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Leucovorin for Autism
Phase 2
Recruiting
Led By Richard E Frye, MD, Phd
Research Sponsored by Phoenix Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Folate Receptor Alpha Autoantibody Positive status
Ability to attend to social stimulus and tolerate imaging procedures, as determined at the discretion of the investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, week 16, week 20, week 24
Awards & highlights
Summary
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.
Eligible Conditions
- Autism Spectrum Disorder
- Language Disorder
- Autism
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You haven't made any changes to your complementary, dietary, traditional, or behavioral treatments for at least two months before starting the study.
Select...
You have significant difficulty understanding or using language, as measured by a specific test.
Select...
If you have autism, it needs to be moderate or severe based on a scale that measures how it affects your daily life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, week 16, week 20, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, baseline, week 2, week 4, week 6, week 8, week 10, week 12, week 16, week 20, week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate the change in social communication symptoms
Secondary study objectives
Autistic Disorder
Evaluate the change in adaptive functioning
Evaluate the change in effects of autism symptoms on family members
+6 moreOther study objectives
Demonstrate changes in neuronal activation and connectivity associated with treatment response using non-invasive neuroimaging methods
Evaluate the effect of L-leucovorin on cellular regulatory pathways known to be implicated in social communication
Test if biomarkers (single nucleotide polymorphisms) predict clinical response to L-leucovorin
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: L-leucovorin calciumExperimental Treatment1 Intervention
The liquid form of leucovorin calcium will be dosed by weight, with a target dose of 1mg/kg/day, divided into two daily doses. This product may be taken alone or mixed with liquid. Participants randomized to this arm will receive active treatment for both 12-week phases of the study.
Group II: PlaceboPlacebo Group1 Intervention
The placebo will mimic the experimental treatment in flavor, odor, packaging, and dosing instructions. Participants randomized to this arm will receive placebo for the first 12 weeks of the study, then active treatment for the remaining 12 weeks.
Find a Location
Who is running the clinical trial?
Phoenix Children's HospitalLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a specific genetic condition or syndrome.You have a history of hurting yourself or others, or show signs of thinking about or planning to harm yourself.You have epilepsy, a condition that causes seizures.You haven't made any changes to your complementary, dietary, traditional, or behavioral treatments for at least two months before starting the study.Your head size is larger than 60 cm.You have significant difficulty understanding or using language, as measured by a specific test.You were born with abnormal structures in your brain.You are allergic or sensitive to any of the ingredients in the experimental treatment or the inactive placebo.You are currently taking medications that could have a strong interaction with l-leucovorin, such as certain chemotherapy drugs, antimalarial and immune suppressive medications, and specific antibiotics.You have ongoing, uncontrolled acid reflux or heartburn.You take too many vitamins or minerals, more than what is considered safe by experts.You weigh more than 407 lbs. (185 kg).You have any metal objects or attachments on your body, like hair extensions or other magnetic items.If you have autism, it needs to be moderate or severe based on a scale that measures how it affects your daily life.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: L-leucovorin calcium
Awards:
This trial has 1 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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