WAKIX PASS -Post Authorisation Safety Study
Research type
Research Study
Full title
A 5-year multi-center, observational post-authorization safety study to document the utilisation of Wakix® in the treatment of narcolepsy with or without cataplexy and to collect information on its long-term safety when used in routine medical practice
IRAS ID
215870
Contact name
John O'Reilly
Contact email
Sponsor organisation
Bioprojet
Clinicaltrials.gov Identifier
ENCEPP/SDPP/13818 , EU PAS register number
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Wakix PASS is a non-interventional, prospective study on a pitolisant, named Wakix®. This drug is used to treat patients suffering from narcolepsy with or without cataplexy. The study aims to collect information on the long-term safety of Wakix® when used in a real-life setting and to document the drug utilisation patterns in routine medical practice. It follows a request by the European agency responsible for approving medicines (EMA) to monitor Wakix® in routine conditions of use and particularly its long-term safety. The sponsor study is Bioprojet Pharma,the licence holder of Wakix®. The study will take place in centres specialised in sleep disorders in the UK, France, Italy and Germany.\n\nPatients suffering from narcolepsy and who meet the study eligibility criteria will be able to\nparticipate after giving their written consent. The patients will be prescribed Wakix® according to standard clinical care. If they agree to take part in the study, the investigator will complete a questionnaire through the study e-CRF and patients will be invited to complete a paper questionnaire. Data will be obtained from patients at routine patient visits to investigators. The current practice is about a minimum of 1 visit per year. It is expected to enrol a total of 300 patients.\n
REC name
North West - Preston Research Ethics Committee
REC reference
17/NW/0143
Date of REC Opinion
2 May 2017
REC opinion
Further Information Favourable Opinion