Risk factors and incidence of inpatient constipation and inpatient constipation with serious complications among migraine patients treated with erenumab: A retrospective cohort study in a US Electronic Health Record Database (20200087)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40638
• EU PAS number:
  EUPAS34220
• Study ID:
  40638
• Official title and acronym:
  Risk factors and incidence of inpatient constipation and inpatient constipation with serious complications among migraine patients treated with erenumab: A retrospective cohort study in a US Electronic Health Record Database (20200087)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This retrospective observational study will describe the incidence and risk factors for inpatient constipation and inpatient constipation with serious complications among migraine patients treated with erenumab to give context to events observed in the clinical trials as well as real-world observations from post-marketing surveillance data.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Opum, Inc Eden Praire, Minnesota

Study timelines

Date when funding contract was signed

Planned: 06/12/2019

Actual: 06/12/2019

Study start date

Planned: 01/04/2020

Actual: 01/04/2020

Data analysis start date

Planned: 02/04/2020

Actual: 01/05/2020

Date of final study report

Planned: 01/05/2021

Actual: 20/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

01.02.06 Public Redacted Protocol Ver 1.0 2020-03-15 English

Regulatory

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