retrospective-prospective cohort study to observe Safinamide safety
Research type
Research Study
Full title
European multicenter retrospective-prospective cohort study to observe Safinamide safety profile and pattern of use in clinical practice during the first postcommercialization phase–Study Z7219N02
IRAS ID
140502
Contact name
Camille Carroll
Contact email
Sponsor organisation
Zambon S.p.A.
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Safinamide is an EU market product (2015), it is indicated as add-on therapy for the treatment of patients with idiopathic Parkinson’s Disease (PD). During the initial marketing authorization procedure, at day 180 the European Medicines Agency (EMA) recommended to the Applicant to provide additional real world data on Safinamide given the uncertainties regarding categories of patients not well represented in clinical trials, namely patients aged > 75 years and those with concomitant psychiatric conditions such as psychosis, cognitive dysfunction and depression.
The observational study will be conducted in patients aged >18 years and with relevant concomitant conditions in relevant hospitals/NHS trust. Data will be prospectively recorded on the Study eCRF by the Investigator both by retrieving already available data from the medical charts and by interviewing the patient in order to collect information that, as per single centre practice, would not be reported in the patient’s medical chart.
The Investigator will be asked to report all the Adverse Events (serious or not, related or not to Safinamide) and pregnancy cases occurred during the observation period of which he/she becomes aware.
Data will be collected for 12 months after start of participant’s treatment with Safinamide.
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0600
Date of REC Opinion
16 Aug 2016
REC opinion
Favourable Opinion