Inpatient Constipation Among Migraine Patients Treated With Preventive Medications: A Retrospective Cohort Study in a United States Electronic Health Record Database

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44534
• EU PAS number:
  EUPAS37877
• Study ID:
  44534
• Official title and acronym:
  Inpatient Constipation Among Migraine Patients Treated With Preventive Medications: A Retrospective Cohort Study in a United States Electronic Health Record Database
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective, observational cohort study of migraine patients identified from Optum’s Electronic Health Record (EHR) Research Database from 17 May 2018 through 31 March 2020. Patients over the age of 18, with a clinical diagnosis of migraine, who are treated with erenumab (Aimovig®), other calcitonin-gene related peptide (CGRP) antagonists, or standard of care (SOC) antiepileptic preventive medications, are eligible for this study. The study will describe baseline characteristics, and estimate the incidence proportion of inpatient constipation. The study will also assess the comparability of migraine patients treated with erenumab to migraine patients treated with other CGRP antagonists, and, separately, with SOC antiepileptic preventive medications, with respect to baseline patient characteristics. Finally, if the cohorts are comparable, this study will compare the incidence proportion of inpatient constipation among migraine patients treated with erenumab to migraine patients treated with other CGRP antagonists, and, separately, to migraine patients treated with SOC migraine preventive antiepileptic medications.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 06/12/2019

Actual: 06/12/2019

Study start date

Planned: 11/11/2020

Actual: 18/11/2020

Data analysis start date

Planned: 01/01/2021

Actual: 04/12/2020

Date of final study report

Planned: 01/12/2021

Actual: 01/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

EUPAS37877-38072

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable