Status:
TERMINATED
The Nuvigil and Provigil Pregnancy Registry
Lead Sponsor:
Cephalon, Inc.
Conditions:
Narcolepsy
Obstructive Sleep Apnea
Eligibility:
FEMALE
Brief Summary
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.
Detailed Description
Both the prospective and the retrospective data are captured.
Eligibility Criteria
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 who refuse to provide oral or written informed consent.
- 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.
Key Trial Info
Start Date :
June 30 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT01792583
Start Date
June 30 2009
End Date
November 30 2023
Last Update
February 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Teva Pregnancy Registry
West Chester, Pennsylvania, United States, 19380