Clinical trial · Interventional
Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
A PROTOCOL TO MONITOR FROM BIRTH TO AGE 15 MONTHS THE NEUROLOGICAL DEVELOPMENT OF INFANTS WITH EXPOSURE IN-UTERO IN TANEZUMAB CLINICAL STUDIES AT ALL INVESTIGATIONAL SITES
NCT03031938CI-TRIAL-00052445completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb study.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
| Osteoarthritis | — | UNRESOLVED | — |
| Recurrent Low Back Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Investigational medical product (IMP) administered in parent study | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cohort 1
- description
- Long term observational study of subjects from tanezumab parent study
- interventionNames
- Drug: Investigational medical product (IMP) administered in parent study
Primary outcomes (76)
- measure
- Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
- timeFrame
- Any visit during participants' age from 0 to 2 Months
- description
- Occipital-frontal head circumference of participants in centimeter (cm) was reported.
- measure
- Occipital-frontal Head Circumference at 8 Months of Participant's Age
- timeFrame
- At 8 Months of participants' age
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 2 Months
Show eligibility criteria text
Inclusion Criteria: * Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study. * The infant's mother (who was the tanezumab clinical study participant) must review, agree and sign an informed consent document explaining the details of the perinatal and post natal follow up. Where local regulations mandate, the male parent would also review and sign the informed consent. * Parents or legal guardian must be willing and able to comply with scheduled visits and study procedures. Exclusion Criteria: * There are no exclusion criteria for participating in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.