Leucovorin for Autism
Trial Summary
What is the purpose of this trial?
This trial tests a liquid form of leucovorin calcium in young children with autism spectrum disorder (ASD) to see if it improves their social communication and behavior. The study focuses on children who have significant social and communication challenges. The treatment aims to enhance brain function, potentially leading to better communication and interaction skills.
Will I have to stop taking my current medications?
The trial requires that you keep your current treatments, including medications, the same for the study period and that they have not changed for two months before starting the study. However, you cannot take certain drugs that interact with leucovorin, like some chemotherapy agents, antimalarial drugs, immune suppressants, and specific antibiotics.
Is leucovorin safe for use in humans?
How is the drug Levoleucovorin Calcium used in the treatment of autism different from other treatments?
Research Team
Richard E Frye, MD, PhD
Principal Investigator
Rossignol Medical Center, Phoenix AZ
Eligibility Criteria
This trial is for young children aged 2.5 to 5 years with confirmed autism spectrum disorder (ASD) who have social and communication delays, can attend to social stimuli, tolerate imaging procedures, and are being raised with English included in their languages. They must not change any ongoing treatments during the study and should have a moderate or higher level of autism severity.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants receive either placebo or active treatment for 12 weeks under double-blind conditions
Treatment Phase 2
All participants receive active treatment for an additional 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Levoleucovorin Calcium
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phoenix Children's Hospital
Lead Sponsor
Southwest Autism Research & Resource Center
Lead Sponsor
Rossignol Medical Center
Lead Sponsor
University of Arizona
Collaborator
New York State Institute for Basic Research
Collaborator
State University of New York - Downstate Medical Center
Collaborator
Autism Speaks
Collaborator