Brooklyn, NYNCT04060030Now EnrollingIRB Ready

Autism Clinical Trial in Brooklyn, NY

Access cutting-edge autism treatment through this phase 2 clinical trial at a research site in Brooklyn. Study-provided care at no cost to qualified participants.

Sponsored by Southwest Autism Research & Resource Center

Quick Self-Assessment

See if you qualify for this Brooklyn location

Preparing your pre-screening questions…

Expert Care in Brooklyn

Access autism specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related autism treatment provided free

Apply for This Brooklyn Location

Check if you qualify for this autism clinical trial in Brooklyn, NY

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Brooklyn

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Brooklyn site if eligible
  4. 4Begin participation

About This Autism Study in Brooklyn

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

Sponsor: Southwest Autism Research & Resource Center

Who Can Participate

Inclusion Criteria

1\. Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R).
Between 2 years 6 months and 5 years 2 months of age at baseline
Folate Receptor Alpha Autoantibody Positive status
Language impairment (Ages and Stage Questionnaire between -1 and -3 SD for Language)
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.
Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period
Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry
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.
Ability to attend to social stimulus and tolerate imaging procedures, as determined at the discretion of the investigator

Exclusion Criteria

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 6 below)
Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior
Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill)
Severe prematurity (\<34 weeks gestation) as determined by medical history
Current uncontrolled gastroesophageal reflux
Current or history of liver or kidney disease as determined by medical history and safety labs
Genetic syndromes
Congenital brain malformations
Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data
Significant negative reaction (i.e. fainting, vomiting, etc.) as a result of a previous blood draw.
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.
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).
Allergy or Sensitivity to ingredients in the investigational product or placebo
Evaluation with the MSEL or BOSCC within 3 months of entering the study
Planned evaluation with the MSEL or BOSCC during the study
Ferromagnetic implants, artificial joints, fixation hardware, dental work or shrapnel (additional screening will be completed to determine MRI eligibility)
Ferromagnetic products attached to the body (including hair extensions)
Head circumference greater than 60 cm
A weight greater than 407 lbs. (185 kg)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Brooklyn?

Yes, this clinical trial (NCT04060030) has an active research site in Brooklyn, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Autism Treatment Options in Brooklyn, NY

If you're searching for autism treatment options in Brooklyn, NY, this clinical trial (NCT04060030) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Brooklyn research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced autism specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all autism clinical trials near you to find additional studies recruiting in your area.

More Autism Trials in Brooklyn, NY

See all autism clinical trials recruiting in Brooklyn — not just this study.

Browse Autism Trials in Brooklyn →

Browse More Trials by Condition

Autism TrialsUTI TrialsAll Conditions →

Ready to Join in Brooklyn?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Brooklyn, NY