Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000240

EU PAS number

EUPAS1000000240

Study ID

1000000240

Official title and acronym

DARWIN EU® - CGRP antagonists - Treatment patterns and users characteristics

DARWIN EU® study

Yes

Study countries

Croatia
Finland
Germany
Spain

Study description

The aim of this study is to characterise individuals treated with CGRP antagonists for migraine.

The specific study objectives are:
1. Characterisation of patients newly treated with CGRP antagonists (i.e. new user cohort) in terms of demographics, risk factors for erectile dysfunction, insomnia and hypertension and concomitant medications taken at index date. This characterisation will be stratified by sex.
2. Characterisation of treatment with CGRP antagonists in a cohort of new users in terms of duration of treatment.
3. Incidence rate of erectile dysfunction, insomnia, and hypertension in a newly diagnosed migraine population (irrespective of treatment) stratified by age groups and sex.
4. Incidence rate of erectile dysfunction, insomnia, and hypertension in a newly diagnosed migraine population initiating treatment with CGRP antagonists or other prophylactic treatments (anti-epileptics, TCA antidepressants, Beta-blockers, tricyclic antidepressants, calcium channel blockers), stratified by age groups and sex.
5. Incidence rate of erectile dysfunction, insomnia, and hypertension in the general population (as reference) stratified by age groups and sex.

Study status

Finalised
Research institution and networks

Institutions

Networks

Contact details

Julieta Politi

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_D2.2.3_Protocol_P3-C1-009_CGRP antagonists_V3.1.pdf

English (902.68 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable