Specific Drug Use-results Surveillance (Long-term) for Erenumab in Migraine Patients in Japan (20210048)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45964
• EU PAS number:
  EUPAS45236
• Study ID:
  45964
• Official title and acronym:
  Specific Drug Use-results Surveillance (Long-term) for Erenumab in Migraine Patients in Japan (20210048)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  To describe the occurrence of hypertension and cardiovascular events in patients treated with erenumab and to describe the safety and efficacy of long-term treatment with erenumab under real-world conditions.
• Study status:
  Planned

Research institutions and networks

Institutions

Amgen

United States

Chiba University Hospital Chiba, Japan

Study timelines

Date when funding contract was signed

Planned: 12/02/2022

Study start date

Planned: 20/02/2022

Data analysis start date

Planned: 30/08/2028

Date of final study report

Planned: 30/08/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original erenumab 20210048 .pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only