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Leucovorin for Autism

Phase 2

Recruiting

Led By Richard E Frye, MD, Phd

Research Sponsored by Phoenix Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Folate Receptor Alpha Autoantibody Positive status

Ability to attend to social stimulus and tolerate imaging procedures, as determined at the discretion of the investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, week 16, week 20, week 24

Awards & highlights

Approved for 5 Other Conditions

Summary

This trial tests a liquid form of leucovorin calcium in young children with autism spectrum disorder (ASD) to see if it improves their social communication and behavior. The study focuses on children who have significant social and communication challenges. The treatment aims to enhance brain function, potentially leading to better communication and interaction skills.

Eligible Conditions

Autism Spectrum Disorder
Language Disorder
Autism

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You haven't made any changes to your complementary, dietary, traditional, or behavioral treatments for at least two months before starting the study.

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You have significant difficulty understanding or using language, as measured by a specific test.

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If you have autism, it needs to be moderate or severe based on a scale that measures how it affects your daily life.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, week 16, week 20, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, week 16, week 20, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, week 16, week 20, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the change in social communication symptoms

Secondary study objectives

Autistic Disorder

Evaluate the change in adaptive functioning

Evaluate the change in effects of autism symptoms on family members

+6 more

Other study objectives

Demonstrate changes in neuronal activation and connectivity associated with treatment response using non-invasive neuroimaging methods

Evaluate the effect of L-leucovorin on cellular regulatory pathways known to be implicated in social communication

Test if biomarkers (single nucleotide polymorphisms) predict clinical response to L-leucovorin

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

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.

0 / 9Eligibility criteria met