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NCT01908205 · ClinicalTrials.gov registry record · Phase 2

Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD)

A Phase 2 study of Autism Spectrum Disorder, sponsored by Holland Bloorview Kids Rehabilitation Hospital.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target
2
Study locations

NCT01908205 is a Phase 2 study of Autism Spectrum Disorder that has completed, run by Holland Bloorview Kids Rehabilitation Hospital. The registered enrollment target is 60 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (56% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01908205, a Phase 2 study of Autism Spectrum Disorder, has completed, sponsored by Holland Bloorview Kids Rehabilitation Hospital.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target
2
Study locations

Study Summary

We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon® has been approved by the U.S. Food and Drug Administration for use in helping women breastfeed, but it has not been approved for use in children with ASD. However, there is previous research conducted that has indicated that after administration of oxytocin, adults with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and anxiety. There is also early research to suggest that children may also benefit in these areas. The purpose of this study is to test if oxytocin works to help children and adolescents with ASD.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Intranasal Oxytocin

Study Locations (2)

Minnesota

  • University of Minnesota - Minneapolis

Ontario

  • Holland Bloorview Kids Rehabilitation Hospital - Toronto

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2013-09
Est. Completion 2016-03
Phase Phase 2

What the Registry Record Tells You About NCT01908205

The ClinicalTrials.gov registry entry for NCT01908205 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (56% lower). The listed sponsor is Holland Bloorview Kids Rehabilitation Hospital, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01908205 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Minnesota, Ontario.

Frequently Asked Questions

What is clinical trial NCT01908205 about?

NCT01908205 is a clinical study titled "Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD)". We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon® has been approved by the U.S. Food and Drug Administration for use in helping women breastfeed, but it has not been approved for use in children with ASD. However, there is previous research conducted that ...

What is the current status of trial NCT01908205?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2013-09. Estimated completion is 2016-03.

What conditions does trial NCT01908205 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder.

What interventions are being tested in trial NCT01908205?

The interventions under investigation include: Placebo (DRUG), Intranasal Oxytocin (DRUG).

Who is sponsoring clinical trial NCT01908205?

This trial is sponsored by Holland Bloorview Kids Rehabilitation Hospital, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01908205 being conducted?

This trial has 2 study locations across Minnesota, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.