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Folinic Acid as a Treatment for Autism Spectrum Disorder in Children

NCT07630506 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-06-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Folinic Acid

Oral folinic acid administered during the double-blind randomised controlled trial (RCT) phase, followed by open-label folinic acid treatment.

DRUG

Placebo

Matching oral placebo administered during the double-blind randomised controlled trial (RCT) phase.

Sponsors & Collaborators

  • Singapore Health Services

    collaborator OTHER

  • Nanyang Technological University

    collaborator OTHER

  • National University of Singapore

    collaborator OTHER

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Singapore

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07630506 on ClinicalTrials.gov