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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. )

Tracking Information
First Submitted Date February 12, 2013
First Posted Date February 15, 2013
Last Update Posted Date August 13, 2019
Actual Study Start Date June 30, 2009
Estimated Primary Completion Date January 30, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2013)
  • 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.
Original Primary Outcome Measures
 (submitted: February 13, 2013)
  • 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.
Change History Complete list of historical versions of study NCT01792583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 18, 2013)
  • 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.
Original Secondary Outcome Measures
 (submitted: February 13, 2013)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Nuvigil and Provigil Pregnancy Registry
Official Title The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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.
Condition
  • Narcolepsy
  • Obstructive Sleep Apnea
  • Shift Work Sleep Disorder
Intervention Drug: Modafinil/armodafinil
Other Names:
  • Provigil
  • Nuvigil
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 13, 2013)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 30, 2027
Estimated Primary Completion Date January 30, 2027   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Registry Call Center 866-404-4106
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01792583
Other Study ID Numbers C10953/9022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
Study Sponsor Teva Pharmaceutical Industries, Ltd.
Collaborators United BioSource Corporation
Investigators Not Provided
PRS Account Teva Pharmaceutical Industries
Verification Date August 2019