Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Recruiting

• Conditions: Migraine
• Interventions: Drug: Various; Other: No intervention; Drug: Rimegepant

• Registration Number: NCT05198245
• Lead Sponsor: Pfizer

Brief Summary

The purpose of the study is to evaluate the risk of pregnancy and infant outcomes among women with migraine exposed to rimegepant during pregnancy and in two rimegepant unexposed comparator groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2028-04-17
• Study Completion: 2028-04-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnancies in women with migraine exposed to other medications	Various	Pregnancies in women with migraine exposed to other medications indicated for the treatment of migraine
Pregnancies in women without migraine	No intervention	-
Pregnancies in women with migraine and exposure to rimegepant	Rimegepant	-

Primary Outcome Measures

Name	Time	Method
Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births	Annually beginning April 2022

Secondary Outcome Measures

Name	Time	Method
Elective terminations	Annually beginning April 2022
Preterm births	Annually beginning April 2022
Pre-eclampsia/eclampsia	Annually beginning April 2022

Trial Locations

Locations (1)

Research Triangle Institute d/b/a RTI Health Solutions; 🇺🇸 Research Triangle Park, North Carolina, United States