Overview

The Nuvigil and Provigil Pregnancy Registry

Status:
Recruiting
Trial end date:
2027-01-31
Target enrollment:
0
Participant gender:
Female
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.
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries, Ltd.
Collaborator:
United BioSource Corporation
Treatments:
Armodafinil
Modafinil
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.