The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry
Overview
- Phase
- Not Applicable
- Intervention
- Modafinil/armodafinil
- Conditions
- Narcolepsy
- Sponsor
- Cephalon, Inc.
- Enrollment
- 191
- Locations
- 1
- Primary Endpoint
- Incidence of major birth defects
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Prospective Cohort
Prospective is defined per protocol: prospective data of pregnancy exposure are data acquired prior to the knowledge of the pregnancy outcome or prior to the detection of a congenital malformation at prenatal examination (e.g. fetal ultrasound, serum markers).
Intervention: Modafinil/armodafinil
Retrospective Cohort
Retrospective is defined per protocol: retrospective data of pregnancy exposure are data acquired after the outcome of the pregnancy is known or after the detection of a congenital malformation on prenatal examination.
Intervention: Modafinil/armodafinil
Outcomes
Primary Outcomes
Incidence of major birth defects
Time Frame: End of pregnancy through the first year after delivery
Major birth defects using Metropolitan Atlanta Congenital Birth Defects Program (MACDP) definitions
Secondary Outcomes
- Incidence of minor birth defects(End of pregnancy through the first year after delivery)
- Incidence of Microcephaly(End of pregnancy)
- Incidence of small size for gestational age(End of pregnancy)
- Incidence of intrauterine growth restriction (IUGR)(End of pregnancy)
- Incidence of Low/very low birth weight (LBW/VLBW)(End of pregnancy)
- Incidence of Preterm delivery(End of pregnancy)
- Incidence of Preeclampsia/pregnancy-induced hypertension (PIH)(Baseline through End of pregnancy)
- Maternal breastmilk feeding practices(End of pregnancy through the first year after delivery)
- Incidence of elective termination due to identified anomaly/birth defect or increased risk of anomaly/birth defect(Baseline and End of pregnancy)
- Incidence of spontaneous abortion (defined as <20 weeks gestation)(Baseline and End of pregnancy)
- Incidence of fetal death (defined as >=20 weeks gestation(Baseline and End of pregnancy)
- Incidence of neurodevelopmental problems(Baseline and End of pregnancy)