The Nuvigil and Provigil Pregnancy Registry
Reason given: The study is no longer feasible.
Key facts
- Where
- West Chester, United StatesSee the site
Where in United States
- Teva Pregnancy RegistryWest Chester, United StatesNo longer taking part
Trial details
- Who runs it
- Cephalon, Inc.
- Trial code
- NCT01792583
- Record updated
- 5 February 2024
- Original description
The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.Read full original descriptionShow less
The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry
The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.
Inclusion: Reported exposure to brand or generic formulations of Nuvigil (armodafinil) and/or Provigil (modafinil) within 6 weeks prior to becoming pregnant, or during pregnancy; Patients who provide oral or written informed consent; Infant up to 1 year of age born to a female with maternal exposure to armodafinil and/or modafinil within 6 weeks prior to becoming pregnant or during pregnancy; Able and willing to provide healthcare professional and secondary contact information, and for the patient herself to be contacted periodically by Registry staff.
Exclusion: Patients not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy; Infants whose mother was not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy; Patients who refuse to provide oral or written informed consent.