
Clinicaltrials.gov Identifier
275888, Parexel Ref
Duration of Study in the UK
9 years, 7 months, 30 days
Research summary
To further improve medical care, it is very important to get scientific information about the safety and efficacy of drugs.
This includes the drug for the treatment of Dravet syndrome, a form of childhood epilepsy.
Tapestry is a post-authorisation safety study collecting data from a registry of patients treated with Fintepla.
The purpose of this NIS is to collect medical information about the safety of long-term utilization of Fintepla® including its risk of heart diseases, hypertension and low growth rate. The frequency of echocardiogram monitoring of participants will be collected.
It will be conducted at centers prescribing fenfluramine in routine practices for patients (new users or current users)2years and above. The study will involve neuro-pediatricians, neurologists and pediatricians.
The registry is planned to last ten years from the first patient first visit to the last patient last visit. The enrolment period will begin from the registry start date in the first participating country and span over three years, the maximum follow-up period for the last patient enrolled in the registry will be seven years, and the maximum follow-up period will be ten years for the first patient enrolled. Participants 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.REC name
London - Dulwich Research Ethics Committee
REC reference
23/PR/0885
Date of REC Opinion
4 Dec 2023
REC opinion
Further Information Favourable Opinion