drugset / Trial / NCT07630506
Folinic Acid as a Treatment for Autism Spectrum Disorder in Children
Phase 2
Recruiting
184 enrolled
KK Women's and Children's Hospital
Nanyang Technological University · collabNational University of Singapore · collabSingapore Health Services · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-05-19
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leucovorin | Small molecule | 2 mg/kg | Oral |