A Folinic Acid Intervention for Autism Spectrum Disorders

Summary

Researchers at Arkansas Children's Hospital Research Institute are conducting a study looking at the effects of Folinic Acid on language in Autism Spectrum Disorder and language impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment (there is no compensation for this visit). If language impairment is verified in the phase 1 screening, then your child will be eligible for phase 2. Phase 2 consists of receiving 12 weeks of folinic acid or an inactive placebo, in addition to several evaluations of your child's abilities and a single blood test. Children that complete phase 2 will be eligible for a 12 week open-label trial of folinic acid which is phase 3.

Timeline

Start

2012-05

Primary completion

2015-11

Completion

2015-11

Outcome

Met primary endpoint

Stopped: “Non-compliance”

paper treatment with high-dose folinic acid for 12 weeks resulted in improvement in verbal communication as compared with placebo PMID 27752075 ↗

Publications

• Frye RE, Slattery J, Delhey L, Furgerson B, Strickland T, Tippett M, Sailey A, Wynne R, Rose S, Melnyk S, Jill James S, Sequeira JM, Quadros EV. Folinic acid improves verbal communication in children with autism and language impairment: a randomized double-blind placebo-controlled trial. Mol Psychiatry. 2018 Feb;23(2):247-256. doi: 10.1038/mp.2016.168. Epub 2016 Oct 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Leucovorin	Small molecule	2 mg/kg	—

Indications