NCT05198245
Active, Not Recruiting
N/A
Retrospective Cohort Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
ConditionsMigraine
Overview
- Phase
- N/A
- Intervention
- Rimegepant
- Conditions
- Migraine
- Sponsor
- Pfizer
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births
- Status
- Active, Not Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Pregnancies in women with migraine and exposure to rimegepant
Intervention: 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
Intervention: Various
Pregnancies in women without migraine
Intervention: No intervention
Outcomes
Primary Outcomes
Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births
Time Frame: Annually beginning April 2022
Secondary Outcomes
- Elective terminations(Annually beginning April 2022)
- Preterm births(Annually beginning April 2022)
- Pre-eclampsia/eclampsia(Annually beginning April 2022)
Study Sites (1)
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