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Hormone Therapy

Intranasal Oxytocin (IN-OXT) for Prader-Willi Syndrome

Phase 2
Recruiting
Led By Eric Hollander, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization at baseline until endpoint at week 8 (change over 8 weeks)
Awards & highlights

Study Summary

This trial is testing if intranasal OXT (a hormone) is better than placebo at treating symptoms of PWS (a genetic disorder that includes hyperphagia, or excessive hunger). The trial will measure if OXT affects eating behaviors, repetitive behaviors, weight and body composition, quality of life, and hormone levels. If OXT is superior to placebo, this will add to the current knowledge that OXT is an effective treatment for hyperphagia and other symptoms of PWS.

Eligible Conditions
  • Prader-Willi Syndrome
  • Binge Eating

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization at baseline until endpoint at week 8 (change over 8 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization at baseline until endpoint at week 8 (change over 8 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hyperphagia Questionnaire for Clinical Trials
Secondary outcome measures
Aberrant Behavior Checklist
BMI
Body Composition
+5 more
Other outcome measures
Automated, Self-Administered, 24 Hour Recall Diary System
Estrogens
Relationship between weight-based dosing and hyperphagia treatment response

Side effects data

From 2018 Phase 2 trial • 23 Patients • NCT02629991
18%
Fever
18%
Nocturia
18%
Fatigue
9%
Cough
9%
Increased movements, involuntary
9%
Scraped Knee
9%
Shingles
9%
Upper Respiratory Infection
9%
Dry Skin
9%
Headache
9%
Rhinitis Infective
9%
Pneumonia
9%
Worsening eczema
9%
Insomnia
9%
Increased cataplexy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Matched Placebo
Intranasal Oxytocin (IN-OXT)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: Intranasal Oxytocin (IN-OXT)Experimental Treatment1 Intervention
Syntocinon (synthetic oxytocin) will be used in this protocol. Each subject will receive a dose of 16 IU QD and will be instructed to inhale 2 puffs per nostril (4 IU each).
Group II: Placebo Comparator: Matched PlaceboPlacebo Group1 Intervention
Each subject will receive a dose of 16 IU QD, and will be instructed to inhale 2 puffs per nostril (4 IU each).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intranasal Oxytocin (IN-OXT)
2015
Completed Phase 2
~30

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
440 Previous Clinical Trials
581,496 Total Patients Enrolled
3 Trials studying Prader-Willi Syndrome
20,997 Patients Enrolled for Prader-Willi Syndrome
Eric Hollander, MD2.812 ReviewsPrincipal Investigator - Albert Einstein College of Medicine
Montefiore Medical Center
16 Previous Clinical Trials
599 Total Patients Enrolled
2 Trials studying Prader-Willi Syndrome
37 Patients Enrolled for Prader-Willi Syndrome
5Patient Review
It can be difficult to find a professional who is both willing and able to provide the level of care my son needs. After being rejected by many so-called experts, we finally found Dr. Hollander. He was kind, patient, and took the time to fully understand my son's condition. The new medication he prescribed showed dramatic results within days. I would (and have) recommend him to anyone in need of a top-notch psychiatrist.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate size of this research project's participant population?

"Affirmative. Clinicaltrials.gov has records of this medical trial's active recruitment, with the first posting on April 11th 2018 and most recent update taking place August 19th 2022. A total 50 participants are needed for this single-centre study."

Answered by AI

Is participation in this clinical trial still attainable for individuals?

"Affirmative. Clinicaltrials.gov displays the information that this trial, which was published on April 11th 2018, is actively recruiting patients. 50 participants are required from a single site for the study to continue."

Answered by AI

Could I potentially qualify as a subject for this scientific investigation?

"This clinical investigation is looking for 50 pediatric outpatients, between the ages of 5 and 17, that have been diagnosed with royer syndrome. To be considered eligible to participate in this study participants must fulfill all the following criteria: both male and female patients are accepted; they need to be receiving a stable dosage of growth hormone treatment over 3 months prior to screening; no more than one week without taking hormones treatments such as testosterone or estrogen supplements 4 weeks before randomization and until completion on the trial; same goes for metabolic treatments like metformin.; lastly , scoring at least moderate severity on Hyperphagia Questionnaire for Clinical Trials"

Answered by AI

What conditions may be alleviated through the use of Intranasal Oxytocin (IN-OXT)?

"Intranasal Oxytocin (IN-OXT) is a common medication for treating hemorrhage, but can also aid in the labour process and reinforce uterine contraction."

Answered by AI

Are there potential adverse effects of using Intranasal Oxytocin (IN-OXT) therapeutically?

"There is preliminary evidence supporting the safety of IN-OXT, so it earned a score of 2."

Answered by AI

Is the eligibility criteria for this study limited to individuals under 45 years of age?

"Patients aged 5 to 17 are eligible for recruitment into this research project."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome
Eric Hollander 2018. "Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03197662.
All > Oxytocin
~7 spots leftby Apr 2025
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