Leucovorin for Social and Language Deficits in Young Children with Autism
This study is looking at how a liquid medicine called Levoleucovorin Calcium might help young children with Autism Spectrum Disorder (ASD) improve their social communication. Researchers want to see if this medicine can make a difference in social skills and other symptoms of ASD. You might be able to join if your child is between 2.5 and 5 years old, has an ASD diagnosis, and also has language delays. A special blood test for "Folate Receptor Alpha Autoantibody Positive status" is also required. The study will compare Levoleucovorin Calcium to a placebo (an inactive substance) and will follow participants for about 26 weeks to see if there are improvements in social communication symptoms.
- Study design
- This study is an interventional trial, meaning participants will receive either the study drug or a placebo. It plans to enroll 80 children across two locations.
- What's involved
- Participation will last approximately 26 weeks, from the initial screening visit to the end of treatment. You will have visits at Baseline, Week 6, Week 12, and Week 24.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, social communication symptoms, will be measured at Week 24, which is the end of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Richard E Frye, MD, PhD · PRINCIPAL_INVESTIGATOR · Rossignol Medical Center, Phoenix AZ
Who to contact
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What this trial measures
- Evaluate the change in social communication symptomsBaseline, Week 6, Week 12, Week 24
Aberrant Behavior Checklist-2, Social Withdrawal Subscale. The ABC is a 58-item parent-reported measure with ratings in the following domains: irritability, social withdrawal, stereotypic behavior, hyperactivity, and inappropriate speech. Each item is rated from 0 (Not a Problem) to 3 (Severe Problem). The raw score will be reported. The total raw score is the sum of the domain raw scores. A higher raw score in any of the domains indicates more severe problems in that domain; a higher total raw score indicates more severity of stereotypical autism symptoms overall.