Observational Cohort Study of Exposure to Galcanezumab during Pregnancy (I5Q-MC-B003)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  GALCANEZUMAB
• Medical condition to be studied:
  Migraine

  Cluster headache

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  To monitor exposure to galcanezumab during pregnancy among women with migraine or cluster headache and study the incidence of pregnancy outcomes in women with migraine exposed to galcanezumab.
• Outcomes:
  Maternal, foetal, and/or infant outcomes
• Data analysis plan:
  The incidence of pregnancy outcomes (maternal, foetal, and/or infant outcomes) in pregnancies of galcanezumab-exposed migraine patients will be compared to other women with migraine unexposed to prophylactic migraine medication and women with migraine treated with other prophylactic migraine medication.