Study identification

PURI

https://redirect.ema.europa.eu/resource/50637

EU PAS number

EUPAS36014

Study ID

50637

Official title and acronym

A non-interventional study to examine patient characteristics and drug utilization patterns in migraine patients treated with prophylactic drugs in Nordic countries

DARWIN EU® study

No

Study countries

Denmark
Finland
Norway
Sweden

Study description

The primary objective is to describe utilization of erenumab among patients with migraine. The secondary objective is to identify potential comparators for a future erenumab PASS. The exploratory objectives are 1) to estimate rates of cardiovascular outcomes in patients initiating erenumab or other prophylactic migraine medication, and 2) to describe utilization of erenumab and outcome in pregnancy.

Study status

Planned
Research institution and networks

Institutions

University of Bergen Kalfarveien 31, 5018 Bergen, Norway

Contact details

Henrik Toft Sørensen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

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

Novartis Pharma AG
Study protocol
Initial protocol

CAMG334A2023-v02-Redacted-Protocol

English (1002.23 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)