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Hormone Therapy

Growth Hormone Treatment in Children With Phelan McDermid Syndrome

Phase 2
Waitlist Available
Led By Swathi Sethuram, MD
Research Sponsored by Swathi Sethuram
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 12 weeks of growth hormone therapy
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

Phelan McDermid syndrome (PMS) is a rare genetic form of autism spectrum disorder (ASD) due to deletions or mutations in the SHANK3 gene. This is a pilot open labeled trial of growth hormone therapy in children with PMS targeting social withdrawal and repetitive behavior. This research study will include children with PMS between 2-12 years of age who will receive growth hormone daily for 12 weeks, if found to be eligible. The aim of this study is to evaluate the effect of growth hormone on behavioral outcomes such as the aberrant behavior checklist social withdrawal subscale (ABC-SW) and repetitive behavior scale- revised (RBS-R). The effects of growth hormone on visual evoked potentials will also be assessed. Growth hormone increases insulin like growth factor 1 (IGF-1) levels and a previous trial of IGF-1 therapy in PMS children showed improvement in these behavioral scales. Growth hormone has been studied for decades with an excellent safety profile and fewer adverse effects compared to IGF-1 therapy in other conditions. Hence, this may be a viable therapeutic option. There is no treatment currently available for PMS and this trial is therefore extremely important.

Eligible Conditions
  • Phelan-McDermid Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 12 weeks of growth hormone therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 12 weeks of growth hormone therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ABC - Social Withdrawal Subscale
Repetitive Behavior Scale-Revised (RBS-R)
The Sensory Assessment for Neurodevelopmental Disorders (SAND)
+1 more
Secondary study objectives
Change in Auditory Event Related Potentials (AERP)
Visual Evoked Potentials (VEP)

Side effects data

From 2020 Phase 2 trial • 6 Patients • NCT04003207
50%
Increase in appetite
50%
Polyuria/nocturia
50%
Crying spells
50%
Gastroenteritis
50%
Runny nose/cough/sneezing
33%
Fever
33%
Eye/ear infection
33%
Decrease in appetite
33%
Worsening repetitive behavior
17%
Diarrhea
17%
Bruising at injection site
17%
Limping/gait changes
17%
Sweating of hands/feet
17%
Worsening hyperactivity
17%
Disruptive behavior
17%
Sleep disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phelan-McDermid Syndrome

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phelan-McDermid syndromeExperimental Treatment1 Intervention
Patients with Phelan-McDermid syndrome receive 12 weeks of growth hormone therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somatotropin
FDA approved

Find a Location

Who is running the clinical trial?

Swathi SethuramLead Sponsor
Swathi Sethuram, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Alexander Kolevzon, MDStudy DirectorIcahn School of Medicine at Mount Sinai
13 Previous Clinical Trials
516 Total Patients Enrolled
Robert Rapaport, MDStudy DirectorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
50 Total Patients Enrolled
~1 spots leftby Dec 2025