NCT07630506RecruitingPhase 2
Folinic Acid as a Treatment for Autism Spectrum Disorder in Children
Folinic Acid as a Treatment for Autism Spectrum Disorder in Children: A Double-blind Randomised Placebo-controlled Trial With Open Label Extension (FOLIN-A Trial)
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 184 (estimated)
- First submitted
- 8 May 2026
- Start date
- 19 May 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- KK Women's and Children's Hospital
- Diseases
- Autism
- NCT number
- NCT07630506
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 184
- From 19 May 2025 to the primary completion date, 30 Jun 2027
- 1 site 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
- Current or prior supplementation with folinic acid or other folate preparations (folic acid supplementation permitted)
- Concurrent use of medications known to interfere with folate metabolism (e.g., methotrexate, trimethoprim, fluorouracil, capecitabine, glucarpidase)
Other illness
- Known allergy or intolerance to folinic acid
- 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
Other
- Vitamin B12 (cobalamin) deficiency or pernicious anemia
- Participation in another interventional clinical trial for autism within the past 6 months
- Unable or unwilling to comply with study visits and procedures
Who the study is looking for
- 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
Age in the registry: 3 years to 10 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KK Women's and Children's Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.