NCT05046613 Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
| NCT ID | NCT05046613 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pfizer |
| Condition | Migraine |
| Study Type | OBSERVATIONAL |
| Enrollment | 780 participants |
| Start Date | 2021-09-23 |
| Primary Completion | 2029-11-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 780 participants in total. It began in 2021-09-23 with a primary completion date of 2029-11-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
Eligibility Criteria
Inclusion Criteria: * Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception) * Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy 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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT05046613 clinical trial?
This trial is open to female participants only, aged 0 Years or older, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05046613 currently recruiting?
Yes, NCT05046613 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT05046613 trial being conducted?
This trial is being conducted at Wilmington, United States.
Who is sponsoring the NCT05046613 clinical trial?
NCT05046613 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 780 participants.
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