A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000327
• EU PAS number:
  EUPAS1000000327
• Study ID:
  1000000327
• Official title and acronym:
  A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The objective is to conduct a worldwide descriptive study to collect prospective and retrospective data in women exposed to omaveloxolone during pregnancy and/or lactation to assess risk associated with pregnancy, the maternal complications, and adverse effects on the developing fetus, neonate, and infant (through at least the first year of life) in the post-marketing setting.
• Study status:
  Planned

Research institutions and networks

Institutions

Biogen

Study timelines

Date when funding contract was signed

Actual: 17/05/2024

Study start date

Planned: 26/10/2026

Date of final study report

Planned: 30/04/2036

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen-100%

Study protocol

Initial protocol

296FA402 Protocol V1_Ready for HMA-EMA Upload_Redacted.pdf

Regulatory

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