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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.
- Autism Spectrum Disorder
- Language Disorder
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You were born very early, before 34 weeks of pregnancy.Specific genetic conditionsYou had a strong bad reaction (like passing out or throwing up) after getting blood drawn before.You are scheduled to be evaluated with the MSEL or BOSCC during the study.Your autism is considered moderate or higher based on a specific scale.You have severe heartburn that isn't being managed well.You were born with a brain malformation.You have been diagnosed with Autism Spectrum Disorder.You are between 2 years 6 months and 5 years 2 months old when the study starts.You have been tested for FRAA status using a validated test outside of research studies.You have epilepsy.You are taking a medication that could interfere with l-leucovorin, like certain types of chemotherapy, antimalarial drugs, immune suppressants or specific antibiotics.You take too much mineral or vitamin supplements, more than what is considered safe for daily intake.You have a history of hurting yourself or others, or have thought about or planned to hurt yourself.You are very ill according to a standard score.You are not growing well or your weight is very low for your age.You have a significant language problem based on a specific questionnaire.You can talk and express yourself like a 4-month-old baby according to the MSEL Expressive Language Scale.The child is being raised speaking English.
- Group 1: L-leucovorin calcium
- Group 2: Placebo
- 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."
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