Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Recruiting · NCT05046613 · Observational (researchers observe without assigning treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
Not taking RimegepantRimegepant
What this trial is about
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
Who can take part
Age range
0 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception)
- Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy
Exclusion criteria
- Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy
Where it is running
1 location listed across 1 US state.
- Evidera, a PPD business unit - Wilmington, North Carolina, United States