Study identification

PURI

https://redirect.ema.europa.eu/resource/42426

EU PAS number

EUPAS34763

Study ID

42426

Official title and acronym

A Long-Term, Prospective, Observational Study to Evaluate the Safety, Including Cardiovascular Safety, of Fremanezumab in Patients with Migraine in Routine Clinical Practice Non-Interventional Phase 4 Study

DARWIN EU® study

No

Study countries

United States

Study description

The study will investigate the incidence of adverse events in a real world setting in migraine patients with long-term exposure to fremanezumab relative to migraine patients treated with other preventive migraine pharmacotherapy targeting the CGRP pathway or other preventive migraine pharmacotherapy not targeting the CGRP pathway. The objective of the study are to evaluate the long-term safety of fremanezumab in all patients with migraine through evaluation of incidence of all adverse events, and to evaluate the safety of fremanezumab in a sub population of CV compromised patients. The secondary objective is to examine the long-term safety of fremanezumab in patients with migraine by migraine treatment duration. This is a long-term, prospective, comparative, non-interventional, observational, controlled study. Patients aged 18 years or older with migraine who have been newly prescribed fremanezumab, non fremanezumab CGRP-pathway targeting preventive migraine medications or non-CGRP-pathway targeting preventive migraine medications will be identified and followed for a minimum of 3 years. Study variables include exposure to the study medications, incidence of adverse events, CV events and MACE (in CV-compromised patients), demographic data, baseline characteristics, medical history, prior use of medications for chronic medical conditions, concomitant medications used for at least 12 months prior to cohort entry, preventative migraine medications, pregnancy status, CV disease, hypertension, and other chronic medical conditions. Exposure to fremanezumab or other preventive migraine medications, medical history (including medicinal products prescribed), comorbidities, primary and secondary outcomes, potential confounding factors, and potential effect modifiers will be documented by the treating physicians.

Study status

Ongoing
Research institutions and networks

Institutions

Syneos Health
United Kingdom
First published:
06/03/2024
InstitutionNon-Pharmaceutical companyENCePP partner
Syneos Health
United Kingdom
First published:
06/03/2024
InstitutionNon-Pharmaceutical companyENCePP partner

Contact details

Natan Kahan

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Teva Branded Pharmaceutical Products R&D, Inc
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)