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.