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| ID | Type | Description | Link |
|---|---|---|---|
| C4951006 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| RTI Health Solutions | OTHER |
| Optum, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnancies in women with migraine and exposure to 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 |
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| Pregnancies in women without migraine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | Rimegepant 75mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births | Annually beginning April 2022 |
| Measure | Description | Time Frame |
|---|---|---|
| Elective terminations | Annually beginning April 2022 | |
| Preterm births | Annually beginning April 2022 | |
| Pre-eclampsia/eclampsia |
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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):
Additional Eligibility Criteria (Rimegepant-Exposed Group):
Additional Inclusion Criteria (Primary Comparator Group):
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):
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
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10001 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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| Various |
| Drug |
Various |
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| No intervention | Other | No intervention |
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| Annually beginning April 2022 |
| D009422 | Nervous System Diseases |