Status: Ongoing First registered on: 16/06/2016
Last updated on: 10/08/2020
1. Study identification
EU PAS Register NumberEUPAS13818
Official titleA 5-year multi-center, observational post-authorization safety study to document the drug utilisation of Wakix® in the treatment of narcolepsy with or without cataplexy and to collect information on its long termthe safety of Wakix® when used in routine medical practice
Study title acronymWAKIX PASS
Study typeObservational study
Brief description of the studyInternational, multi-center, non-interventional, prospective, open-label long-term post-authorization safety study (PASS) on the use of Wakix (pitolisant) a new H3R antagonist approved for the treatment of narcolepsy with or without cataplexy in adults. The patients will be observed during routine clinical practice. Study is planned to follow up patients for five years or to the end of the study. The product (Wakix)will be prescribed and used based on the routine clinical practice as well as on the individual situation of each patient and according to the approved SPC. The main objectives are to collect information on the long term safety of pitolisant Wakix® (all reported adverse events) when used in a real-life setting, and to monitor and document the drug utilization patterns of Wakix® in routine medical practice. The other objectives are to assess the clinical benefit of a treatment with pitolisant (Wakix®) in a real-life setting on excessive diurne somnolence and other symptoms of narcolespy, and the health care resource use (hospitalizations, emergency visits, unscheduled visits) due to narcolepsy, to measure the treatment compliance, the quality of life and disease burden. Patients will be recruited in the 4 countries where Wakix will be first launched (i.e. France, UK, Italy, Germany), by around 8 to 10 sites in each.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)EMA/H/C/002616
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsKappa Santé
Department/Research groupKappa Santé
Organisation/affiliationKappa Santé
Website/Homepagewww.kappasante.com
Details of (Primary) lead investigator
Title Dr
Last name SCHÜCK
First name Stéphane
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Germany
Italy
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed16/06/201621/07/2016
Start date of data collection03/10/201615/12/2016
Start date of data analysis30/11/2024
Date of interim report, if expected
Date of final study report30/03/2025
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesbioprojet100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lecomte
First name Isabelle
Address line 1Bioprojet
Address line 29 rue Rameau 
Address line 3 
CityParis 
Postcode75003 
CountryFrance
Phone number (incl. country code)33147036616 
Alternative phone number 
Fax number (incl. country code) 
Email address i.lecomte@bioprojet.com
Public Enquiries
Title Dr 
Last name SCHÜCK 
First name Stéphane 
Address line 14 rue de Cléry 
Address line 2 
Address line 3 
CityParis 
Postcode75002 
CountryFrance 
Phone number (incl. country code)0033144827474 
Alternative phone number 
Fax number (incl. country code) 
Email address stephane.schuck@kappasante.com 
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