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The Nuvigil and Provigil Pregnancy Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01792583
Recruitment Status : Recruiting
First Posted : February 15, 2013
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
United BioSource Corporation
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

February 12, 2013
February 15, 2013
May 16, 2018
June 30, 2009
January 30, 2027   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • Overall pregnancy outcome [ Time Frame: Up to 1 year after giving birth ]
    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.
  • Adverse fetal outcomes or congenital anomalies [ Time Frame: Up to 1 year after giving birth ]
    This consists of any adverse fetal outcomes or congenital anomalies that may be attributable to pregnancy exposure to Nuvigil or Provigil.
Complete list of historical versions of study NCT01792583 on ClinicalTrials.gov Archive Site
  • Congenital defects reported [ Time Frame: Baseline and End of pregnancy ]
    This will be a listing of all all congenital defects reported (major and minor).
  • 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.
  • Congenital defects reported [ Time Frame: Up to 1 year after giving birth ]
    This will be a listing of all all congenital defects reported (major and minor).
  • Adverse pregnancy and neonatal outcomes [ Time Frame: Up to 1 year after giving birth ]
    This will be a complete listing of all adverse pregnancy and neonatal outcomes.
Not Provided
Not Provided
 
The Nuvigil and Provigil Pregnancy Registry
The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry
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.
Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
12 Months
Not Provided
Non-Probability Sample
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.
  • Narcolepsy
  • Obstructive Sleep Apnea
  • Shift Work Sleep Disorder
Drug: Modafinil/armodafinil
Other Names:
  • Provigil
  • Nuvigil
  • 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.
    Intervention: Drug: Modafinil/armodafinil
  • 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.
    Intervention: Drug: Modafinil/armodafinil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Same as current
January 30, 2027
January 30, 2027   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Older Adult
Yes
Contact: Registry Call Center 866-404-4106
United States
 
 
NCT01792583
C10953/9022
Yes
Not Provided
Not Provided
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
Teva Pharmaceutical Industries, Ltd.
United BioSource Corporation
Not Provided
Teva Pharmaceutical Industries
May 2018