A 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 (WAKIX PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40614
• EU PAS number:
  EUPAS13818
• Study ID:
  40614
• Official title and acronym:
  A 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 (WAKIX PASS)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  United Kingdom
• Study description:
  International, 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 5 countries where Wakix will be first launched (i.e. France, UK, Italy, Germany, Belgium), by around 8 to 10 sites in each.
• Study status:
  Ongoing

Research institution and networks

Institutions

Kappa Santé

France

Study timelines

Date when funding contract was signed

Planned: 16/06/2016

Actual: 21/07/2016

Study start date

Planned: 03/10/2016

Actual: 15/12/2016

Data analysis start date

Planned: 30/11/2024

Date of final study report

Planned: 30/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

bioprojet

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  EMA/H/C/002616