Clin2
NCT04060030Possibly a fitRecruiting

Leucovorin for young children with autism language difficulties

Autism Spectrum DisorderLanguage Disorders

Part of Brain & nervous system, Mental health clinical trials.

This Phase 2 study tests whether leucovorin (a vitamin-related medicine) can improve social communication and language in young children with autism. It also looks at safety and whether the results hold while the child stays on their usual therapies and routines.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
80 people
Ages
2.5 years to 5 years
Study type
Interventional

Who can take part

  • Your child has a confirmed autism diagnosis using standard autism testing (ADOS-2 or ADI-R).
  • Your child is between 2 years 6 months and 5 years 2 months old.
  • Blood test shows your child is positive for folate receptor alpha autoantibodies (FRAA).
  • Your child has meaningful language difficulty and speaks English at home/school (English included in your child’s upbringing).
  • Your child can participate in social tasks and tolerate brain-imaging/testing procedures.
  • Your child must keep all current therapies/diets/behavior supports the same for the study period (and for 2 months before joining).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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