Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
Phase 2
80
about 5.7 years
2.5–5
2 sites in AZ, NY
About this study
Researchers are testing whether leucovorin calcium, a medication, helps improve social communication and reduce symptoms in young children with autism spectrum disorder (ASD) who have language delays. The trial will last about 26 weeks and involve approximately 80 children aged 2.5 to 5 years old.
Based on ClinicalTrials.gov records.
What participants do
- 1.Placebo
- 2.Take Levoleucovorin Calcium
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
Antidotes, Deterrents, and Toxicologic Agents
injection (Injection)
Primary: Evaluate the change in social communication symptoms
Secondary: Evaluate adverse effect symptoms in young children with ASD, Evaluate change in specific autism symptom severity, Evaluate the change in effects of autism symptoms on family members, Evaluate the change in stereotypical autism symptoms, Evaluate the overall change in core ASD symptoms of social communication, Evaluate the overall change in core ASD symptoms of social communication using a blind observer, Evaluate the safety and tolerability of L-leucovorin calcium in young children with ASD
Psychiatry / Mental Health