The Nuvigil and Provigil Pregnancy Registry

Obstructive Sleep Apnea Clinical Trial

Official title:

The Nuvigil (Armodafinil) Tablets [C-IV]/Provigil (Modafinil) Tablets [C-IV] Pregnancy Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01792583
• Other study ID #: C10953/9022
• Status: Terminated
• Start date: June 30, 2009
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Both the prospective and the retrospective data are captured.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 191
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Narcolepsy
• Obstructive Sleep Apnea
• Shift Work Sleep Disorder
• Sleep Apnea, Obstructive
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Drug:
• Modafinil/armodafinil

Locations

Country	Name	City	State
United States	Teva Pregnancy Registry	West Chester	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of minor birth defects		End of pregnancy through the first year after delivery
Secondary	Incidence of elective termination due to identified anomaly/birth defect or increased risk of anomaly/birth defect		Baseline and End of pregnancy
Secondary	Incidence of spontaneous abortion (defined as <20 weeks gestation)		Baseline and End of pregnancy
Secondary	Incidence of fetal death (defined as >=20 weeks gestation		Baseline and End of pregnancy
Secondary	Incidence of neurodevelopmental problems		Baseline and End of pregnancy
Secondary	Incidence of Microcephaly		End of pregnancy
Secondary	Incidence of small size for gestational age	defined as the observed weight of a live born infant or size of a fetus that is lower than expected on the basis of gestational age	End of pregnancy
Secondary	Incidence of intrauterine growth restriction (IUGR)	defined as observed fetal weight or birth weight below the 10th percentile for gestational age	End of pregnancy
Secondary	Incidence of Low/very low birth weight (LBW/VLBW)	Defines as - Low birth weight: <2500 g, regardless of gestational age and - Very low birth weight: birth weight <1500 g, regardless of gestational age	End of pregnancy
Secondary	Incidence of Preterm delivery		End of pregnancy
Secondary	Incidence of Preeclampsia/pregnancy-induced hypertension (PIH)		Baseline through End of pregnancy
Secondary	Maternal breastmilk feeding practices		End of pregnancy through the first year after delivery

External Links

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