Status: Planned First registered on: 29/10/2018
Last updated on: 28/01/2020
1. Study identification
EU PAS Register NumberEUPAS26319
Official titleDomperidone Use and Misuse in Parkinson Disease
Study title acronymDUMP
Study typeObservational study
Brief description of the studyParkinson 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicablehttp://recap-inserm.fr/dump-fr.html
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacoepidemiology INSERM 1027
Department/Research groupPharmacoepidemiology research team
Organisation/affiliationUniversity of Toulouse 3 and INSERM 1027
Website/Homepagehttp://www.u1027.inserm.fr/
Details of (Primary) lead investigator
Title Dr
Last name Lapeyre-Mestre
First name Maryse
Is this study being carried out with the collaboration of a research network?
Yes
RECAP
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

Paris Pharmacoepidemiology Centre
Pharmacoepidemiology INSERM 1027
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/01/201702/01/2017
Start date of data collection01/01/2018
Start date of data analysis04/06/2018
Date of interim report, if expected
Date of final study report06/01/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherAppel d'offres ANSM 2016100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lapeyre-Mestre
First name Maryse
Address line 137 Allees Jules
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance
Phone number (incl. country code)33-561145960 
Alternative phone number33-561145606 
Fax number (incl. country code)33-561145928 
Email address maryse.lapeyre-mestre@univ-tlse3.fr
Public Enquiries
Title Dr 
Last name Lapeyre-Mestre 
First name Maryse 
Address line 137 Allees Jules 
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance 
Phone number (incl. country code)33-561145960 
Alternative phone number33-561145606 
Fax number (incl. country code)33-561145928 
Email address maryse.lapeyre-mestre@univ-tlse3.fr 
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