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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 : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

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

Detailed Description:
Both prospective and retrospective data are captured.

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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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
Drug: Modafinil/armodafinil
Other Names:
  • Provigil
  • Nuvigil

Retrospective Cohort
Retrospective is define 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.
Drug: Modafinil/armodafinil
Other Names:
  • Provigil
  • Nuvigil




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of minor birth defects [ Time Frame: End of pregnancy through the first year after delivery ]
  2. Incidence of adverse fetal outcomes other than birth defects [ Time Frame: End of pregnancy through the first year after delivery ]
  3. Incidence of major or minor birth defects using initial reporter terms [ Time Frame: End of pregnancy through the first year after delivery ]
    Initial reporter (e.g., patient or healthcare professional)

  4. Incidence of adverse pregnancy outcome attributed to Provigil (modafinil) or Nuvigil (armodafinil) [ Time Frame: Baseline and End of pregnancy ]
  5. Incidence of elective termination due to identified anomaly/birth defect or increased risk of anomaly/birth defect [ Time Frame: Baseline and End of pregnancy ]
  6. Incidence of spontaneous abortion (defined as <20 weeks gestation) [ Time Frame: Baseline and End of pregnancy ]
  7. Incidence of fetal death (defined as >=20 weeks gestation [ Time Frame: Baseline and End of pregnancy ]
  8. Incidence of neurodevelopmental problems [ Time Frame: Baseline and End of pregnancy ]
  9. Incidence of other complications of pregnancy including preterm delivery, preeclampsia/pregnancy-induced hypertension and low/very low birth weight (LBW/VLBW) [ Time Frame: Baseline and End of pregnancy ]


Information from the National Library of Medicine

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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

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 USMedInfo@tevapharm.com

Locations
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United States, Pennsylvania
Teva Pregnancy Registry Recruiting
West Chester, Pennsylvania, United States, 19380
Sponsors and Collaborators
Teva Pharmaceutical Industries, Ltd.
Additional Information:
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Responsible Party: Teva Pharmaceutical Industries, Ltd.
ClinicalTrials.gov Identifier: NCT01792583    
Other Study ID Numbers: C10953/9022
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
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
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