Trial Outcomes & Findings for Intranasal Oxytocin in Hypothalamic Obesity (NCT NCT02849743)
NCT ID: NCT02849743
Last Updated: 2022-10-05
Results Overview
The primary objective of this study is to determine whether treatment with 8 weeks of intranasal OXT (relative to 8 weeks of placebo) will promote weight loss in children and adolescents with brain tumors and hypothalamic obesity syndrome ages 10 to 35 years. Specifically, the primary outcome will be: the difference of the post-treatment weight between the two periods (treatment vs. placebo); the statistical model will include the difference of the baseline weight between the two periods and the sequence (OXT-PBO versus PBO-OXT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Assessed at the beginning and end of each Intervention Period (Intervention 1: Visit 1 to Visit 4 = 8 Weeks, Intervention 2: Visit 5 to Visit 8 = 8 Weeks)
Results posted on
2022-10-05
Participant Flow
Once consent was obtained, participants were reviewed for eligibility and inclusion in the trial. Individuals meeting criteria were randomized. In total, 18 participants signed informed consent and completed in-person screening. 5 of 18 were considered ineligible after screening due to: concomitant medications (2), ECG findings (2), and BMI (1). Intervention Period 1: Week 0 to Week 7, Washout: Week 8 to Week 11, Intervention Period 2: Week 12 to Week 20.
Participant milestones
| Measure |
Syntocinon (= Oxytocin), Then Placebo
1. Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
2. Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) \*Dose Escalation, as appropriate, at 2 Weeks
Syntocinon: The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
Placebo (for Syntocinon): The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
|
Placebo, Then Syntocinon (= Oxytocin)
1. Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
2. Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
Syntocinon: The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
Placebo (for Syntocinon): The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
|
|---|---|---|
|
First Intervention (8 Weeks)
STARTED
|
6
|
7
|
|
First Intervention (8 Weeks)
COMPLETED
|
6
|
6
|
|
First Intervention (8 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Washout (4 Weeks)
STARTED
|
6
|
6
|
|
Washout (4 Weeks)
COMPLETED
|
6
|
6
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (8 Weeks)
STARTED
|
6
|
6
|
|
Second Intervention (8 Weeks)
COMPLETED
|
5
|
6
|
|
Second Intervention (8 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Syntocinon (= Oxytocin), Then Placebo
1. Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
2. Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) \*Dose Escalation, as appropriate, at 2 Weeks
Syntocinon: The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
Placebo (for Syntocinon): The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
|
Placebo, Then Syntocinon (= Oxytocin)
1. Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
2. Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
Syntocinon: The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
Placebo (for Syntocinon): The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
|
|---|---|---|
|
First Intervention (8 Weeks)
Stopping Criteria Met
|
0
|
1
|
|
Second Intervention (8 Weeks)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Intranasal Oxytocin in Hypothalamic Obesity
Baseline characteristics by cohort
| Measure |
Syntocinon (= Oxytocin), Then Placebo
n=6 Participants
1. Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
2. Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks) \*Dose Escalation, as appropriate, at 2 Weeks
Syntocinon: The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
Placebo (for Syntocinon): The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
|
Placebo, Then Syntocinon (= Oxytocin)
n=7 Participants
1. Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
2. Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
Syntocinon: The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
Placebo (for Syntocinon): The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.0 Years
n=5 Participants
|
15.3 Years
n=7 Participants
|
15.3 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 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
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at the beginning and end of each Intervention Period (Intervention 1: Visit 1 to Visit 4 = 8 Weeks, Intervention 2: Visit 5 to Visit 8 = 8 Weeks)Population: In order to be included, participants needed data in Intervention 1 (Block 1) and Intervention 2 (Block 2). 10 of 13 Participants with complete data available for analysis.
The primary objective of this study is to determine whether treatment with 8 weeks of intranasal OXT (relative to 8 weeks of placebo) will promote weight loss in children and adolescents with brain tumors and hypothalamic obesity syndrome ages 10 to 35 years. Specifically, the primary outcome will be: the difference of the post-treatment weight between the two periods (treatment vs. placebo); the statistical model will include the difference of the baseline weight between the two periods and the sequence (OXT-PBO versus PBO-OXT).
