Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
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 |
---|---|---|
|
Study Design
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
|
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
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Research Triangle Institute d/b/a RTI Health Solutions | Research Triangle Park | North Carolina | United States | 27709 |
Sponsors and Collaborators
- Biohaven Pharmaceuticals, Inc.
- Biohaven Pharmaceutical Holding Company Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BHV3000-403