The Nuvigil and Provigil Pregnancy Registry

NCT01792583 | Terminated DMC

• 1 other identifier: C10953/9022
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Narcolepsy; Obstructive Sleep Apnea; Shift Work Sleep Disorder

Keywords

pregnancy

Outcome Measures

Primary Outcomes (1)

• Incidence of major birth defects

  Major birth defects using Metropolitan Atlanta Congenital Birth Defects Program (MACDP) definitions

  End of pregnancy through the first year after delivery

Secondary Outcomes (12)

• Incidence of minor birth defects

  End of pregnancy through the first year after delivery

• Incidence of elective termination due to identified anomaly/birth defect or increased risk of anomaly/birth defect

  Baseline and End of pregnancy

• Incidence of spontaneous abortion (defined as <20 weeks gestation)

  Baseline and End of pregnancy

• Incidence of fetal death (defined as >=20 weeks gestation

  Baseline and End of pregnancy

• Incidence of neurodevelopmental problems

  Baseline and End of pregnancy

Study Arms (2)

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

Retrospective Cohort

Retrospective is defined 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 examination.

Drug: Modafinil/armodafinil

Interventions

Modafinil/armodafinil DRUG

Also known as: Provigil, Nuvigil

Prospective Cohort; Retrospective Cohort

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Registry is conducted in the US and includes female patients exposed to modafinil and/or armodafinil within 6 weeks prior to becoming pregnant or any time during pregnancy. The Registry is designed for open enrollment of all patients meeting the inclusion/exclusion criteria. Registry enrollment is initiated by either patients or healthcare professionals. Patients who meet the eligibility criteria and provide informed consent will be enrolled into the study.

You may qualify if:

• Reported exposure to brand or generic formulations of Nuvigil (armodafinil) and/or Provigil (modafinil) within 6 weeks prior to becoming pregnant, or during pregnancy
• Patients who provide oral or written informed consent.
• Infant up to 1 year of age born to a female with maternal exposure to armodafinil and/or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.
• Able and willing to provide healthcare professional and secondary contact information, and for the patient herself to be contacted periodically by Registry staff.

You may not qualify if:

• Patients who refuse to provide oral or written informed consent.
• Patients not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.
• Infants whose mother was not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.

Sponsors & Collaborators

• Cephalon, Inc.: lead

Study Sites (1)

Teva Pregnancy Registry

West Chester, Pennsylvania, 19380, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Narcolepsy; Sleep Apnea, Obstructive; Sleep Disorders, Circadian Rhythm

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Chronobiology Disorders; Occupational Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: June 30, 2009
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

US (1)