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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

Summary

This trial will study the effects of liquid leucovorin calcium on young children with autism spectrum disorder. It will enroll 80 children between the ages of 2.5 and 5 years across two sites. Participation will last approximately 26 weeks.

Eligible Conditions
  • Language Disorder
  • Autism
  • Autism Spectrum Disorder

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the change in social communication symptoms
Secondary outcome measures
Autistic Disorder
Evaluate the change in adaptive functioning
Evaluate the change in effects of autism symptoms on family members
+6 more
Other outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor
74 Previous Clinical Trials
5,013,666 Total Patients Enrolled
University of ArizonaOTHER
518 Previous Clinical Trials
148,629 Total Patients Enrolled
New York State Institute for Basic ResearchOTHER_GOV
6 Previous Clinical Trials
884 Total Patients Enrolled

Media Library

Levoleucovorin Calcium (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04060030 — Phase 2
Language Disorder Research Study Groups: Placebo, L-leucovorin calcium
Language Disorder Clinical Trial 2023: Levoleucovorin Calcium Highlights & Side Effects. Trial Name: NCT04060030 — Phase 2
Levoleucovorin Calcium (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04060030 — Phase 2
~17 spots leftby Jul 2025