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| ID | Type | Description | Link |
|---|---|---|---|
| C4951005 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| PPD, Part of Thermo Fisher Scientific | INDUSTRY |
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The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women with migraine exposed to Rimegepant | Pregnant women with a diagnosis of migraine who are exposed to rimegepant at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception) |
| |
| Pregnant women with migraine not exposed to Rimegepant | Pregnant women with a diagnosis of migraine who are not exposed to rimegepant (up to 5 product half-lives prior to conception) but who may be exposed to other products for the treatment/prevention of migraine at any time during pregnancy or just prior to pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Other | 75mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Major congenital malformation (birth defect) | Healthcare provider report through the registry | Annually beginning April 2022 |
| Measure | Description | Time Frame |
|---|---|---|
| Minor congenital malformation | Healthcare provider report through the registry | Annually beginning April 2022 |
| Gestational hypertension | Healthcare provider report through the registry |
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Inclusion Criteria:
Exclusion Criteria:
• Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy
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The study population will include pregnant women of any age within the US with migraine who were treated with rimegepant as part of routine care at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception), as well as pregnant women with migraine not exposed to rimegepant before or during pregnancy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidera, a PPD business unit | Recruiting | Wilmington | North Carolina | 28401 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
| Nurtec Pregnancy Registry | 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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| Not taking Rimegepant |
| Other |
No rimegepant |
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| Annually beginning April 2022 |
| Pre-eclampsia | Healthcare provider report through the registry | Annually beginning April 2022 |
| Eclampsia | Healthcare provider report through the registry | Annually beginning April 2022 |
| Gestational diabetes | Healthcare provider report through the registry | Annually beginning April 2022 |
| Spontaneous abortion | Healthcare provider report through the registry | Annually beginning April 2022 |
| Stillbirth | Healthcare provider report through the registry | Annually beginning April 2022 |
| Elective termination | Healthcare provider report through the registry | Annually beginning April 2022 |
| Preterm birth | Healthcare provider report through the registry | Annually beginning April 2022 |
| Small for gestational age | Healthcare provider report through the registry | Annually beginning April 2022 |
| Postnatal growth deficiency | Healthcare provider report through the registry | Annually beginning April 2022 |
| Infant developmental delay | Healthcare provider report through the registry | Annually beginning April 2022 |
| D009422 | Nervous System Diseases |