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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 : August 13, 2019
Sponsor:
Collaborator:
United BioSource Corporation
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

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

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 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 30, 2027
Estimated Study Completion Date : January 30, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Prospective Cohort
  • Any woman who is pregnant, and was exposed to at least one dose of armodafinil or modafinil within 6 weeks prior to conception and/or during pregnancy
  • The condition of the fetus has not been assessed through prenatal testing such as targeted ultrasound and amniocentesis.
  • Eligible patients may include those where the condition of the fetus was already assessed as normal through early prenatal testing to determine the gestational age or viability within 10 weeks or less from registration.
 Drug: Modafinil/armodafinil
Other Names:
  • Provigil
  • Nuvigil
Retrospective Cohort
  • Any woman who is pregnant, and was exposed to at least one dose of armodafinil or modafinil within 6 weeks prior to conception and/or during pregnancy
  • The condition of the fetus has been assessed through prenatal testing such as targeted ultrasound or amniocentesis.
 Drug: Modafinil/armodafinil
Other Names:
  • Provigil
  • Nuvigil


Outcome Measures
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Primary Outcome Measures :
  1. Overall pregnancy outcome [ Time Frame: Baseline and End of pregnancy ]
    The primary objective is to characterize the pregnancy, fetal and newborn outcomes associated with Nuvigil (armodafinil) or (modafinil) exposure during pregnancy. Overall pregnancy outcome consists of any major congenital defects, alterations in fetal growth (including constitutionally small and large for gestational age infants, as well as growth-restricted infants), spontaneous losses, live births, fetal deaths and elective termination.

  2. Adverse fetal outcomes or congenital anomalies [ Time Frame: Baseline and End of Pregnancy ]
    This consists of any adverse fetal outcomes or congenital anomalies that may be attributable to pregnancy exposure to Nuvigil or Provigil.


Secondary Outcome Measures :
  1. Congenital defects reported [ Time Frame: Baseline and End of pregnancy ]
    This will be a listing of all all congenital defects reported (major and minor).

  2. Adverse pregnancy and neonatal outcomes [ Time Frame: Baseline and End of pregnancy ]
    This will be a complete listing of all adverse pregnancy and neonatal outcomes.


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 designed for open enrollment of all patients who meet the inclusion criteria. The function and activities of the Nuvigil/Provigil Pregnancy Registry will be publicized through direct mailings to obstetricians and pharmacists. Known prescribers identified from marketing sources will be targeted for Registry awareness. A toll-free phone line will be established for patient enrollment and a website containing information about the Registry for both physician and patient recruitment will be available. The Registry will be posted on the FDA website for pregnancy registries, with a direct link to a Nuvigil/Provigil Registry website. For ongoing awareness, information on the Registry will be included in the prescribing information and in the Medication Guides distributed by the pharmacist at the time of dispensing. In addition, patient support groups or condition-related sources of information may be targeted to raise patient awareness of the Registry.
Criteria

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
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

Locations
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United States, Pennsylvania
Teva Pregnancy Registry Recruiting
Horsham, Pennsylvania, United States, 19044
Sponsors and Collaborators
Teva Pharmaceutical Industries, Ltd.
United BioSource Corporation
More Information
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Additional Information:
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Responsible Party: Teva Pharmaceutical Industries, Ltd.
ClinicalTrials.gov Identifier: NCT01792583     History of Changes
Other Study ID Numbers: C10953/9022
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Keywords provided by Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. ):
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
 Signs and Symptoms
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