Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism

Recruiting Phase 2 Interventional Study
Autism Spectrum Disorder Language Disorders
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
30 Months – 60 Months
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Southwest Autism Research & Resource Center · Other
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About This Trial
The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves social communication as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and kn…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 1\. Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R). 2. Between 2 years 6 months and 5 years 2 months of age at baseline 3. Folate Receptor Alpha Autoantibody Positive status 4. Language impairment (Ages and Stage Questionnaire between -1 …
Contacts

Richard E Frye, MD, PhD

(321) 259-7111

DrFrye@RossignolMedicalCenter.com

CONTACT