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NCT01254045 · ClinicalTrials.gov registry record · Phase 2
Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
A Phase 2 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01254045: Completed Phase 2 study, sponsored by Stanford University.
NCT01254045 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01254045, a Phase 2 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the medication oxytocin is an effective and tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving socially appropriate behaviors and reducing social anxiety.
Primary Outcome
Number of times that eye gaze occurred (i.e., participant looked at female experimenter in the eyes) during 10 minute social challenge task (first 5 minutes social proximity, second 5 minutes social interaction). The social challenge task occurred 50 minutes after internasal dose (of placebo, placebo + oxytocin, or oxytocin) at baseline, week 2, and week 3 visits.
Interventions
- DRUG placebo
- DRUG oxytocin 24IU
- DRUG oxytocin 48IU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-02 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
What the finished NCT01254045 record still lists
NCT01254045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01254045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01254045 about?
NCT01254045 is a clinical study titled "Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome". The purpose of this study is to determine whether the medication oxytocin is an effective and tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving socially appropriate behaviors and reducing social anxiety.
What is the current status of trial NCT01254045?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2007-02. Estimated completion is 2010-01.
What interventions are being tested in trial NCT01254045?
The interventions under investigation include: placebo (DRUG), oxytocin 24IU (DRUG), oxytocin 48IU (DRUG).
Who is sponsoring clinical trial NCT01254045?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01254045's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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