Clinical trial
The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry
Name
C10953/9022
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.
Trial arms
Trial start
2009-06-30
Estimated PCD
2023-11-30
Trial end
2023-11-30
Status
Terminated
Treatment
Modafinil/armodafinil
Arms:
Prospective Cohort, Retrospective Cohort
Other names:
Provigil, Nuvigil
Size
191
Primary endpoint
Incidence of major birth defects
End of pregnancy through the first year after delivery
Eligibility 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '21 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 191, 'type': 'ACTUAL'}}
Updated at
2024-02-05
1 organization
1 product
3 indications
Organization
CephalonProduct
Modafinil/armodafinilIndication
NarcolepsyIndication
Obstructive Sleep ApneaIndication
shift work sleep disorder