Folinic acid vs placebo in young children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, placebo-controlled study evaluating folinic acid in children with autism spectrum disorder. Eligible participants are 3 to 6 years old with a DSM-5 ASD diagnosis confirmed by ADOS-2, who are non-syndromic and meet certain severity criteria. Participants are assigned to receive either folinic acid or placebo to determine its effects on core and associated symptoms. Outcomes focus on communication, social functioning, and behavior, with careful monitoring for safety and tolerability. The study is led by Prof. Adi Aran and conducted at Shaare Zedek Medical Center in Jerusalem.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children aged 3 to 6 years.
* Diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria.
* ASD diagnosis confirmed by Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).
* ASD diagnosis made at least 6 months before screening.
* Non-syndromic ASD, defined as ASD occurring in the absence of a known genetic syndrome, chromosomal abnormality, major congenital anomaly, or identifiable metabolic or neurological disorder.
* CGI-S score ≥ 4.
* ABC-I score ≥ 12.
* SRS-2 total T-score ≥ 66.
* Body weight between 11.45 kg and \<27 kg.

Exclusion Criteria:

* A seizure or a change in antiepileptic medication within 8 weeks prior to randomization.
* Clinically significant abnormalities on physical examination or laboratory testing, including significant impairment of cardiac, hepatic, or renal function.
* Treatment with folinic acid within 3 months prior to randomization.
* Any change in pharmacological treatment, behavioral treatment, home environment, or school setting (other than school holidays) within 4 weeks prior to randomization, or planned changes during study participation.
* Predicted inability or unwillingness to comply with study procedures.
* Use of antifolate medications or other agents known to interfere with folate metabolism (e.g., methotrexate, trimethoprim).

Where it's running

• Shaare Zedek Medical Center
  Jerusalem, N/A = Not Applicable, Israel Recruiting

Study contacts

• Study coordinator: Adi Aran, MD
• Email: aaran@szmc.org.il
• Phone: +97226555414

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.