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Study Summary
This trial will test if L1-79 is safe and works well in kids with ASD who have an IQ above 70 and who's symptoms are rated as 'severe' by a clinician.
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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Who is running the clinical trial?
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- I am on medication that weakens my immune system.I have been diagnosed with Fragile-X syndrome or Rett syndrome.I do not have any major health issues that would interfere with the study.I need more than 3 medications for conditions related to my autism.I can follow the trial's requirements as per my doctor's opinion.I haven't started or significantly changed my mental health treatment in the last 3 months.I do not have any uncontrolled chronic conditions like seizures, heart disease, or asthma.I am taking medication that affects my heart's electrical cycle.I am not pregnant and agree to use birth control during the study.I am not taking any medications that are not allowed in this study.I am between 12 and 21 years old.I can take pills by myself or have someone who can help me.I live with my parent or primary caregiver.I am taking medications not approved for autism spectrum disorder.I am using or agree to use birth control if I'm sexually active.
- Group 1: Placebo Capsules
- Group 2: L1-79 200 mg or 300 mg Capsules
- 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
At what locations are participants involved in this experiment?
"Currently, this medical trial is running in 5 different sites across Columbia, Orange and Chicago; plus another 5 additional places. As such, it's important to select the closest clinic available for you to minimize your travel demands if accepted into the study."
How many participants have joined this experiment?
"Yamo Pharmaceuticals LLC, the benefactor of this trial, will be administering it from two locations: Thompson Center for Autism and Neurodevelopmental Disorders in Columbia, Missouri; and Thompson Autism Center CHOC in Orange, California. For successful execution of the experiment to take place as planned, 50 participants that meet all inclusion criteria needs to be recruited."
Has the FDA authorized L1-79 for therapeutic use?
"The safety of L1-79 has been evaluated by our team at Power and rated as a 2, due to the presence of data confirming its security but no evidence verifying efficacy from Phase 2 clinical trials."
Are there still openings available to partake in this medical experiment?
"Clinicaltrials.gov reveals that this clinical trial is currently recruiting participants, with the study first posted on January 25th 2022 and last updated on March 7th 2022."
Does the trial encompass elderly individuals aged 80 or over?
"This clinical trial is recruiting young participants aged between 12 and 21. In total, there are 234 studies for minors and 47 for those over 65 years old."
Might I fulfill the prerequisites to join this research project?
"Candidates for this trial must be between 12 and 21 years old, diagnosed with early infantile autism. A total of 50 participants are being recruited."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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