Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Sponsor

Biohaven Pharmaceuticals, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05198245

Collaborator

Biohaven Pharmaceutical Holding Company Ltd. (Industry)

4,020

Enrollment

Location

76.4

Anticipated Duration (Months)

52.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Rimegepant Drug: Various Other: No intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

4020 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 17, 2021

Anticipated Primary Completion Date :

Apr 30, 2028

Anticipated Study Completion Date :

Apr 30, 2028

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Pregnancy outcomes: Spontaneous abortion, fetal deaths/stillbirth. Fetal/Infant major congenital malformations, small for gestational age [Annually beginning April 2022]

Secondary Outcome Measures

Pregnancy outcomes: Elective termination, pre-eclampsia and/or eclampsia during pregnancy [Annually beginning April 2022]
Fetal/infant outcomes: preterm birth [Annually beginning April 2022]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

For Rimegepant exposed cohort:

Inclusion Criteria:

Migraine diagnosis any time prior to the estimated last menstrual period (LMP) or during pregnancy
At least one pharmacy dispensing for rimegepant within the defined pre-pregnancy time before the estimated LMP or any time during pregnancy

Exclusion Criteria:

Insufficient information to estimate the LMP
Certain migraine medications (e.g., Reyvow®, Ubrelvy®, Aimovig®, Ajovy®, Emgality®, Qulipta™, or Vyepti®) prior to or during pregnancy may be exclusionary

Rimegepant unexposed pregnant women with migraine cohort:

Inclusion Criteria:

Migraine diagnosis any time prior to the estimated LMP or during pregnancy
At least one pharmacy dispensing for a medication indicated for the treatment of migraine within the defined pre pregnancy time before the estimated LMP

Exclusion Criteria:

Certain migraine medications (e.g., Reyvow®, Ubrelvy®, Aimovig®, Ajovy®, Emgality®, Qulipta™, or Vyepti®) prior to or during pregnancy may be exclusionary

Rimegepant unexposed pregnant women without migraine cohort:

Inclusion Criteria:

Age 18 to 55 years, inclusive, at the estimated LMP

Exclusion Criteria:

Migraine diagnosis any time prior to the estimated LMP or during pregnancy
Certain migraine medications (e.g., Reyvow®, Ubrelvy®, Aimovig®, Ajovy®, Emgality®, Qulipta™, or Vyepti®) prior to or during pregnancy may be exclusionary