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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  AIMOVIG
• Study drug International non-proprietary name (INN) or common name:
  ERENUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CD01) erenumab

  erenumab
• Medical condition to be studied:
  Migraine

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1300

Study design details

• Study design:
  This is an observational prospective cohort study of patients with migraine treated with erenumab in a real-world setting.
• Main study objective:
  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.
• Outcomes:
  • Patient incidence of adverse drug reaction ; • Patient incidence of adverse event ; • Patient incidence of adverse drug reaction regarding safety specifications ; • Patient incidence of adverse drug by patient background and characteristics (such as sex, age, disease duration, medical history) ; • Patient incidence of adverse drug by time of onset
• Data analysis plan:
  For safety analysis, the number of patients with adverse drug reactions and serious adverse drug reactions during the observation period and the incidence in all patients will be tabulated. The same analyses will be performed for adverse events, serious adverse events, etc.