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NCT01970345 · ClinicalTrials.gov registry record · Phase 2

A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder

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

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT01970345 is a Phase 2 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 3 participants.

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The verdict

NCT01970345, a Phase 2 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of autism. We will use a double-blind, placebo-controlled crossover trial design in five children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments in socialization, language, and repetitive behaviors. We expect to provide evidence for the safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on secondary outcomes of social impairment, language delay, and repetitive behavior, as well as on functional outcomes of global severity.

Interventions

  • DRUG IGF-1
  • DRUG Placebo/saline

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2014-05
Est. Completion 2017-09-13
Phase Phase 2

What the Registry Record Tells You About NCT01970345

The ClinicalTrials.gov registry entry for NCT01970345 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 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 IGF-1 is the first listed.

NCT01970345 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01970345 about?

NCT01970345 is a clinical study titled "A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder". The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of autism. We will use a double-blind, placebo-controlled crossover trial design in five children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments in socialization, language, a...

What is the current status of trial NCT01970345?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2014-05. Estimated completion is 2017-09-13.

What interventions are being tested in trial NCT01970345?

The interventions under investigation include: IGF-1 (DRUG), Placebo/saline (DRUG).

Who is sponsoring clinical trial NCT01970345?

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.