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Study details
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Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium

Southwest Autism Research & Resource Center
NCT IDNCT04060017ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

80

Study length

about 5.8 years

Ages

2.5–5

Locations

2 sites in AZ, NY

What this study is about

This trial is testing a treatment for children with autism spectrum disorder (ASD) who have language problems. The goal is to see if leucovorin calcium improves their language skills and other symptoms associated with ASD.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Placebo
  • 2.Take Levoleucovorin Calcium

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IV

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

Antidotes, Deterrents, and Toxicologic Agents

Drug routes

injection (Injection)

Endpoints

Secondary: Evaluate change in autism severity of specific symptoms, Evaluate the change in effects of autism symptoms most problematic to family members, Evaluate the change in social withdrawal autism symptoms, Evaluate the change in stereotypical autism symptoms, Evaluate the overall change in core autism symptoms of social communication, Evaluate the safety and tolerability of L-leucovorin calcium in young children with ASD

Body systems

Psychiatry / Mental Health