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NCT02629991 · ClinicalTrials.gov registry record · Phase 2
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
A Phase 2 study of Prader-Willi Syndrome and Hyperphagia, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT02629991: Completed Phase 2 study of Prader-Willi Syndrome and Hyperphagia, sponsored by Montefiore Medical Center.
NCT02629991 is a Phase 2 study of Prader-Willi Syndrome and Hyperphagia that has completed, run by Montefiore Medical Center. The registered enrollment target is 23 participants, below the 69-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02629991, a Phase 2 study of Prader-Willi Syndrome and Hyperphagia, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels.
Primary Outcome
The Hyperphagia Questionnaire (HQ)- Total Score. The HQ is a 11-item clinician-rated instrument that was designed to measure food related behaviors in PWS. Items map onto 3 subscales; Hyperphagic Behavior, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome.
Conditions Studied
Interventions
- DRUG Intranasal Oxytocin (IN-OXT)
- OTHER Matched Placebo
Study Locations (1)
New York
- Montefiore Medical Center, Albert Einstein College of Medicine - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-10 |
| Est. Completion | 2018-05 |
| Phase | Phase 2 |
What the finished NCT02629991 record still lists
NCT02629991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 69-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Prader-Willi Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Intranasal Oxytocin (IN-OXT) is the first listed.
NCT02629991 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02629991 about?
NCT02629991 is a clinical study titled "Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome". The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels.
What is the current status of trial NCT02629991?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2015-10. Estimated completion is 2018-05.
What conditions does trial NCT02629991 study?
This clinical trial studies the following conditions: Prader-Willi Syndrome, Hyperphagia.
What interventions are being tested in trial NCT02629991?
The interventions under investigation include: Intranasal Oxytocin (IN-OXT) (DRUG), Matched Placebo (OTHER).
Who is sponsoring clinical trial NCT02629991?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02629991 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prader-Willi Syndrome
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 NCT02629991's enrollment target sits among peer trials
23 10th of 16 higher than 7 of 16 other Prader-Willi Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prader-Willi Syndrome 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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