Outcome measures
| Measure |
Oxytocin
n=10 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=10 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Weight Loss
Baseline
|
88.3 kg
Interval 74.7 to 108.6
|
91.9 kg
Interval 77.9 to 114.6
|
|
Weight Loss
Change at 8 Weeks
|
1.2 kg
Interval 0.9 to 1.8
|
0.9 kg
Interval -0.2 to 1.6
|
SECONDARY outcome
Timeframe: Assessed during each treatment block: at either initial lower dose at baseline (week 0 & week 12) or increased dose at 2 weeks (week 2 & week 15); 50% of participants at each set.Population: In order to be included participants had to have samples collected during both Intervention 1 and Intervention 2. IV Access was not able to be obtained in some individuals. 7 of 13 Participants had data available for analysis. Specimens were collected during the lower dose (Visit 1 or Visit 5) or the higher dose (Visit 2 or Visit 6). As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
We will determine the immediate peripheral pharmacokinetics of intranasal oxytocin (versus placebo/endogenous oxytocin). In order to minimize participant burden, each participant had the assessment at one time point with either the low or high dose of oxytocin. And at one point during the placebo block. For this exploratory outcome, visits representing lower dose and higher dose oxytocin were Combined versus lower and higher dose placebo.
Outcome measures
| Measure |
Oxytocin
n=7 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=7 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Peripheral Oxytocin Area Under the Curve (AUC)
Baseline
|
101792 Concentration (min*pg/mL)
Interval 92722.0 to 123638.0
|
99110 Concentration (min*pg/mL)
Interval 90692.0 to 132989.0
|
|
Peripheral Oxytocin Area Under the Curve (AUC)
Change at 8 Weeks
|
NA Concentration (min*pg/mL)
As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
NA Concentration (min*pg/mL)
As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intervention 1: Week 2 (Low Dose) or Week 4 (High Dose) and Intervention 2: Week 14 (Low Dose) or Week 16 (High Dose)Population: In order to be included, participants needed data in Intervention 1 (Block 1) and Intervention 2 (Block 2) in order to be included. 11 of 13 Participants with Data for Analysis. As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
Cognitive Restraint at Test Meal Attributable to Oxytocin vs Placebo measured using stop-signal task, stop signal reaction time (SSRT). For this exploratory outcome, in order to minimize participant burden, each participant had the assessment at one time point with either the low or high dose of oxytocin. And at one point during the placebo block for comparison.
Outcome measures
| Measure |
Oxytocin
n=11 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=11 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Cognitive Restraint at Test Meal Attributable to Oxytocin vs Placebo
Baseline
|
282 msec
Interval 255.0 to 326.0
|
247 msec
Interval 170.0 to 276.0
|
|
Cognitive Restraint at Test Meal Attributable to Oxytocin vs Placebo
Change at 8 Weeks
|
NA msec
SSRT was assessed at either the lower dose (Visit 1 or Visit 5) or the higher dose (Visit 2 or Visit 6). As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
NA msec
SSRT was assessed at either the lower dose (Visit 1 or Visit 5) or the higher dose (Visit 2 or Visit 6). As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed during Intervention 1: Week 0 (Dose 1) and Intervention 2: Week 12 (Dose 1)Population: In order to be included, participants had to have data in Intervention 1 (Visit 1, Week 0) and Intervention 2 (Visit 5, Week 12). 9 of 13 Participants had data available for analysis. As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
Within Participant Difference in Calories Consumed Attributable to Oxytocin vs Placebo Dose 1 (Week 0 \& Week 12). Total number of calories consumed during the standardized test meal.
Outcome measures
| Measure |
Oxytocin
n=9 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=9 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Within Participant Difference in Calories Consumed Attributable to Oxytocin vs Placebo Dose 1 (Week 0 & Week 12), as a % of kcal Offered.
