Observational cohort study of exposure to lasmiditan during pregnancy (H8H-MC-B002)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Reyvow
• Study drug International non-proprietary name (INN) or common name:
  LASMIDITAN
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CC08) lasmiditan

  lasmiditan
• Medical condition to be studied:
  Migraine

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • 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)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  683

Study design details

• Main study objective:
  To estimate and compare the prevalence of composite major congenital malformation in infants of women with a dispensing of lasmiditan 30 days prior to last menstrual period and anytime during the first trimester of pregnancy compared to three unexposed comparator groups.
• Outcomes:
  major congenital malformation, spontaneous abortion, stillbirth, preterm birth, small for gestational age, gestational hypertension, pre-eclampsia, eclampsia.
• Data analysis plan:
  Comparative analysis