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Levoleucovorin Calcium for Autism
Study Summary
This trial will study the effects of liquid leucovorin calcium on young children with autism spectrum disorder. Enrollment will last approximately 26 weeks from screening to end of treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- English is one of the languages used in raising my child.You were born very early, before 34 weeks of pregnancy.I can keep my current non-medical treatments the same during the study.I do not take more vitamins or minerals than recommended daily amounts.You are very sick according to a standard rating scale.You had a strong reaction like fainting or vomiting from a previous blood draw.You are scheduled to undergo specific evaluations during the study.You were born with brain abnormalities.I have a diagnosed genetic syndrome.I have epilepsy.Your autism has a moderate or higher severity level based on a specific scale.You have a history of hurting yourself or others, or have thought about or planned to hurt yourself.You have completed a certain type of evaluation within the last 3 months before joining the study.Can speak and communicate using words or sounds, as tested by the MSEL Expressive Language Scale.I haven't changed my non-medical treatments in the last 2 months.My child is diagnosed with Autism Spectrum Disorder and is between 2.5 and 5.2 years old.My FRAA status has been tested and confirmed outside of research.I am not taking any medications that would badly interact with l-leucovorin.You have a significant language delay based on a specific questionnaire.My weight or BMI is in the lowest 5% for my age and gender.I have or had liver or kidney disease.I have severe heartburn that isn't controlled by medication.
- Group 1: L-leucovorin calcium
- Group 2: Placebo
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Frequently Asked Questions
In what capacity is Levoleucovorin Calcium typically prescribed?
"Levoleucovorin Calcium has been found to effectively address renal dysfunction, joint pain, and osteodystrophy."
Could you provide a summary of research that has been conducted with Levoleucovorin Calcium?
"Currently, 280 Levoleucovorin Calcium trials are in progress with 88 at Phase 3. Of these clinical studies, a significant portion (88 out of 280) is conducted in Woolloongabba, Queensland but the medication can be found trialled at 15038 distinct sites globally."
What is the scope of participants involved in this clinical trial?
"Presently, this clinical trial is not accruing any further patients. It was first posted on September 22nd 2020 and last updated October 7th 2022. However, for those hoping to find other studies involving autism spectrum disorder, there are 1143 trials welcoming new participants; additionally, 280 medical centres have Levoleucovorin Calcium active studies open for recruitment."
Who has been approved to participate in the research protocol?
"The requirements to be accepted into this clinical trial are autism spectrum disorder and an age range between 30 months and 60 months. 80 patients need to be recruited for the study in total."
Is this study still recruiting participants?
"According to clinicaltrials.gov, the recruitment phase for this medical trial has concluded; initial postings are dated September 22nd 2020 and last updates were made October 7th 2022. However, there are still 1423 other trials actively seeking patients at present."
What risks do individuals face when taking Levoleucovorin Calcium?
"Levoleucovorin Calcium has been tested in Phase 2 trials, so it was assigned a safety rating of two on our scale. This suggests that some data exists to support the drug's safety but no information is available demonstrating its efficacy."
Is this experiment seeking out elderly individuals for participation?
"This trial is designed to include patients of a specific age bracket, from 30 months up until 60 months old. In comparison, there are 462 trials that accept individuals below 18 years and 903 for those over 65."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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