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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: Completed Phase 2 study of Autism Spectrum Disorder, sponsored by Holland Bloorview Kids Rehabilitation Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This will be measured by a change in score on the Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale (0-48, where lower scores indicate improvement)
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT01908205 record still lists
NCT01908205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (56% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01908205's enrollment target sits among peer trials
60 118th of 224 higher than 95 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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