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Hormone Therapy
Growth Hormone for Autism Spectrum Disorder
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 2 and 12 years of age
No prior use of Growth Hormone or IGF-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 12 weeks of growth hormone therapy
Awards & highlights
Study Summary
This trial will use growth hormone to treat Phelan-McDermid syndrome and idiopathic autism. It is double-blind and placebo-controlled, meaning that neither the children nor the researchers will know who is receiving growth hormone or the placebo. The trial will last for six months and will evaluate the children's socialization, language, and repetitive behaviors.
Who is the study for?
This trial is for children aged 2-12 with Phelan-McDermid syndrome or idiopathic autism. They must have open bone growth plates, be on stable treatments for three months, and not used growth hormone before. Kids with visual issues, severe health risks, allergies to growth hormone components, closed bone plates, or serious organ problems can't join.Check my eligibility
What is being tested?
The study tests if growth hormone can help kids with Phelan-McDermid syndrome and idiopathic autism improve social skills, language, and reduce repetitive behaviors. It's a double-blind test where half get the real medicine and half get saline (a placebo), without knowing which one they receive.See study design
What are the potential side effects?
Possible side effects of the growth hormone may include joint pain, swelling due to fluid in the body's tissues (edema), muscle pain, tingling skin sensations (paresthesia), and changes in blood sugar levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 2 and 12 years old.
Select...
I have never used Growth Hormone or IGF-1.
Select...
I have a confirmed SHANK3 gene mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 12 weeks of growth hormone therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 12 weeks of growth hormone therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Evoked Potentials (VEP)
Secondary outcome measures
Aberrant Behavior Checklist (ABC) Social Withdrawal Subscale
Repetitive Behavior Scale-Revised (RBS-R)
Sensory Assessment for Neurodevelopmental Disorders (SAND)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Growth Hormone then SalineExperimental Treatment1 Intervention
12 weeks in each treatment phase (rhGH then placebo) and a four week wash-out period between phases.
Group II: Placebo (saline) then Growth HormonePlacebo Group1 Intervention
12 weeks in each treatment phase (placebo then rhGH) and a four week wash-out period between phases.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Growth Hormone
2014
Completed Phase 4
~1490
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,241 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
166 Patients Enrolled for Autism Spectrum Disorder
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,345 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
425 Patients Enrolled for Autism Spectrum Disorder
Alexander Kolevzon, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
12 Previous Clinical Trials
438 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
307 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidneys do not work well.My growth plates have closed.I have an enlarged heart or heart valve problems.I have been diagnosed with Autism Spectrum Disorder without known genetic causes.I have severe health issues that make growth hormone treatment risky for me.My medication and mental health treatment have been stable for 3 months.I have a confirmed SHANK3 gene mutation.My child is between 2 and 12 years old.I have never used Growth Hormone or IGF-1.You have had an allergic reaction to growth hormone or any part of the medication called mecasermin.My liver is not working properly.I have or might have a new tumor.I have high pressure in my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Growth Hormone then Saline
- Group 2: Placebo (saline) then Growth Hormone
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What precautions should be taken when using Growth Hormone therapeutically?
"The safety of Growth Hormone has been assessed at a 2 by the Power team, as there is clinical data to support its security but not yet any evidence that it can produce results."
Answered by AI
Are there presently any opportunities for patients to partake in this investigation?
"Yes, the clinicaltrials.gov database reveals that this medical trial was made available on January 19th 2022 and is currently open for 45 participants at a single location. The study's listing has been updated as recently as July 24th of the same year."
Answered by AI
How many participants are being recruited for this experiment?
"Affirmatively, according to clinicaltrials.gov, this research study is actively recruiting participants with a commencement date of January 19th 2022 and an updated time of July 24th 2022. Aspiring candidates should know that the trial requires 45 individuals at one location."
Answered by AI
What criteria must be met for a person to qualify as a participant in this trial?
"This clinical trial is designed to study the effects of autistic disorder in those between 2 and 12 years old. Approximately 45 participants will be selected for the experiment."
Answered by AI
Does this research protocol admit octogenarians as participants?
"The requirements for entry into this medical trial indicate that children aged 2 to 12 are eligible."
Answered by AI
Who else is applying?
How old are they?
< 18
What site did they apply to?
Seaver Autism Center for Research & Treatment
What portion of applicants met pre-screening criteria?
Met criteria
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