Status: Planned First registered on: 29/07/2020
Last updated on: 22/05/2023
1. Study identification
EU PAS Register NumberEUPAS36014
Official titleA non-interventional study to examine patient characteristics and drug utilization patterns in migraine patients treated with prophylactic drugs in Nordic countries
Study title acronym
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableCAMG334A2023
2. Research centres and Investigator details
Coordinating study entity
Centre nameNovartis Pharmaceuticals
Centre locationBasel, Switzerland
Details of (Primary) lead investigator
Title Professor
Last name Sørensen
First name Henrik Toft
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

Centre for Pharmacoepidemiology (CPE)
IQVIA
Aarhus University Dept. of Clinical Epidemiology
University of Bergen, Kalfarveien 31, 5018 Bergen, Norway
Countries in which this study is being conducted
International study

Denmark
Finland
Norway
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/11/201806/11/2018
Start date of data collection28/08/2024
Start date of data analysis
Date of interim report, if expected20/12/2022
Date of final study report28/08/2025
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNovartis Pharma AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Ehrenstein
First name Vera
Address line 1Olof Palmes Allé 43-45
Address line 2 
Address line 3 
CityAarhus N 
Postcode8200 
CountryDenmark
Phone number (incl. country code)45-87168063 
Alternative phone number 
Fax number (incl. country code) 
Email address ve@clin.au.dk
Public Enquiries
Title Ms 
Last name Clinical Disclosure Officer 
First name Novartis 
Address line 1Novartis Pharma AG 
Address line 2 
Address line 3 
CityBasel 
PostcodeCH-4002 
CountrySwitzerland 
Phone number (incl. country code)41613241111 
Alternative phone number 
Fax number (incl. country code) 
Email address Trialandresults.registries@novartis.com 
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