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
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)
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)
6. Study drug(s) information
Substance class (ATC Code)N02CD01 (erenumab)
Product NameAimovig
CountryFinland
Substance INN(s)ERENUMAB
Product NameAimovig
CountrySweden
Substance INN(s)ERENUMAB
Product NameAimovig
CountryNorway
Substance INN(s)ERENUMAB
Product NameAimovig
CountryDenmark
Substance INN(s)ERENUMAB
7. Medical conditions to be studied
Medical condition(s)Yes
Migraine
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Pregnant women
9. Number of subjects
Estimated total number of subjects10
Additional information
number of subjects not applicable
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
Danish Population registries, Denmark
Finnish Population registries, Finland
Norwegian Population registries, Norway
Swedish Population registries, Sweden
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
The primary objective of this study is to describe utilization of erenumab among patients with migraine
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
There is follow-up of maximum 4 years through registries - for exploratory objectives and eg. switch/discontinuation of erenumab
15. Data analysis plan
Please provide a brief summary of the analysis method
This will be a descriptive study. For the primary and secondary objectives, class descriptive characteristics will be summarized using frequencies and proportions. Continuous variables will be summarized using means with standard deviations and/or medians with interquartile ranges, and ranges, as appropiate. Continuous variables may be additionally categorized as appropiate clinically.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
