Retrospective Cohort Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45953
• EU PAS number:
  EUPAS45952
• Study ID:
  45953
• Official title and acronym:
  Retrospective Cohort Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  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, one of pregnant women with migraine treated with other medications indicated for the acute treatment or prevention of migraine during pregnancy, and a group of pregnant women without migraine. This is an observational, retrospective, cohort study using prospectively collected secondary health care data from a single US data source.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Optum- United States

Study timelines

Date when funding contract was signed

Planned: 18/06/2020

Actual: 18/06/2020

Study start date

Planned: 15/07/2021

Actual: 11/08/2021

Data analysis start date

Planned: 01/04/2028

Date of interim report, if expected

Planned: 30/04/2022

Actual: 29/04/2022

Date of final study report

Planned: 30/04/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer (100%)

Study protocol

Initial protocol

C4951006_PROTOCOL_V1.0_08DEC2021.pdf

Updated protocol

C4951006_PROTOCOL_V5.0_21AUG2023.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)

Other study registration identification numbers and links

NCT05198245

Link to Clinicaltrials.gov