A prospective, registry based, observational study to asses maternal, fetal and infant outcomes following exposure to lasmiditan (H8H-MC-B001)

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:
  RAYVOW
• 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)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • 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:
  840

Study design details

• Main study objective:
  The primary objective is to estimate the risk of major congenital malformations (composite) in infants of women exposed to lasmiditan during the first trimester of pregnancy compared to pregnant women with migraine unexposed to lasmiditan.
• Outcomes:
  Major congenital malformation, minor congenital malformation, maternal pregnancy complications, pregnancy/fetal outcomes, infant outcomes at birth, other adverse outcomes, including postnatal growth and development abnormalities.
• Data analysis plan:
  Estimate the risk of pregnancy outcomes among women exposed to lasmiditan during pregnancy compared to women unexposed to lasmiditan before or during pregnancy