Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder
Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the effectiveness of folinic acid in the treatment
of language problems in children with autism spectrum disorder. Folinic acid, also known as
leucovorin, is approved by the U.S. Food and Drug Administration (FDA) to decrease side
effects during cancer chemotherapy. Folinic acid may be helpful in treating language problems
in children with autism spectrum disorder, but this is not known. Therefore, folinic acid is
an investigational new drug for this study. Investigators will enroll a total of 134
participants across all three centers, over a 5 year period and participation will last
between 12 and 24 weeks.
Phase:
Phase 2
Details
Lead Sponsor:
Emory University Phoenix Children's Hospital
Collaborators:
Aprofol Arkansas Children's Hospital Research Institute Emory University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Harvard University