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IGF-1 for Autism
Study Summary
This trial will test if a new treatment, IGF-1, is safe and effective in children with autism. The children will be given either the treatment or a placebo and then switched after a period of time. The study will measure if the treatment improves socialization, language, and repetitive behaviors.
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 2013 Phase 1 & 2 trial • 44 Patients • NCT01207908Trial Design
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Who is running the clinical trial?
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- My child is between 5 and 12 years old.My kidneys do not work well.You have a language delay (lack of fluent phrase speech) reflected by use of ADOS Module 1 or 2.My liver is not working properly.My child is between 5 and 12 years old.I have high pressure inside my skull.My medications have been stable for 3 months and are safe with IGF-1 treatment.My medications have been stable for 3 months and are safe with IGF-1.My medications have been stable for 3 months and are safe with IGF-1.I have or might have a new tumor.I am considered too ill to safely receive experimental treatment.I have an enlarged heart or heart valve problems.My growth plates have fully matured.My child is between 5 and 12 years old.
- Group 1: IGF-1
- 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
How many individuals are involved in this clinical research?
"Correct. Per the latest updates available on clinicaltrials.gov, this medical research project is now actively recruiting for 10 participants to be sourced from a single site. This trial was first posted in May 2014 and last updated at the end of June 2022."
Does the research protocol permit adults over sixty to participate?
"Eligibility criteria for this trial includes those aged between 5 and 12 years old."
Is this study presently recruiting participants?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently seeking out volunteers with its initial post date on May 1st 2014 and the most recent update occurring on June 30th 2022. The study requires 10 individuals from one site for recruitment purposes."
Has the regulatory agency sanctioned IGF-1 for medical use?
"IGF-1, which is currently in a Phase 2 trial, has been assigned an estimated safety rating of 2 since there have not yet been any studies conducted to determine its efficacy."
Do the criteria for this research project qualify me to participate?
"This research is inviting 10 children between the ages of 5 and 12 with autism spectrum disorder to partake. To qualify, these minors should feature language delay as evident by their assessment via ADOS Module 1 or 2, have been on a medication regimen for at least three months prior to enrolment (on account that it's safe to use in combination with IGF-1)."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Icahn School of Medicine at Mount Sinai: < 24 hours
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