NCT04060017Active, not recruitingPhase 2
Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 13 Aug 2019
- Start date
- 22 Sept 2020
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Southwest Autism Research & Resource Center
- Diseases
- Autism
- NCT number
- NCT04060017
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 22 Sept 2020 to the primary completion date, 31 Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Significant negative reaction (i.e. fainting, vomiting, etc.) because of a previous blood draw.
- 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).
- Allergy or Sensitivity to ingredients in the investigational product or placebo
Other illness
- Current or history of liver or kidney disease as determined by medical history and safety labs
- Genetic syndromes
- Epilepsy
- Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data
- 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.
Other
- Known FRAA status by clinically validated test performed outside of research studies.
- Mineral or vitamin supplementation that exceeds the Tolerable Upper Daily Intake Levels set by the Institute of Medicine (See Table 5 below)
- Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior
- Severely affected as defined by CGI-Severity Standard Score = 7 (Extremely Ill)
- Severe prematurity (\<34 weeks gestation) as determined by medical history
- Current uncontrolled gastroesophageal reflux
- Congenital brain malformations
- Evaluation with the MSEL or BOSCC within 3 months of entering the study
- Planned evaluation with the MSEL or BOSCC during the study
Who the study is looking for
- Autism Spectrum Disorder (as defined below).
- Between 2 years 6 months and 5 years 2 months of age at baseline
- Language impairment (Ages and Stage Questionnaire between -1 and -3 SD for Language)
- 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.
- English included in the languages in which the child is being raised
- 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
Age in the registry: 30 months to 60 months · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| State University of New York, Downstate Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Southwestern Autism Research & Resource Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.