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N-Acetylcysteine for Autism
Study Summary
This trial will study whether N-acetylcysteine can help reduce repetitive behaviors in children with autism spectrum disorder.
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.Side effects data
From 2015 Phase 3 trial • 302 Patients • NCT01675661Trial Design
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Who is running the clinical trial?
Media Library
- I am currently taking antioxidants or glutathione supplements.You have been diagnosed with a severe psychiatric disorder such as schizophrenia either currently or in the past.My autism diagnosis was confirmed with specific autism assessment tools.You are not willing or able to swallow the study medication during the screening visit.I am between 3 and 12 years old.I have a genetic condition linked to Autism.My physical development shows I am in the earliest stage of puberty.You are in good health and your medical condition is not expected to change during the study.You have at least moderate Restricted and Repetitive Behaviors.
- Group 1: Placebo then N-acetylcysteine
- Group 2: N-acetylcysteine then Placebo
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Why is N-Acetylcysteine often given to patients?
"N-Acetylcysteine has been shown to be an effective line of treatment for corneal ulceration, acute rhinitis, and acetaminophen."
How many people are being asked to participate in this clinical trial?
"That is correct. The trial, which was posted on February 12th 2021 and edited September 5th 2022, as indicated by clinicaltrials.gov, is looking for 24 patients at a single site."
Has N-Acetylcysteine received the green light from the FDA?
"Since N-Acetylcysteine is in Phase 2 clinical trials, there is some data to support its safety but not yet any efficacy. Thus, we scored it as a 2."
Is N-Acetylcysteine a new medication being trialed?
"As of now, there are 40 N-Acetylcysteine trials ongoing with 7 in the third stage. New york City has the most active clinical trials for this medication, but there are a total of 46 sites across the United States conducting research."
Are recruitment efforts still underway for this research project?
"From what is published on clinicaltrials.gov, it seems that this trial is presently looking for 24 individuals from a solitary site. The listing was created on February 12th, 2021 and updated most recently on September 5th, 2022."
Does this research study allow people who are over 25 years old to participate?
"For this particular study, only children aged 3 to 12 are eligible. Out of the 320 total clinical trials taking place, 249 involve minors and 71 involve patients that are senior citizens."
Who would be best suited to help with this clinical trial?
"To be applicable for this study, potential participants must: 1) Be aged 3 to 12 years old (11 months), 2) Pass an MRI safety screening (e.g. no metal in the body), 3) Score at least an 11 on the Children's Yale-Brown Obsessive Compulsive Scale for children with autism spectrum disorder (moderate Restricted and Repetitive Behaviors severity required)."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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