Phase 3
N=18
Folinic Acid in Autism
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03771560 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Aberrant Behavior Checklist (ABC) - Parent Reported Change — -2.4 score on a scale — p=0.56
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- folinic acid (Drug)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aberrant Behavior Checklist (ABC) - Parent Reported Change |
-2.4 | 0.56 |
| PRIMARY Aberrant Behavior Checklist (ABC) - Teacher Reported Change |
1.2 | 0.68 |
| SECONDARY Social Responsiveness Scale (SRS) - Parent Reported Change |
-7.8 | 0.095 |
| SECONDARY Social Responsiveness Scale (SRS) - Teacher Reported Change |
-0.5 | 0.95 |
| SECONDARY Pediatric Quality of Life (PedsQL) - Parent Reported Change |
-0.8 | 0.69 |
Summary
An examination of changes in urinary metabolites with use of folinic acid in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures and academic measures monthly at school with teachers and parents report.
Eligibility Criteria
Inclusion Criteria
- Between ages 5 and 25
Exclusion Criteria
- Not currently taking folinic acid
Data sourced from ClinicalTrials.gov (NCT03771560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.