The Nuvigil and Provigil Pregnancy Registry

Overview

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.

Full Title of Study: “The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: January 31, 2027

Detailed Description

Both prospective and retrospective data are captured.

Interventions

  • Drug: Modafinil/armodafinil

Arms, Groups and Cohorts

  • 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).
  • Retrospective Cohort
    • Retrospective is define 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 test.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Incidence of minor birth defects
    • Time Frame: End of pregnancy through the first year after delivery
  • Incidence of adverse fetal outcomes other than birth defects
    • Time Frame: End of pregnancy through the first year after delivery
  • Incidence of major or minor birth defects using initial reporter terms
    • Time Frame: End of pregnancy through the first year after delivery
    • Initial reporter (e.g., patient or healthcare professional)
  • Incidence of adverse pregnancy outcome attributed to Provigil (modafinil) or Nuvigil (armodafinil)
    • Time Frame: Baseline and End of pregnancy
  • Incidence of elective termination due to identified anomaly/birth defect or increased risk of anomaly/birth defect
    • Time Frame: Baseline and End of pregnancy
  • Incidence of spontaneous abortion (defined as <20 weeks gestation)
    • Time Frame: Baseline and End of pregnancy
  • Incidence of fetal death (defined as >=20 weeks gestation
    • Time Frame: Baseline and End of pregnancy
  • Incidence of neurodevelopmental problems
    • Time Frame: Baseline and End of pregnancy
  • Incidence of other complications of pregnancy including preterm delivery, preeclampsia/pregnancy-induced hypertension and low/very low birth weight (LBW/VLBW)
    • Time Frame: Baseline and End of pregnancy

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Teva Pharmaceutical Industries, Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Registry Call Center, 866-404-4106, USMedInfo@tevapharm.com

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