Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198245
• Other study ID #: BHV3000-403
• Secondary ID: C4951006
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: April 17, 2028

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: Pfizer Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8082
• Est. completion date: April 17, 2028
• Est. primary completion date: April 17, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Rimegepant
Rimegepant 75mg
• Various
Various

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	Research Triangle Institute d/b/a RTI Health Solutions	Research Triangle Park	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Pfizer	Optum, Inc., RTI Health Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births		Annually beginning April 2022
Secondary	Elective terminations		Annually beginning April 2022
Secondary	Preterm births		Annually beginning April 2022
Secondary	Pre-eclampsia/eclampsia		Annually beginning April 2022

External Links

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