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The Nuvigil and Provigil Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Teva Pharmaceutical Industries
Sponsor:
Collaborator:
United BioSource Corporation
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01792583
First received: February 12, 2013
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention
Narcolepsy
Obstructive Sleep Apnea
Shift Work Sleep Disorder
Drug: Modafinil/armodafinil

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Overall pregnancy outcome [ Time Frame: Baseline and End of pregnancy ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    This consists of any adverse fetal outcomes or congenital anomalies that may be attributable to pregnancy exposure to Nuvigil or Provigil.


Secondary Outcome Measures:
  • Congenital defects reported [ Time Frame: Baseline and End of pregnancy ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    This will be a complete listing of all adverse pregnancy and neonatal outcomes.


Estimated Enrollment: 300
Study Start Date: June 2009
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792583

Contacts
Contact: Registry Call Center 866-404-4106

Locations
United States, Pennsylvania
Teva Pregnancy Registry Recruiting
Horsham, Pennsylvania, United States
Sponsors and Collaborators
Teva Pharmaceutical Industries
United BioSource Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01792583     History of Changes
Other Study ID Numbers: C10953/9022
Study First Received: February 12, 2013
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
pregnancy

Additional relevant MeSH terms:
Narcolepsy
Parasomnias
Sleep Apnea, Obstructive
Sleep Disorders
Sleep Disorders, Circadian Rhythm
Apnea
Chronobiology Disorders
Disorders of Excessive Somnolence
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Occupational Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on November 20, 2014