RECRUITING

Early Treatment of Language Impairment in Young Children with Autism Spectrum Disorder with Leucovorin Calcium

Conditions

Autism Spectrum Disorder Language Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves language as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and known language delays or impairments. Participation will last approximately 26 weeks from screening to end of treatment.

Official Title

Early Treatment of Language Impairment in Young Children with Autism Spectrum Disorder with Leucovorin Calcium

Quick Facts

Study Start:2020-09-22

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04060017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Months to 60 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Autism Spectrum Disorder (as defined below). 2. Between 2 years 6 months and 5 years 2 months of age at baseline 3. Language impairment (Ages and Stage Questionnaire between -1 and -3 SD for Language) 4. Has at least 4 month old expressive language ability as assessed by the MSEL Expressive Language Scale (i.e., Parent answers "yes" to " Voluntary babbling (such as 'bu, bu, bu")" Question #7 on the MSEL Expressive Language Scale. 5. English included in the languages in which the child is being raised 6. Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment, so fulfilling #1 and #4 fulfills this requirement. 6. Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period 7. Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry	1. Known FRAA status by clinically validated test performed outside of research studies. 2. Mineral or vitamin supplementation that exceeds the Tolerable Upper Daily Intake Levels set by the Institute of Medicine (See Table 5 below) 3. Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior 4. Severely affected as defined by CGI-Severity Standard Score = 7 (Extremely Ill) 5. Severe prematurity (\<34 weeks gestation) as determined by medical history 6. Current uncontrolled gastroesophageal reflux 7. Current or history of liver or kidney disease as determined by medical history and safety labs 8. Genetic syndromes 9. Congenital brain malformations 10. Epilepsy 11. Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data 12. Significant negative reaction (i.e. fainting, vomiting, etc.) because of a previous blood draw. 13. Failure to thrive or Body Mass Index \< 5%ile or \<5%ile for weight (male \<11.2kg; female \<10.8kg by CDC 2000 growth charts) at the time of screening. 14. Concurrent treatment with drug that would significantly interact with l-leucovorin such as specific chemotherapy agents, antimalarial and immune suppressive agents and select antibiotics (See Table 6 below). 15. Allergy or Sensitivity to ingredients in the investigational product or placebo 16. Evaluation with the MSEL or BOSCC within 3 months of entering the study 17. Planned evaluation with the MSEL or BOSCC during the study

Inclusion Criteria

Exclusion Criteria

1. Autism Spectrum Disorder (as defined below).
2. Between 2 years 6 months and 5 years 2 months of age at baseline
3. Language impairment (Ages and Stage Questionnaire between -1 and -3 SD for Language)
4. Has at least 4 month old expressive language ability as assessed by the MSEL Expressive Language Scale (i.e., Parent answers "yes" to " Voluntary babbling (such as 'bu, bu, bu")" Question #7 on the MSEL Expressive Language Scale.
5. English included in the languages in which the child is being raised
6. Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment, so fulfilling #1 and #4 fulfills this requirement.
6. Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period 7. Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry

1. Known FRAA status by clinically validated test performed outside of research studies.
2. Mineral or vitamin supplementation that exceeds the Tolerable Upper Daily Intake Levels set by the Institute of Medicine (See Table 5 below)
3. Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior
4. Severely affected as defined by CGI-Severity Standard Score = 7 (Extremely Ill)
5. Severe prematurity (\<34 weeks gestation) as determined by medical history
6. Current uncontrolled gastroesophageal reflux
7. Current or history of liver or kidney disease as determined by medical history and safety labs
8. Genetic syndromes
9. Congenital brain malformations
10. Epilepsy
11. Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data
12. Significant negative reaction (i.e. fainting, vomiting, etc.) because of a previous blood draw.
13. Failure to thrive or Body Mass Index \< 5%ile or \<5%ile for weight (male \<11.2kg; female \<10.8kg by CDC 2000 growth charts) at the time of screening.
14. Concurrent treatment with drug that would significantly interact with l-leucovorin such as specific chemotherapy agents, antimalarial and immune suppressive agents and select antibiotics (See Table 6 below).
15. Allergy or Sensitivity to ingredients in the investigational product or placebo
16. Evaluation with the MSEL or BOSCC within 3 months of entering the study
17. Planned evaluation with the MSEL or BOSCC during the study

Contacts and Locations

Study Contact

Richard E Frye, MD, PhD

CONTACT

(321) 259-7111

DrFrye@RossignolMedicalCenter.com

Principal Investigator

Richard E Frye, MD, PhD

PRINCIPAL_INVESTIGATOR

Rossignol Medical Center

Study Locations (Sites)

Southwestern Autism Research & Resource Center

Phoenix, Arizona, 85016

United States

State University of New York, Downstate

Brooklyn, New York, 11203

United States

Collaborators and Investigators

Sponsor: Southwest Autism Research & Resource Center

Richard E Frye, MD, PhD, PRINCIPAL_INVESTIGATOR, Rossignol Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-22

Study Completion Date2025-01

Study Record Updates

Study Start Date2020-09-22

Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

Autism Spectrum Disorder
Language Disorders