Baseline (Week 0 of Intervention)
|
72.4 % of total kcal offered
Interval 59.7 to 75.5
|
72.6 % of total kcal offered
Interval 70.9 to 77.7
|
|
Within Participant Difference in Calories Consumed Attributable to Oxytocin vs Placebo Dose 1 (Week 0 & Week 12), as a % of kcal Offered.
Change at 8 Weeks
|
NA % of total kcal offered
As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
NA % of total kcal offered
As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed during Intervention 1: Week 2 (Dose 2) and Intervention 2: Week 14 (Dose 2).Population: In order to be included, participants had to have data in Intervention 1 (Visit 2, Week 2) and Intervention 2 (Visit 6, Week 14). 9 of 13 Participants had data available for analysis. As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
Within Participant Difference in Calories Consumed Attributable to Oxytocin vs Placebo Dose 2 (Week 2 \& Week 14). Total number of calories consumed during the standardized test meal.
Outcome measures
| Measure |
Oxytocin
n=9 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=9 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Within Participant Difference in Calories Consumed Attributable to Oxytocin vs Placebo Dose 2 (Week 2 & Week 14), as a % of kcal Offered.
Week 2 of Intervention
|
72.6 % of total kcal offered
Interval 66.3 to 78.3
|
67.7 % of total kcal offered
Interval 55.7 to 78.5
|
|
Within Participant Difference in Calories Consumed Attributable to Oxytocin vs Placebo Dose 2 (Week 2 & Week 14), as a % of kcal Offered.
Change at 8 Weeks
|
NA % of total kcal offered
As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
NA % of total kcal offered
As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at the end of each treatment block: Week 8 & Week 20.Population: In order to be included, participants had to have data in Intervention 1 (Visit 4, Week 8) and Intervention 2 (Visit 8, Week 20). 9 of 13 Participants had data available for analysis from the end of both treatment blocks.
Within Participant Difference After Oxytocin vs After Placebo in Resting Energy Expenditure (kcal/kg lean body mass/day). Resting Energy Expenditure (REE) with output of kcal/kg lean body mass/day measured using indirect calorimetry.
Outcome measures
| Measure |
Oxytocin
n=9 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=9 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Within Participant Difference After Oxytocin vs After Placebo in Resting Energy Expenditure (kcal/kg Lean Body Mass/Day)
End of Intervention
|
129.5 kcal/kg lean mass/day
Interval 118.2 to 148.1
|
127.2 kcal/kg lean mass/day
Interval 108.3 to 137.9
|
|
Within Participant Difference After Oxytocin vs After Placebo in Resting Energy Expenditure (kcal/kg Lean Body Mass/Day)
Change at 8 Weeks
|
NA kcal/kg lean mass/day
As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
NA kcal/kg lean mass/day
As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at the end of each treatment block: week 8 & week 20.Population: In order to be included, participants had to have data in Intervention 1 (Visit 4, Week 8) and Intervention 2 (Visit 8, Week 20). 9 of 13 Participants had data available for analysis from the end of both treatment blocks. SSRT was assessed at either the lower dose (Visit 1 or Visit 5) or the higher dose (Visit 2 or Visit 6). As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
Within Participant Difference After Oxytocin vs Placebo in Respiratory Quotient (RQ) measured using indirect calorimetry.
Outcome measures
| Measure |
Oxytocin
n=9 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=9 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Respiratory Quotient (VCO2/VO2)
End of Intervention
|
0.8 Ratio (L C02/L 02)
Interval 0.8 to 0.8
|
0.8 Ratio (L C02/L 02)
Interval 0.8 to 0.9
|
|
Respiratory Quotient (VCO2/VO2)
Change at 8 Weeks
|
NA Ratio (L C02/L 02)
As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
NA Ratio (L C02/L 02)
As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at the end of each treatment block: week 8 & week 20.Population: In order to be included, participants had to have data in Intervention 1 and Intervention 2. 10 of 13 Participants had data available for analysis. As this assessment was only administered once per Intervention, we are not able to calculate/report the change at 8 weeks.
