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The Nuvigil and Provigil Pregnancy Registry

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ClinicalTrials.gov Identifier: NCT01792583
Recruitment Status : Recruiting
First Posted : February 15, 2013
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc. ( Cephalon, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment
Narcolepsy Obstructive Sleep Apnea Shift Work Sleep Disorder Drug: Modafinil/armodafinil

Detailed Description:
Both the prospective and the retrospective data are captured.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 21 Months
Official Title: The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry
Actual Study Start Date : June 30, 2009
Estimated Primary Completion Date : January 31, 2027
Estimated Study Completion Date : January 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
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).
 Drug: Modafinil/armodafinil
Other Names:
  • Provigil
  • Nuvigil
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 test.
 Drug: Modafinil/armodafinil
Other Names:
  • Provigil
  • Nuvigil


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of minor birth defects [ Time Frame: End of pregnancy through the first year after delivery ]
  2. Incidence of elective termination due to identified anomaly/birth defect or increased risk of anomaly/birth defect [ Time Frame: Baseline and End of pregnancy ]
  3. Incidence of spontaneous abortion (defined as <20 weeks gestation) [ Time Frame: Baseline and End of pregnancy ]
  4. Incidence of fetal death (defined as >=20 weeks gestation [ Time Frame: Baseline and End of pregnancy ]
  5. Incidence of neurodevelopmental problems [ Time Frame: Baseline and End of pregnancy ]
  6. Incidence of Microcephaly [ Time Frame: End of pregnancy ]
  7. Incidence of small size for gestational age [ Time Frame: End of pregnancy ]
    defined as the observed weight of a live born infant or size of a fetus that is lower than expected on the basis of gestational age

  8. Incidence of intrauterine growth restriction (IUGR) [ Time Frame: End of pregnancy ]
    defined as observed fetal weight or birth weight below the 10th percentile for gestational age

  9. Incidence of Low/very low birth weight (LBW/VLBW) [ Time Frame: End of pregnancy ]
    Defines as - Low birth weight: <2500 g, regardless of gestational age and - Very low birth weight: birth weight <1500 g, regardless of gestational age

  10. Incidence of Preterm delivery [ Time Frame: End of pregnancy ]
  11. Incidence of Preeclampsia/pregnancy-induced hypertension (PIH) [ Time Frame: Baseline through End of pregnancy ]
  12. Maternal breastmilk feeding practices [ Time Frame: End of pregnancy through the first year after delivery ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792583


Contacts
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Contact: Registry Call Center 866-404-4106 USMedInfo@tevapharm.com

Locations
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United States, Pennsylvania
Teva Pregnancy Registry Recruiting
West Chester, Pennsylvania, United States, 19380
Sponsors and Collaborators
Cephalon, Inc.
More Information
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Additional Information:

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Responsible Party: Cephalon, Inc.
ClinicalTrials.gov Identifier: NCT01792583    
Other Study ID Numbers: C10953/9022
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc. ( Cephalon, Inc. ):
pregnancy
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Wake Disorders
Narcolepsy
Sleep Disorders, Circadian Rhythm
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
 Mental Disorders
Disorders of Excessive Somnolence
Chronobiology Disorders
Occupational Diseases
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action