Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Retrospective Cohort Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Other: No intervention; Drug: Rimegepant; Drug: Various

• Study Type: Observational
• Enrollment (Estimated): 8082

Contacts and Locations

• Study Contact: Name: Pfizer Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27709
      • Recruiting
      • Research Triangle Institute d/b/a RTI Health Solutions
      • Contact: Study Contact; Phone Number: 800-262-3011

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria (All Pregnancies):

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.

Exclusion Criteria (All Pregnancies):

• 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

Additional Inclusion Criteria (Primary Comparator 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 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

Additional Exclusion Criteria (Primary Comparator Group):

• 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

Additional Inclusion Criteria (Secondary Comparator Group):

• Have no migraine diagnosis any time before the estimated LMP 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

Additional Exclusion Criteria (Secondary Comparator Group):

• Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnancies in women with migraine and exposure to rimegepant	Drug: Rimegepant; Rimegepant 75mg
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; Various
Pregnancies in women without migraine	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Elective terminations	Annually beginning April 2022
Preterm births	Annually beginning April 2022
Pre-eclampsia/eclampsia	Annually beginning April 2022

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Optum, Inc.; RTI Health Solutions
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): April 17, 2028
• Study Completion (Estimated): April 17, 2028

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Migraine; Infant; Migraine Prevention; Pregnant; Migraine Disorder; Prevention of Migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: BHV3000-403; C4951006 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No