Clinical trial Recruiting at 1 site Observational Ages 2 and up

Characterizing FOXP1-related neurodevelopmental disorders

Official title: The Seaver Autism Center for Research and Treatment - Assessment Core

Run by Icahn School of Medicine at Mount Sinai · NCT03718923 · Data updated 2026-11-12

This study is trying to learn more about how changes in the FOXP1 gene affect development and behavior in people with developmental delays and autism traits.

Quick facts

Study typeObservational
Ages2 Years and up
SexAll
Enrollment50 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedMarch 28, 2016
Main results expectedMay 2028
Study endsMay 2028
Registry record updatedOctober 6, 2026
Trial IDNCT03718923 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 2 years and older with a documented pathogenic variant in the FOXP1 gene.

Probably not a fit

Patients without a FOXP1 gene variant or those under 2 years of age may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on individuals with a variant in the FOXP1 gene, which is associated with global developmental delays and autism spectrum disorder traits. Participants will undergo a series of developmental, behavioral, and medical assessments over three days, including the Autism Diagnostic Observation Schedule (ADOS) and various sensory evaluations. The goal is to better understand the neurodevelopmental deficits related to FOXP1 gene disruptions through comprehensive evaluations and genetic analysis.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of FOXP1-related neurodevelopmental disorders.

How similar studies have gone: Other studies have shown success in characterizing genetic neurodevelopmental disorders, making this approach promising.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Eligible participants must have a documented variant affecting the FOXP1 gene that the research team determines to be likely or definitely pathogenic.
* Eligible participants must be at least 2 years of age.

Exclusion Criteria:

* none

Where it's running

  • The Seaver Autism Center for Research and Treatment
    New York, New York, United States
    Recruiting

Study contacts

  • Principal investigator: Elodie Drapeau, Ph.D. — Icahn School of Medicine at Mount Sinai
  • Study coordinator: Seaver Autism Center
  • Email: TheSeaverCenter@mssm.edu
  • Phone: 212-241-0961

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.