Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Reyvow
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