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Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant (MONITOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05046613
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : November 15, 2021
Sponsor:
Collaborator:
Biohaven Pharmaceutical Holding Company Ltd.
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.

Condition or disease Intervention/treatment
Migraine Other: Rimegepant Other: Not taking Rimegepant

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Study Type : Observational
Estimated Enrollment : 780 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Registry Based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)
Actual Study Start Date : November 4, 2021
Estimated Primary Completion Date : April 30, 2034
Estimated Study Completion Date : April 30, 2034

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Group/Cohort Intervention/treatment
Pregnant women with migraine exposed to Rimegepant Other: Rimegepant
75mg

Pregnant women with migraine not exposed to Rimegepant Other: Not taking Rimegepant
No rimegepant




Primary Outcome Measures :
  1. Major congenital malformation (birth defect) [ Time Frame: Annually beginning April 2022 ]
    Healthcare provider report through the registry



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05046613


Contacts
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Contact: Elyse Stock, MD 203-404-0410 Clinicaltrials@biohavenpharma.com

Locations
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United States, North Carolina
PPD Recruiting
Morrisville, North Carolina, United States, 27560
Contact: Kristin Veley, PharmD, MPH    877-366-0324    nurtecpregnancyregistry@ppd.com   
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
Biohaven Pharmaceutical Holding Company Ltd.
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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05046613    
Other Study ID Numbers: BHV3000-402
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biohaven Pharmaceuticals, Inc.:
Migraine, Migraine Headache, Migraine Disorder, Migraine Prevention, Prevention of Migraine, Pregnant, Pregnancy, Infant
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases