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Growth Factor

IGF-1 for Autism

Phase 2
Waitlist Available
Led By Alexander Kolevzon, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children between the ages of 5-12 years of age
Children between the ages of 5-12 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 1 - week 4 and 12, phase 2 - week 4 and 8
Awards & highlights

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.

Who is the study for?
This trial is for children aged 5-12 with Autism Spectrum Disorder, confirmed by specific diagnostic tools. They must have a language delay and be on stable medication regimens that are safe with IGF-1 for three months prior to joining. Children can't join if they have certain medical conditions like closed epiphyses, tumors, high brain pressure, liver or kidney issues, heart enlargement/valve problems, or allergies to IGF-1.Check my eligibility
What is being tested?
The study tests the effects of Insulin-Like Growth Factor-1 (IGF-1) versus a placebo in improving socialization, language skills, and repetitive behaviors in autistic children. It's a small-scale double-blind trial where neither the participants nor researchers know who receives IGF-1 or placebo during the study period.See study design
What are the potential side effects?
Potential side effects of IGF-1 treatment could include reactions at the injection site since it's similar to insulin but may also affect growth due to its role in development. The exact side effects aren't listed here but would typically be monitored closely given this is a pilot study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 5 and 12 years old.
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My child is between 5 and 12 years old.
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My medications have been stable for 3 months and are safe with IGF-1.
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My child is between 5 and 12 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 1 - week 4 and 12, phase 2 - week 4 and 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 1 - week 4 and 12, phase 2 - week 4 and 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aberrant Behavior Checklist - Social Withdrawal Subscale
Secondary outcome measures
Caregiver Strain
Children's Yale-Brown Obsessive Compulsive Disorder Scale for Pervasive Developmental Disorders
Repetitive Behavior
+3 more

Side effects data

From 2013 Phase 1 & 2 trial • 44 Patients • NCT01207908
41%
Headache
23%
Nausea and vomiting
18%
Leg pain
14%
fever
14%
Back pain
5%
rash and skin welt
5%
Foot pain
5%
Finger injury
5%
seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Steroid Treatment Alone
IGF-1

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IGF-1Experimental Treatment1 Intervention
Randomized, placebo-controlled, crossover format with 12 weeks in each treatment arm (IGF-1 and placebo), separated by a four-week wash-out phase. Dose titration will be initiated at 0.04 mg/kg twice daily by subcutaneous injection, and increased, as tolerated, every week by 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily. Doses may be decreased according to tolerability by 0.04 mg/kg per dose. Medication will be administered twice daily with meals, and preprandial glucose monitoring will be performed by parents at treatment initiation, prior to each injection, and until a well tolerated dose is established.
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IGF-1
2010
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
852 Previous Clinical Trials
535,929 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
208 Patients Enrolled for Autism Spectrum Disorder
Autism Science FoundationOTHER
4 Previous Clinical Trials
190 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
180 Patients Enrolled for Autism Spectrum Disorder
Alexander Kolevzon, MD4.34 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
12 Previous Clinical Trials
480 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
349 Patients Enrolled for Autism Spectrum Disorder
5Patient Review
Dr. Alexander Kolevzon is a caring and attentive doctor who went above and beyond for my son. We are grateful to have him as our physician.

Media Library

IGF-1 (Growth Factor) Clinical Trial Eligibility Overview. Trial Name: NCT01970345 — Phase 2
Autism Spectrum Disorder Research Study Groups: IGF-1, Placebo
Autism Spectrum Disorder Clinical Trial 2023: IGF-1 Highlights & Side Effects. Trial Name: NCT01970345 — Phase 2
IGF-1 (Growth Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01970345 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

Does the research protocol permit adults over sixty to participate?

"Eligibility criteria for this trial includes those aged between 5 and 12 years old."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

Who else is applying?

What state do they live in?
New York
Missouri
Connecticut
How old are they?
< 18
18 - 65
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I want to help my son.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Icahn School of Medicine at Mount Sinai: < 24 hours
Typically responds via
Email
~0 spots leftby Mar 2025