Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

NCT05198245 | Active Not Recruiting

• 2 other identifiers: BHV3000-403C4951006
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine; Migraine Disorder; Migraine Prevention; Prevention of Migraine; Pregnant; Pregnancy; Infant

Outcome Measures

Primary Outcomes (1)

• Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births

  Annually beginning April 2022

Secondary Outcomes (3)

• Elective terminations

  Annually beginning April 2022

• Preterm births

  Annually beginning April 2022

• Pre-eclampsia/eclampsia

  Annually beginning April 2022

Study Arms (3)

Pregnancies in women with migraine and exposure to rimegepant

Drug: Rimegepant

Pregnancies in women with migraine exposed to other medications

Pregnancies in women with migraine exposed to other medications indicated for the treatment of migraine

Drug: Various

Pregnancies in women without migraine

Other: No intervention

Interventions

Rimegepant DRUG

Rimegepant 75mg

Pregnancies in women with migraine and exposure to rimegepant

Various DRUG

Various

Pregnancies in women with migraine exposed to other medications

No intervention OTHER

No intervention

Pregnancies in women without migraine

Eligibility Criteria

• Age: 16 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of pregnant women (any age) as well as the infants (male and female) born to enrolled participants through age 1 year

You may qualify if:

• All pregnant women aged 16 to 49 years, inclusive, at the estimated LMP within the study observation period are eligible to enter in the study.

You may not qualify if:

• Has insufficient information to estimate LMP
• Has at least 1 pharmacy dispensing for ditans (i.e., lasmiditan) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period
• Has at least 1 pharmacy dispensing for a CGRP receptor antagonist other than rimegepant (i.e., ubrogepant, atogepant, and zavegepant) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period
• Has at least 1 pharmacy dispensing for CGRP monoclonal antibodies (i.e., erenumab, fremanezumab, eptinezumab, and galcanezumab) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period
• Additional Eligibility Criteria (Rimegepant-Exposed Group):
• Have a migraine diagnosis any time before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
• Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
• Have a recorded outcome of pregnancy within the study period
• Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days
• Have a migraine diagnosis any time before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
• Have at least 1 pharmacy dispensing for a medication indicated for the treatment of migraine within the 30-day time window before the estimated LMP and ending with whichever is first: end of pregnancy or end of the study period.
• Have a recorded outcome of pregnancy within the study period
• Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days
• Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
• Have no migraine diagnosis any time before the estimated LMP through whichever is first: end of pregnancy or end of the study period

Sponsors & Collaborators

• Pfizer: lead
• RTI Health Solutions: collaborator
• Optum, Inc.: collaborator

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 20, 2022
• Study Start: December 15, 2021
• Primary Completion (Estimated): April 17, 2028
• Study Completion (Estimated): April 17, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)