Levoleucovorin Calcium for Autism

Palo Alto (17 mi)

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

My child is diagnosed with Autism Spectrum Disorder and is between 2.5 and 5.2 years old.

Exclusion Criteria

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

I have a diagnosed genetic syndrome.

I have epilepsy.

My FRAA status has been tested and confirmed outside of research.

I am not taking any medications that would badly interact with l-leucovorin.

My weight or BMI is in the lowest 5% for my age and gender.

I have or had liver or kidney disease.

I have severe heartburn that isn't controlled by medication.

Treatment Details

The 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.

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.