← Back to Search

Other

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

Study 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

Select...

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

Select...

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

Select...

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

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.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor

73 Previous Clinical Trials

5,013,908 Total Patients Enrolled

University of ArizonaOTHER

514 Previous Clinical Trials

148,191 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

Frequently Asked Questions

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

Is there a cap on the number of volunteers participating in this medical research?

"Unfortunately, the recruitment for this clinical trial has ended. According to records posted on 10/8/2020 and last updated on 9/26/2022, there are no further opportunities to participate in this study at present. However, if you seek other trials that may suit your needs, 1143 studies related to language disorders are currently enrolling patients and 280 medical tests involving Levoleucovorin Calcium require participants as well."

Answered by AI

Does the trial accept participants beneath a certain age cutoff?

"The parameters for this medical experiment necessitates that participants are between 30 and 60 months of age. There is also an abundance of trials available to those under 18 years old (462) as well as elderly patients (903)."

Answered by AI

Has the US Food & Drug Administration sanctioned Levoleucovorin Calcium?

"Leveraging our team's expertise, Levoleucovorin Calcium received a score of 2. This reflects that it is currently in Phase 2 trials; there are indications of safety but no evidence yet for efficacy."

Answered by AI

Were any previous experiments conducted with Levoleucovorin Calcium?

"Presently, there are 280 trials underway related to Levoleucovorin Calcium. Of these active studies, 88 have reached Phase 3 status. Primarily situated in Woolloongabba, Queensland; though numerous sites across the globe are participating in this research effort with a total of 15078 locations running clinical trials for this drug."

Answered by AI

Who can apply to partake in this scientific inquiry?

"This clinical trial requires 80 participants aged between 2.5 years old and 5.2 years old who have language disorders as indicated by the Ages & Stages Questionnaire (ranging -1 to -3 standard deviations). Additionally, applicants must be diagnosed with Autism Spectrum Disorder through either the ADOS-2 or ADI-R assessment tools, present a positive Folate Receptor Alpha Autoantibody status, use English within their household environment, exhibit moderate or higher levels of autism severity on the 7-item Clinical Global Impression Scale (> 4), maintain all pre-existing treatments for two months prior to entry into this study and possess at"

Answered by AI

What medical concerns is Levoleucovorin Calcium typically employed to address?

"Levoleucovorin Calcium is a commonly prescribed medication for patients with kidney failure. It can also provide relief for conditions such as joint pain, osteodystrophy, and mineral supplementation deficiencies."

Answered by AI

Are there still openings for participants in this medical experiment?

"This particular research programme has concluded its recruitment process, which began on October 8th 2020 and finished up on September 26th 2022. If you are looking for additional studies to participate in, 1143 clinical trials involving language disorders and 280 studies assessing Levoleucovorin Calcium are currently seeking volunteers."

Answered by AI