Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
Recruiting
Phase 2
Interventional Study
Autism Spectrum Disorder
Language Disorders
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 30 Months – 60 Months
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Southwest Autism Research & Resource Center · Other
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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 kn…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 1\. Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R).
2. Between 2 years 6 months and 5 years 2 months of age at baseline
3. Folate Receptor Alpha Autoantibody Positive status
4. Language impairment (Ages and Stage Questionnaire between -1 …
Contacts