Assessment of Pregnancy Outcomes in Women Exposed to Modafinil/Armodafinil: Pregnancy Database Study

Study identification

• EU PAS number:
  EUPAS43538
• Study ID:
  45563
• Official title and acronym:
  Assessment of Pregnancy Outcomes in Women Exposed to Modafinil/Armodafinil: Pregnancy Database Study
• DARWIN EU® study:
  No
• Study countries:
  France

  United States
• Study status:
  Ongoing

Research institutions and networks

Institutions

IBM Watson

Study timelines

Date when funding contract was signed

Actual:16/07/2020

Study start date

Planned:31/12/2021

Actual:23/11/2021

Date of final study report

Planned:31/03/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva Branded Pharmaceutical Products R&D, 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)