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NCT05187377 · ClinicalTrials.gov registry record · Phase 2

A Controlled Trial of Growth Hormone in Phelan-McDermid Syndrome and Idiopathic Autism

A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 2
Development phase
32
Enrollment target

NCT05187377 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 32 participants.

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The verdict

NCT05187377, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 2
Development phase
32 participants
Enrollment target

Study Summary

This clinical trial will use growth hormone as a novel treatment for Phelan-McDermid syndrome (PMS) and idiopathic autism. A double-blind, placebo-controlled crossover trial design will be used in 30 children with idiopathic autism and 15 children with PMS to evaluate the the effects of growth hormone on visual evoked potentials (VEPs), socialization, language, and repetitive behaviors. The researchers expect to provide evidence for the feasibility of using VEPs in PMS, and to show support for growth hormone in ameliorating clinical symptoms of ASD.

Interventions

  • DRUG Saline
  • DRUG Growth Hormone

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2022-01-19
Est. Completion 2025-02-05
Phase Phase 2

What the Registry Record Tells You About NCT05187377

The ClinicalTrials.gov registry entry for NCT05187377 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.

NCT05187377 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05187377 about?

NCT05187377 is a clinical study titled "A Controlled Trial of Growth Hormone in Phelan-McDermid Syndrome and Idiopathic Autism". This clinical trial will use growth hormone as a novel treatment for Phelan-McDermid syndrome (PMS) and idiopathic autism. A double-blind, placebo-controlled crossover trial design will be used in 30 children with idiopathic autism and 15 children with PMS to evaluate the the effects of growth hormo...

What is the current status of trial NCT05187377?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2022-01-19. Estimated completion is 2025-02-05.

What interventions are being tested in trial NCT05187377?

The interventions under investigation include: Saline (DRUG), Growth Hormone (DRUG).

Who is sponsoring clinical trial NCT05187377?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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