Trial Outcomes & Findings for Intranasal Oxytocin for Infants With Prader-Willi Syndrome (NCT NCT03245762)
NCT ID: NCT03245762
Last Updated: 2020-03-26
Results Overview
Swallow study Overall improvement
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
baseline to day 5
Results posted on
2020-03-26
Participant Flow
Participant milestones
| Measure |
Intranasal Oxytocin
Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.
Oxytocin: 4 IU/day of oxytocin administered via nasal spray device each morning.
|
IN-placebo
Intervention: 4 IU/day of placebo via nasal spray device each morning.
Placebo: 4 IU/day of placebo administered via nasal spray device each morning
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Oxytocin for Infants With Prader-Willi Syndrome
Baseline characteristics by cohort
| Measure |
Intranasal Oxytocin
n=10 Participants
Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.
Oxytocin: 4 IU/day of oxytocin administered via nasal spray device each morning.
|
IN-placebo
n=5 Participants
Intervention: 4 IU/day of placebo via nasal spray device each morning.
Placebo: 4 IU/day of placebo administered via nasal spray device each morning
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to day 5Swallow study Overall improvement
Outcome measures
| Measure |
Intranasal Oxytocin
n=10 Participants
Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.
Oxytocin: 4 IU/day of oxytocin administered via nasal spray device each morning.
|
IN-placebo
n=5 Participants
Intervention: 4 IU/day of placebo via nasal spray device each morning.
Placebo: 4 IU/day of placebo administered via nasal spray device each morning
|
|---|---|---|
|
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a
Improved Competency
|
8 Participants
|
4 Participants
|
|
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a
No Change in Competency'
|
1 Participants
|
1 Participants
|
|
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a
Worsened Competency
|
1 Participants
|
0 Participants
|
Adverse Events
Intranasal Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IN-placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place