Total % Body Fat measured using dual energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
Oxytocin
n=10 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=10 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Within Participant Difference After Oxytocin vs Placebo in % Body Fat
End of Intervention
|
50.1 percent body fat
Interval 44.1 to 54.3
|
50.6 percent body fat
Interval 45.9 to 55.0
|
|
Within Participant Difference After Oxytocin vs Placebo in % Body Fat
Change at 8 Weeks
|
NA percent body fat
As this assessment was only administered once per Intervention Period, we are not able to calculate/report the change at 8 weeks.
|
NA percent body fat
As this assessment was only administered once per Intervention Period, we are not able to calculate/report the change at 8 weeks.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at the end of each treatment block.Population: Limited data was collected for the skeletal muscle oxidative phosphorylation capacity. The data requires extensive review for quality prior to analysis. The post-processing requirements are extensive. Analyzed data is not available.
Measured using MRI-based post-exercise Creatine Chemical Exchange Saturation Transfer (CrCEST) decline exponential time constant.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed using data from Intervention 1: Screening and Visit 4 (Week 8) and Intervention 2: Visit 5 (Week 12) and Visit 8 (Week 20).Population: In order to be included, participants needed data in Intervention 1 (Block 1) and Intervention 2 (Block 2). 10 of 13 Participants with complete data available for analysis.
Measured using the Dykens Hyperphagia Questionnaire. The Dykens Hyperphagia Questionnaire is a 11-item questionnaire with responses on a scale of 1 to 5. 1 = Not a Problem, 5 = Severe or Frequent Problem. The scale includes three domains: hyperphagic behavior, hyperphagic drive, and hyperphagic severity. There is also a total or overall score which is calculated by combining the scores from each domain. Maximum Possible Score: 55, Minimum Possible Score: 11. Higher scores indicated more severe and/or frequent Hyperphagia.
Outcome measures
| Measure |
Oxytocin
n=10 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=10 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Within Participant Change in Hyperphagia (Total Score) Attributable to Oxytocin vs Placebo
Baseline
|
20 score on a scale
Interval 15.3 to 27.0
|
20.5 score on a scale
Interval 16.5 to 23.8
|
|
Within Participant Change in Hyperphagia (Total Score) Attributable to Oxytocin vs Placebo
Change at 8 Weeks
|
2 score on a scale
Interval -0.8 to 2.8
|
0 score on a scale
Interval -3.3 to 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed using data from Intervention 1: Screening and Visit 4 (Week 8) and Intervention 2: Visit 5 (Week 12) and Visit 8 (Week 20).Population: In order to be included, participants needed data in Intervention 1 (Block 1) and Intervention 2 (Block 2). 10 of 13 Participants had complete data available for analysis.
Within Participant Change in Disinhibition of Eating Attributable to Oxytocin vs Placebo. Measured using the Eating Inventory questionnaire. The Eating Inventory consists of 36 statements where participants respond true or false, 14 questions where participants select a response from 1 (least severe: rarely or not at all) to 4 (most severe: always or very much), one final question askes participants to rate their level of restraint in eating from 1 (no restraint) to 6 (constantly limiting food). The scores are assessed in 3 dimensions: Dietary Restraint (Max Score: 21), Disinhibition (Max Score: 16), and Hunger (Max Score: 14). Within Participant Change in Scores from the Disinhibition of Eating dimension are reported.
Outcome measures
| Measure |
Oxytocin
n=10 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=10 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Within Participant Change in Disinhibition of Eating Attributable to Oxytocin vs Placebo
Baseline
|
8.5 score on a scale
Interval 4.5 to 10.8
|
4 score on a scale
Interval 3.3 to 10.5
|
|
Within Participant Change in Disinhibition of Eating Attributable to Oxytocin vs Placebo
Change at 8 Weeks
|
0 score on a scale
Interval -1.8 to 0.8
|
0 score on a scale
Interval -0.8 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed using data from Intervention 1: Screening and Visit 4 (Week 8) and Intervention 2: Visit 5 (Week 12) and Visit 8 (Week 20)Population: In order to be included, participants had to have data in Intervention 1 and Intervention 2. 11 of 13 Participants had data available for analysis.
