Prospective pregnancy study to assess maternal and fetal outcomes following exposure to galcanezumab (I5Q-MC-B005)

Study type

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Pregnancy registry

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:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1260

Study design details

• Main study objective:
  To evaluate maternal and fetal outcomes associated with exposure to galcanezumab
• Outcomes:
  -Major malformations up to 1-year after birth (adjudication needed)-Minor malformations up to 1 year after birth-Pre-eclampsia and hypertension during pregnancy-Spontaneous abortions-Stillbirths-Elective terminations-Preterm births -Small-for-gestational-age births-Postnatal growth and development (not defined by the agency, welcome your suggestions) through the first year of life
• Data analysis plan:
  TBD