Study identification

PURI

https://redirect.ema.europa.eu/resource/33284

EU PAS number

EUPAS26319

Study ID

33284

Official title and acronym

Domperidone Use and Misuse in Parkinson Disease (DUMP)

DARWIN EU® study

No

Study countries

France

Study description

Parkinson disease (PD) is the second neurodegenerative disease affecting 1% of the population over 60 years (160000 patients in France), with treatment based on dopamine replacement therapies. Nausea is the most frequent adverse event, occurring in 30-40% of patients at the treatment initiation whatever the drug. Because it does not cross the blood-brain barrier, domperidone, an antiemetic D2 receptor antagonist, is widely used in PD. Increasing risk of arrhythmia, sudden death and cardiac arrest reported with prolonged use and high doses, led the PRAC to recommend restricting domperidone use to patients younger than 60 years at doses below 30 mg/day and for 7 days maximum.The aim of this project is to conduct a pharmacoepidemiological study to determine the use and misuse of domperidone in PD in France based on complementary approaches: - A retrospective analysis of the French health insurance database (SNDS),- A cross sectional observational study performed in consecutive patients followed by the 24 PD expert centers of the NS Park network, general hospitals and private practice neurologists, - A qualitative approach to investigate the practices and beliefs of French neurologists regarding use and misuse of domperidone in PD.The first study will provide national patterns of domperidone dispensing to PD patients, the second will provide data on the actual use of domperidone by French neurologists and survey on regular practices of domperidone prescribing will provide information on the current opinions about the drug, the indications for which it is prescribed and how contra-indications are evaluated. This information will help Regulatory Authorities to communicate about the safety profile of the drug. Finally, our results obtained in the French population will be compared to those from the European Union countries using domperidone and from which data has been published.

Study status

Planned
Research institutions and networks

Institutions

University Toulouse III
France
First published:
01/02/2024
InstitutionEducational Institution
INSERM 1027

Networks

RECAP

Contact details

Maryse Lapeyre-Mestre

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Appel d'offres ANSM 2016
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable