The Nuvigil and Provigil Pregnancy Registry

February 2, 2024 updated by: Cephalon, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Both the prospective and the retrospective data are captured.

Study Type

Observational

Enrollment (Actual)

191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • West Chester, Pennsylvania, United States, 19380
        • Teva Pregnancy Registry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

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 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
Other Names:
  • Provigil
  • Nuvigil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End of pregnancy through the first year after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of minor birth defects
Time Frame: End of pregnancy through the first year after delivery
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
Time Frame: Baseline and End of pregnancy
Baseline and End of pregnancy
Incidence of spontaneous abortion (defined as <20 weeks gestation)
Time Frame: Baseline and End of pregnancy
Baseline and End of pregnancy
Incidence of fetal death (defined as >=20 weeks gestation
Time Frame: Baseline and End of pregnancy
Baseline and End of pregnancy
Incidence of neurodevelopmental problems
Time Frame: Baseline and End of pregnancy
Baseline and End of pregnancy
Incidence of Microcephaly
Time Frame: End of pregnancy
End of pregnancy
Incidence of small size for gestational age
Time Frame: End of pregnancy
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
Incidence of intrauterine growth restriction (IUGR)
Time Frame: End of pregnancy
defined as observed fetal weight or birth weight below the 10th percentile for gestational age
End of pregnancy
Incidence of Low/very low birth weight (LBW/VLBW)
Time Frame: End of pregnancy
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
Incidence of Preterm delivery
Time Frame: End of pregnancy
End of pregnancy
Incidence of Preeclampsia/pregnancy-induced hypertension (PIH)
Time Frame: Baseline through End of pregnancy
Baseline through End of pregnancy
Maternal breastmilk feeding practices
Time Frame: End of pregnancy through the first year after delivery
End of pregnancy through the first year after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2009

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

February 12, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimated)

February 15, 2013

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C10953/9022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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