Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
Pfizer
Study ID
NCT05046613
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
0 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.

Key Dates

Start date
Sep 23, 2021
Status verified
May 2026
Primary completion
Nov 4, 2029
Completion
Apr 30, 2034

Study Design

Enrollment
780 participants (estimated)

Arms

  • Arm: Pregnant women with migraine exposed to Rimegepant
    Pregnant women with a diagnosis of migraine who are exposed to rimegepant at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception)
  • Arm: Pregnant women with migraine not exposed to Rimegepant
    Pregnant women with a diagnosis of migraine who are not exposed to rimegepant (up to 5 product half-lives prior to conception) but who may be exposed to other products for the treatment/prevention of migraine at any time during pregnancy or just prior to pregnancy

Primary Outcome Measure

Major congenital malformation (birth defect) [ Time Frame: Annually beginning April 2022 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Evidera, a PPD business unitWilmingtonNorth Carolina28401-

Find similar trials in Wilmington, NC

By condition
Migraine
By specialty
Neurology
By research site
Evidera, a PPD business unit· Wilmington, NC

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