Study identification

PURI

https://redirect.ema.europa.eu/resource/47509

EU PAS number

EUPAS39745

Study ID

47509

Official title and acronym

A post-authorisation safety study (PASS) to evaluate the long-term cardiovascular and psychiatric safety profile of methylphenidate (MPH) in adult patients with attention deficit/hyperactivity disorder (ADHD) in European Countries (PASS on methylphenidate in adults)

DARWIN EU® study

No

Study countries

Denmark
Norway
Sweden

Study description

There is limited and inconsistent data from pharmacoepidemiologic studies on MPH use and adverse cardiovascular or psychiatric events, especially among adults. The overall aim of the PASS is to compare the risk of first-time cardiovascular or psychiatric events in association with new use of MPH monotherapy versus new use of non-MPH ADHD medications (lisdexamfetamine, dexamfetamine and atomoxetine, monotherapy) and versus no use of ADHD medication in adult patients aged ≥18 years newly diagnosed with ADHD, in healthcare databases of three European countries

Study status

Planned
Research institution and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution
Non-Pharmaceutical companyENCePP partner

Contact details

Ana Luiza Bierrenbach

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Medice
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

EMEA/H/N/PSP/S/0064