Study identification

PURI

https://redirect.ema.europa.eu/resource/40208

EU PAS number

EUPAS34832

Study ID

40208

Official title and acronym

Estimating Event Rates Using the Medication Cohort Module: Hypertension and Negative Control Outcomes in New Users of Onabotulinumtoxin A and Monoclonal Antibodies Targeting the Calcitonin-Gene-Related Pathway in the Marketscan EarlyView Claims Database (20200218)

DARWIN EU® study

No

Study countries

United States

Study description

This retrospective observational study will estimate event rates in migraine patients in four medication cohorts in an administrative claims database: new users of erenumab-aooe, new users of fremanezumab-vfrm, new users of galcanezumab-gnlm, and new users of onabotulinumtoxin A. The outcomes of interest include any hypertension, serious hypertension, hypertensive crisis, road traffic accidents, falls, and influenza vaccination.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol
English (628.94 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable