RECRUITING

Treatment of Social and Language Deficits with Leucovorin for Young Children with Autism

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Conditions

Autism Spectrum DisorderLanguage 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 social communication 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 social and communication delays. Participation will last approximately 26 weeks, from screening visit to end of treatment.

Official Title

Treatment of Social and Language Deficits with Leucovorin for Young Children with Autism

Quick Facts

Study Start:2020-10-08
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04060030

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 CriteriaExclusion Criteria
  1. 1. 1. Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R).
  2. 2. Between 2 years 6 months and 5 years 2 months of age at baseline
  3. 3. Folate Receptor Alpha Autoantibody Positive status
  4. 4. Language impairment (Ages and Stage Questionnaire between -1 and -3 SD for Language)
  5. 5. English included in the languages in which the child is being raised
  6. 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.
  7. 7. Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period
  8. 8. Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry
  9. 9. 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.
  10. 10. Ability to attend to social stimulus and tolerate imaging procedures, as determined at the discretion of the investigator
  1. 1. Known FRAA status by clinically validated test performed outside of research studies.
  2. 2. Mineral or vitamin supplementation that exceeds the Tolerable Upper Daily Intake Levels set by the Institute of Medicine (See Table 6 below)
  3. 3. Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior
  4. 4. Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill)
  5. 5. Severe prematurity (\<34 weeks gestation) as determined by medical history
  6. 6. Current uncontrolled gastroesophageal reflux
  7. 7. Current or history of liver or kidney disease as determined by medical history and safety labs
  8. 8. Genetic syndromes
  9. 9. Congenital brain malformations
  10. 10. Epilepsy
  11. 11. Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data
  12. 12. Significant negative reaction (i.e. fainting, vomiting, etc.) as a result of a previous blood draw.
  13. 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 the study.
  14. 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 7 below).
  15. 15. Allergy or Sensitivity to ingredients in the investigational product or placebo
  16. 16. Evaluation with the MSEL or BOSCC within 3 months of entering the study
  17. 17. Planned evaluation with the MSEL or BOSCC during the study
  18. 18. Exclusion Criteria for the MEG recording include:
  19. 1. Ferromagnetic implants, artificial joints, fixation hardware, dental work or shrapnel (additional screening will be completed to determine MRI eligibility)
  20. 2. Ferromagnetic products attached to the body (including hair extensions)
  21. 3. Head circumference greater than 60 cm
  22. 4. A weight greater than 407 lbs. (185 kg)

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, Phoenix AZ

Study Locations (Sites)

Southwestern 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, Phoenix AZ

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 Date2020-10-08
Study Completion Date2025-01

Study Record Updates

Study Start Date2020-10-08
Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Language Disorders