Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-60
SponsorSouthwest Autism Research & Resource Center
About this trial
The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves social communication as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and known social and communication delays. Participation will last approximately 26 weeks, from screening visit to end of treatment.
Eligibility criteria
Qualifiers
1. Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R).
Between 2 years 6 months and 5 years 2 months of age at baseline
Folate Receptor Alpha Autoantibody Positive status
Language impairment (Ages and Stage Questionnaire between -1 and -3 SD for Language)
Disqualifiers
Known FRAA status by clinically validated test performed outside of research studies.
Mineral or vitamin supplementation that exceeds the Tolerable Upper Daily Intake Levels set by the Institute of Medicine (See Table 6 below)
Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior
Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill)
Trial design
Treatments tested in this trial
- Levoleucovorin Calcium
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Southwest Autism Research & Resource Center
Lead sponsor
Autism Speaks
Collaborator
State University of New York - Downstate Medical Center
Collaborator
Source ClinicalTrials.gov