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NCT Number: NCT01362660

A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth

This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).

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Key information

Conditions

Infant Developmental Assessment

Age range

Up to 15 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Tempe, Arizona, United States

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About this study

This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.

Exclusion criteria

There are no exclusion criteria for this study

Treatment and study plan

Unintentional exposure in utero

Other

This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).

Primary outcomes

  1. Bayley Infant Neurodevelopmental Screener

    Time frame: 0-2 Months

  2. Bayley Infant Neurodevelopmental Screener

    Time frame: 8 months

  3. Bayley Infant Neurodevelopmental Screener

    Time frame: 15 months

  4. Receptive-Expressive Emergent Language Test

    Time frame: 0-2 Months

  5. Receptive-Expressive Emergent Language Test

    Time frame: 8 months

  6. Receptive-Expressive Emergent Language Test

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Protocol to Monitor the Neurological Development of Infants With Exposure In-utero From Birth to Aged 15 Months in Tanezumab Clinical Studies at Investigational Sites Overseen by Schulman and Associates Institutional Review Board

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 30, 2011
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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