Clinical trial NCT01792583: The Nuvigil and Provigil Pregnancy Registry
Official title: The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Narcolepsy
Obstructive Sleep Apnea
Shift Work Sleep Disorder
Keywords: pregnancy
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 191
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Registry is conducted in the US and includes female patients exposed to modafinil and/or armodafinil within 6 weeks prior to becoming pregnant or any time during pregnancy. The Registry is designed for open enrollment of all patients meeting the inclusion/exclusion criteria. Registry enrollment is initiated by either patients or healthcare professionals. Patients who meet the eligibility criteria and provide informed consent will be enrolled into the study.

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.

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.

Primary outcomes:
measure: Incidence of major birth defects
timeFrame: End of pregnancy through the first year after delivery
Secondary outcomes:
measure: Incidence of minor birth defects
timeFrame: End of pregnancy through the first year after delivery
measure: Incidence of elective termination due to identified anomaly/birth defect or increased risk of anomaly/birth defect
timeFrame: Baseline and End of pregnancy
measure: Incidence of spontaneous abortion (defined as <20 weeks gestation)
timeFrame: Baseline and End of pregnancy
measure: Incidence of fetal death (defined as >=20 weeks gestation
timeFrame: Baseline and End of pregnancy
measure: Incidence of neurodevelopmental problems
timeFrame: Baseline and End of pregnancy
measure: Incidence of Microcephaly
timeFrame: End of pregnancy
measure: Incidence of small size for gestational age
timeFrame: End of pregnancy
measure: Incidence of intrauterine growth restriction (IUGR)
timeFrame: End of pregnancy
measure: Incidence of Low/very low birth weight (LBW/VLBW)
timeFrame: End of pregnancy
measure: Incidence of Preterm delivery
timeFrame: End of pregnancy
measure: Incidence of Preeclampsia/pregnancy-induced hypertension (PIH)
timeFrame: Baseline through End of pregnancy
measure: Maternal breastmilk feeding practices
timeFrame: End of pregnancy through the first year after delivery
Other outcomes:
Locations:
city: West Chester
country: United States
facility: Teva Pregnancy Registry
state: Pennsylvania
Study officials:
References: