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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

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Placebo
  • 2.Take Levoleucovorin Calcium
PhasePhase 2
DrugLevoleucovorin Calcium
Routeinjection

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low8%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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