Clinical trial NCT05198245: Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Official title: Retrospective Cohort Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: Migraine
Migraine Disorder
Migraine Prevention
Prevention of Migraine
Pregnant
Pregnancy
Infant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: RTI Health Solutions
name: Optum, Inc.
First posted: 2022-01-20
Enrollment: 1
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


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

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

Primary outcomes:
measure: Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births
timeFrame: Annually beginning April 2022
Secondary outcomes:
measure: Elective terminations
timeFrame: Annually beginning April 2022
measure: Preterm births
timeFrame: Annually beginning April 2022
measure: Pre-eclampsia/eclampsia
timeFrame: Annually beginning April 2022
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: Research Triangle Institute d/b/a RTI Health Solutions
state: North Carolina
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: