A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45357
• EU PAS number:
  EUPAS45356
• Study ID:
  45357
• Official title and acronym:
  A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This observational exposure registry will compare the occurrence of major congenital malformations in the fetuses/infants of women with migraine exposed to rimegepant during pregnancy or just prior to pregnancy to those not exposure to rimegepant during or just prior to pregnancy.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Pharmaceutical Product Development (PPD)

Study timelines

Date when funding contract was signed

Planned: 09/11/2020

Actual: 09/11/2020

Study start date

Planned: 01/07/2021

Actual: 23/09/2021

Data analysis start date

Planned: 01/04/2034

Date of interim report, if expected

Planned: 15/04/2022

Date of final study report

Planned: 01/04/2035

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

PFIZER 100%

Study protocol

Initial protocol

C4951005_BHV3000-402_BC102842-01_Protocol_25Apr2023_clean_signed

Updated protocol

C4951005_MONITOR PROTOCOL CLEAN_V3.0_25APR2023.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)