Levoleucovorin Calcium for Autism

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Richard 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.

Research Team

Richard E Frye, MD, PhD

Principal Investigator

Rossignol Medical Center

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.

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.

Treatment Details

Interventions

• Levoleucovorin Calcium (Other)
• Placebo (Other)

Trial Overview 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.

Participant Groups

Group I: L-leucovorin calcium Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Southwestern Research & Resource Center Phoenix, AZ

Southwestern Autism Research & Resource Center Phoenix, AZ

State University of New York, Downstate Brooklyn, NY

Phoenix Children's Hospital Phoenix, AZ

Who Is Running the Clinical Trial?

Phoenix Children's Hospital

Lead Sponsor

Trials

78

Patients Recruited

5,014,000+

Rossignol Medical Center

Lead Sponsor

Trials

6

Patients Recruited

780+

Southwest Autism Research & Resource Center

Lead Sponsor

Trials

9

Patients Recruited

950+

University of Arizona

Collaborator

Trials

545

Patients Recruited

161,000+

New York State Institute for Basic Research

Collaborator

Trials

7

Patients Recruited

960+

State University of New York - Downstate Medical Center

Collaborator

Trials

67

Patients Recruited

12,100+

United States Department of Defense

Collaborator

Trials

940

Patients Recruited

339,000+

References