Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
191 participants
OBSERVATIONAL
2009-06-30
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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).
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.
Modafinil/armodafinil
Interventions
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Modafinil/armodafinil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
FEMALE
Yes
Sponsors
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Cephalon, Inc.
INDUSTRY
Responsible Party
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Locations
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Teva Pregnancy Registry
West Chester, Pennsylvania, United States
Countries
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Related Links
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Other Identifiers
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C10953/9022
Identifier Type: -
Identifier Source: org_study_id
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