Post-authorisation safety study to evaluate the utilisation and safety of atogepant in patients with migraine and significant cardiovascular or cerebrovascular disease in Europe

Study identification

• EU PAS number:
  EUPAS1000000648
• Study ID:
  1000000648
• Official title and acronym:
  Post-authorisation safety study to evaluate the utilisation and safety of atogepant in patients with migraine and significant cardiovascular or cerebrovascular disease in Europe
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Netherlands

  Spain

  Sweden
• Study description:
  No information provided.
• Study status:
  Ongoing

Research institutions and networks

Institutions

AbbVie

Study timelines

Date when funding contract was signed

Planned:28/11/2023

Actual:18/12/2024

Study start date

Planned:30/06/2025

Actual:05/01/2026

Date of final study report

Planned:31/12/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie Inc.

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

P24-433