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
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Condition or disease | Intervention/treatment |
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Narcolepsy Obstructive Sleep Apnea Shift Work Sleep Disorder | Drug: Modafinil/armodafinil |
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 |
Group/Cohort | Intervention/treatment |
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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).
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Drug: Modafinil/armodafinil
Other Names:
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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.
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Drug: Modafinil/armodafinil
Other Names:
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- 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
- Incidence of minor birth defects [ Time Frame: 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 [ 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 Microcephaly [ Time Frame: End of pregnancy ]
- 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
- 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
- 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
- Incidence of Preterm delivery [ Time Frame: End of pregnancy ]
- Incidence of Preeclampsia/pregnancy-induced hypertension (PIH) [ Time Frame: Baseline through End of pregnancy ]
- Maternal breastmilk feeding practices [ Time Frame: End of pregnancy through the first year after delivery ]

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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 |
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.

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
Contact: Registry Call Center | 866-404-4106 | USMedInfo@tevapharm.com |
United States, Pennsylvania | |
Teva Pregnancy Registry | Recruiting |
West Chester, Pennsylvania, United States, 19380 |
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 |
pregnancy |
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 |