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Leucovorin Calcium for Autism Spectrum Disorder

Southwestern Research & Resource Center, Phoenix, AZ

Targeting 3 different conditionsLevoleucovorin Calcium +1 morePhase 2RecruitingLed by Richard E Frye, MD, PhDResearch Sponsored by Phoenix Children's Hospital

Eligibility Criteria Checklist

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

Must have

Diagnosis of Autism Spectrum Disorder

Age between 2 years 6 months and 5 years 2 months at baseline

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 1 year after study completion

Awards & highlights

Study Summary

This trial will study the effects of liquid leucovorin calcium on young children with autism spectrum disorder. Enrollment will last approximately 26 weeks from screening to end of treatment.

Eligible Conditions

Autism Spectrum Disorder
Autism
Language Disorder

Eligibility Criteria

Inclusion Criteria

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

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You have been diagnosed with Autism Spectrum Disorder.

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You are between 2 years 6 months and 5 years 2 months old when the study starts.

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Your autism is considered moderate or higher based on a specific scale.

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You have a significant language problem based on a specific questionnaire.

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You can talk and express yourself like a 4-month-old baby according to the MSEL Expressive Language Scale.

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The child is being raised speaking English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year after study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after study completion 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 measures of expressive language

Secondary outcome measures

Evaluate change in autism severity of specific symptoms

Autistic Disorder

Evaluate the change in adaptive functioning

+9 more

Other outcome measures

Combine presence of FRAA titers and single nucleotide polymorphisms (above) into a predicting equation that will evaluate the probability of positive response to L-leucovorin treatment.

Test if biomarkers (FRAAs) predict clinical response to L-leucovorin

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor

72 Previous Clinical Trials

5,013,482 Total Patients Enrolled

5 Trials studying Autism Spectrum Disorder

774 Patients Enrolled for Autism Spectrum Disorder

Rossignol Medical CenterLead Sponsor

4 Previous Clinical Trials

764 Total Patients Enrolled

4 Trials studying Autism Spectrum Disorder

764 Patients Enrolled for Autism Spectrum Disorder

State University of New York - Downstate Medical CenterOTHER

65 Previous Clinical Trials

12,411 Total Patients Enrolled

3 Trials studying Autism Spectrum Disorder

714 Patients Enrolled for Autism Spectrum Disorder

Media Library

Levoleucovorin Calcium (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04060017 — Phase 2

Autism Spectrum Disorder Research Study Groups: L-leucovorin calcium, Placebo

Autism Spectrum Disorder Clinical Trial 2023: Levoleucovorin Calcium Highlights & Side Effects. Trial Name: NCT04060017 — Phase 2

Levoleucovorin Calcium (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04060017 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what capacity is Levoleucovorin Calcium typically prescribed?

"Levoleucovorin Calcium has been found to effectively address renal dysfunction, joint pain, and osteodystrophy."

Answered by AI

Could you provide a summary of research that has been conducted with Levoleucovorin Calcium?

"Currently, 280 Levoleucovorin Calcium trials are in progress with 88 at Phase 3. Of these clinical studies, a significant portion (88 out of 280) is conducted in Woolloongabba, Queensland but the medication can be found trialled at 15038 distinct sites globally."

Answered by AI

What is the scope of participants involved in this clinical trial?

"Presently, this clinical trial is not accruing any further patients. It was first posted on September 22nd 2020 and last updated October 7th 2022. However, for those hoping to find other studies involving autism spectrum disorder, there are 1143 trials welcoming new participants; additionally, 280 medical centres have Levoleucovorin Calcium active studies open for recruitment."

Answered by AI

Who has been approved to participate in the research protocol?

"The requirements to be accepted into this clinical trial are autism spectrum disorder and an age range between 30 months and 60 months. 80 patients need to be recruited for the study in total."

Answered by AI

Is this study still recruiting participants?

"According to clinicaltrials.gov, the recruitment phase for this medical trial has concluded; initial postings are dated September 22nd 2020 and last updates were made October 7th 2022. However, there are still 1423 other trials actively seeking patients at present."

Answered by AI

What risks do individuals face when taking Levoleucovorin Calcium?

"Levoleucovorin Calcium has been tested in Phase 2 trials, so it was assigned a safety rating of two on our scale. This suggests that some data exists to support the drug's safety but no information is available demonstrating its efficacy."

Answered by AI

Is this experiment seeking out elderly individuals for participation?

"This trial is designed to include patients of a specific age bracket, from 30 months up until 60 months old. In comparison, there are 462 trials that accept individuals below 18 years and 903 for those over 65."

Answered by AI

Recent research and studies

Seminars in Pediatric NeurologyJournal

Treatment of Folate Metabolism Abnormalities in Autism Spectrum Disorder

Frye, Richard E., Daniel A. Rossignol, Lawrence Scahill, Christopher J. McDougle, Harris Huberman, and Edward V. Quadros. 2020. “Treatment of Folate Metabolism Abnormalities in Autism Spectrum Disorder”. Seminars in Pediatric Neurology. Elsevier BV. doi:10.1016/j.spen.2020.100835.

Biomarkers in MedicineJournal

Folate Metabolism Abnormalities in Autism: Potential Biomarkers

Frye, Richard E, John C Slattery, and Edward V Quadros. 2017. “Folate Metabolism Abnormalities in Autism: Potential Biomarkers”. Biomarkers in Medicine. Future Medicine Ltd. doi:10.2217/bmm-2017-0109.

Molecular PsychiatryJournal

Folinic Acid Improves Verbal Communication in Children with Autism and Language Impairment: A Randomized Double-blind Placebo-controlled Trial

Frye, R E, J Slattery, L Delhey, B Furgerson, T Strickland, M Tippett, A Sailey, et al.. 2016. “Folinic Acid Improves Verbal Communication in Children with Autism and Language Impairment: A Randomized Double-blind Placebo-controlled Trial”. Molecular Psychiatry. Springer Science and Business Media LLC. doi:10.1038/mp.2016.168.

Frontiers in NeuroscienceJournal