Actively Recruiting
Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
Led by Southwest Autism Research & Resource Center · Updated on 2026-04-27
80
Participants Needed
2
Research Sites
303 weeks
Total Duration
On this page
Sponsors
S
Southwest Autism Research & Resource Center
Lead Sponsor
A
Autism Speaks
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 known social and communication delays. Participation will last approximately 26 weeks, from screening visit to end of treatment.
CONDITIONS
Official Title
Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Autism Spectrum Disorder using ADOS-2 or ADI-R
- Aged between 2 years 6 months and 5 years 2 months at baseline
- Positive Folate Receptor Alpha Autoantibody status
- Language impairment indicated by Ages and Stages Questionnaire between -1 and -3 standard deviations for language
- Child is being raised with English as one of the languages
- Autism severity is moderate or higher on the 7-item clinical global impression-severity scale
- Ability to keep all ongoing complementary, dietary, traditional, and behavioral treatments unchanged during the study
- Complementary, dietary, traditional, and behavioral treatments unchanged for two months before study entry
- At least 4 months old expressive language ability as assessed by the MSEL Expressive Language Scale
- Ability to attend to social stimulus and tolerate imaging procedures as judged by the investigator
You will not qualify if you...
- Known Folate Receptor Alpha Autoantibody status from clinical tests outside research
- Mineral or vitamin supplementation exceeding Tolerable Upper Daily Intake Levels
- Significant self-abusive or violent behavior or suicidal ideation, plan, or behavior
- Severely affected children with CGI-Severity Score of 7 (Extremely Ill)
- Severe prematurity before 34 weeks gestation
- Current uncontrolled gastroesophageal reflux
- Current or history of liver or kidney disease
- Presence of genetic syndromes
- Congenital brain malformations
- Epilepsy
- Any medical condition that could risk participant safety or data integrity as determined by the investigator
- Significant negative reaction to previous blood draws (e.g., fainting, vomiting)
- Failure to thrive or body mass index or weight below 5th percentile
- Concurrent treatment with drugs that interact with l-leucovorin (e.g., specific chemotherapy, antimalarial, immune suppressive agents, select antibiotics)
- Allergy or sensitivity to ingredients in the investigational product or placebo
- Evaluation with MSEL or BOSCC within 3 months before the study
- Planned evaluation with MSEL or BOSCC during the study
- For MEG recording: ferromagnetic implants or products, head circumference over 60 cm, weight over 407 lbs (185 kg)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Southwestern Research & Resource Center
Phoenix, Arizona, United States, 85016
Not Yet Recruiting
2
State University of New York, Downstate
Brooklyn, New York, United States, 11203
Actively Recruiting
Research Team
R
Richard E Frye, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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