This study will evaluate the safety and effectiveness of an investigational drug called leucovorin for improving language skills in children with ASD.

Many children with autism struggle with language and communication. This study will test if an investigational drug called leucovorin helps children with moderate language delays.

Who can participate?

Your child may be eligible if he or she:

  • Is 5 to 12 years old.
  • Has autism spectrum disorder.
  • Has moderate language delay based on a language test.
  • Is enrolled in a stable educational program.
  • Is not on any medication or has been on stable medication for the past six weeks with no planned changes during the study.

What will my family be asked to do?

As part of the study, you and your child will come to Marcus Autism Center for two initial visits. These visits will include common tests of your child’s behavior, language skills and diagnosis. Children with autism and language delay who fit the study will be randomly assigned to receive leucovorin or a look-alike placebo for 12 weeks. In this study, investigators, parents and children will not know the treatment assignment. We call this a double-blind study.

At week 12, all children can participate in 12 weeks of treatment with leucovorin.

All children in the study will be allowed to continue current treatments, such as speech therapy. We do ask that children not start any new treatments during the study

How much time will this take?

The total time of study participation is 24 weeks and one post study follow-up. This study involves 2 screening visits. At regular intervals, participating families will complete telephone interviews as well as in-person assessments of language and behavior at Marcus Autism Center.

What will I receive for participating?

Children will have the opportunity, during the study, to receive leucovorin, which may improve language delay. Families will be offered compensation for time and inconvenience related to participation.

 

Principal InvestigatorLawrence Scahill, MSN, PhD

Sign up now

Email marcusresearch@choa.org and say you’re interested in the Leucovorin Language Study.