Levoleucovorin Calcium for Autism

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byRichard E Frye, MD, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Phoenix Children's Hospital

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a liquid form of leucovorin calcium to see if it can help young children with autism improve their language skills and behavior. The study involves young children who have autism and language delays. The treatment aims to enhance brain function and development. Leucovorin calcium has shown potential benefits in improving verbal communication and behavior in children with autism spectrum disorder (ASD) who test positive for cerebral folate receptor autoantibodies.

Eligibility Criteria

This trial is for young children aged between 2.5 and 5 years with Autism Spectrum Disorder (ASD) who have language delays or impairments. They must not have changed their treatments for two months before the study and should maintain them throughout the trial. Children with severe prematurity, certain medical conditions, violent behavior, or allergies to the study product cannot participate.

Inclusion Criteria

English is one of the languages used in raising my child.

I can keep my current non-medical treatments the same during the study.

Your autism has a moderate or higher severity level based on a specific scale.

See 4 more

Exclusion Criteria

You were born very early, before 34 weeks of pregnancy.

I do not take more vitamins or minerals than recommended daily amounts.

You are very sick according to a standard rating scale.

See 14 more

Treatment Details

Interventions

Levoleucovorin Calcium (Other)
Placebo (Other)

Trial OverviewThe trial tests if liquid leucovorin calcium can improve cognitive abilities and behaviors related to ASD in children, focusing on language skills. It involves a comparison between leucovorin calcium and a placebo over approximately six months at two different sites.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: L-leucovorin calciumExperimental Treatment1 Intervention

The liquid form of leucovorin calcium will be dosed by weight, with a target dose of 1mg/kg/day, divided into two daily doses. This product may be taken alone or mixed with liquid. Participants randomized to this arm will receive active treatment for both 12-week phases of the study.

Group II: PlaceboPlacebo Group1 Intervention

The placebo will mimic the experimental treatment in flavor, odor, packaging, and dosing instructions. Participants randomized to this arm will receive placebo for the first 12 weeks of the study, then active treatment for the remaining 12 weeks.