The Nuvigil and Provigil Pregnancy Registry



Status:Recruiting
Conditions:Insomnia Sleep Studies, Psychiatric, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:8/9/2018
Start Date:June 30, 2009
End Date:January 30, 2027
Contact:Registry Call Center
Phone:866-404-4106

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Trial Summary
Trial Overview
Inclusion Criteria

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 Criteria:

- Reported exposure to Nuvigil (armodafinil) and/or brand or generic formulations of
Provigil (modafinil) within 6 weeks of becoming pregnant, or during pregnancy

- Able and willing to provide informed consent

- 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 brand or generic formulation of modafinil

- Pregnancy from outside the United States
We found this trial at
1
site
Teva Pregnancy Registry
Horsham, Pennsylvania
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mi
from
Horsham, PA
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