RecruitingPhase 2

Folinic Acid as a Treatment for Autism Spectrum Disorder in Children

Singapore184 participantsStarted 2025-05-19

Plain-language summary

Autism spectrum disorder (ASD) is a neurodevelopmental condition that affects communication, behavior, and social interaction in children. Current treatments are limited and mainly focus on managing symptoms. This study aims to evaluate whether folinic acid is safe and effective in improving symptoms of autism spectrum disorder in children. Participants will be randomly assigned to receive either folinic acid or a placebo during the double-blind treatment phase. After this phase, all participants will have the option to receive folinic acid in an open-label extension. The results of this study may help determine whether folinic acid could be a potential treatment option for children with autism spectrum disorder.

Who can participate

Age range

3 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 3 years 0 months to 10 years 11 months at the time of enrolment * Weight ≥ 10 kg and ≤ 30 kg at the time of enrolment * Confirmed diagnosis of Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, supported by standardized diagnostic assessments * Stable on regular behavioral interventions and any medications for at least 6 months prior to enrolment * At least one parent or legal guardian able to understand and complete study questionnaires in English * Written informed consent obtained from a parent or legal guardian Exclusion Criteria: * Known allergy or intolerance to folinic acid * Current or prior supplementation with folinic acid or other folate preparations (folic acid supplementation permitted) * Vitamin B12 (cobalamin) deficiency or pernicious anemia * Concurrent use of medications known to interfere with folate metabolism (e.g., methotrexate, trimethoprim, fluorouracil, capecitabine, glucarpidase) * Known genetic, metabolic, or chromosomal disorder, or structural brain abnormalities * History of epilepsy or seizures (except simple febrile seizures) or current use of antiepileptic or antipsychotic medication * Significant sensory (hearing or visual) or motor impairment * Participation in another interventional clinical trial for autism within the past 6 month…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pervasive Developmental Disorder-Behavior Inventory (PDDBI) Autism Composite T-Score

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT07630506

SponsorKK Women's and Children's Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Study Coordinator

6563947201 folin-a@kkh.com.sg

View on ClinicalTrials.gov More Autism Spectrum Disorder trials