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
What this study is about
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.
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.
Requires travel to a study site
How treatment is administered
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.
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