The National Institute of Neurological Disorders and Stroke (NINDS) quality of life in neurological disorders (Neuro-QoL) scale is a set of self-reported measures to assess health-related quality of life of adults and children. Individuals rate domains on a scale from 1 (Never/Not at all) to 5 (Always/Very Often). Each response is assigned a value. Values are combined for a total raw score, then converted to a T-Scores (cohort-specific mean 50, SD 10). Higher scores on the sub-scale domains indicate more of the entity. Adult and child scores were combined in analyses.
Outcome measures
| Measure |
Oxytocin
n=11 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=11 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Within Participant Change in Mental and Emotional Health Related Quality of Life Attributable to Oxytocin vs Placebo
Baseline: Anxiety
|
49.9 T-Score
Interval 47.7 to 52.8
|
45.7 T-Score
Interval 37.5 to 55.6
|
|
Within Participant Change in Mental and Emotional Health Related Quality of Life Attributable to Oxytocin vs Placebo
Change at 8 Weeks: Anxiety
|
-2 T-Score
Interval -4.6 to 0.7
|
0 T-Score
Interval 0.0 to 0.0
|
|
Within Participant Change in Mental and Emotional Health Related Quality of Life Attributable to Oxytocin vs Placebo
Baseline: Depression
|
42 T-Score
Interval 36.4 to 49.7
|
36.4 T-Score
Interval 36.4 to 49.9
|
|
Within Participant Change in Mental and Emotional Health Related Quality of Life Attributable to Oxytocin vs Placebo
Change at 8 Weeks: Depression
|
0 T-Score
Interval 0.0 to 3.1
|
0 T-Score
Interval 0.0 to 1.2
|
|
Within Participant Change in Mental and Emotional Health Related Quality of Life Attributable to Oxytocin vs Placebo
Baseline: Cognition
|
50.4 T-Score
Interval 48.6 to 56.6
|
44 T-Score
Interval 39.8 to 51.7
|
|
Within Participant Change in Mental and Emotional Health Related Quality of Life Attributable to Oxytocin vs Placebo
Change at 8 Weeks: Cognition
|
0 T-Score
Interval -4.1 to 0.0
|
1.2 T-Score
Interval 0.0 to 2.0
|
|
Within Participant Change in Mental and Emotional Health Related Quality of Life Attributable to Oxytocin vs Placebo
Baseline: Social Function (Adults) or Peer Interaction (Children)
|
47.9 T-Score
Interval 45.1 to 51.4
|
47.9 T-Score
Interval 38.6 to 60.2
|
|
Within Participant Change in Mental and Emotional Health Related Quality of Life Attributable to Oxytocin vs Placebo
Change at 8 Weeks: Social Function
|
-1.6 T-Score
Interval -4.9 to 0.0
|
-1.8 T-Score
Interval -9.6 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed using data from Intervention 1: Screening and Visit 4 (Week 8) and Intervention 2: Visit 5 (Week 12) and Visit 8 (Week 20).Population: In order to be included, participants had to have data in Intervention 1 and Intervention 2. 9 of 13 Participants had data available for analysis. This assessment was administered for participants who lived in the same house as the caregiver who would complete the assessment.
Within Participant Change in Family Assessment Device-General Function Scale (FAD-GFS) Attributable to Oxytocin vs Placebo. The Family Assessment Device (FAD-GFS) includes 12 statements where individuals select from a scale of 4 responses ranging from Strongly Agree (SA) to Strongly Disagree (SD). Each response has a score ranging from 1 to 4, some of the items are reverse scored (i.e. 1 = 4, 2 = 3, 3 = 2, 4 = 1). Minimum Total Score: 12, Maximum Total Score: 48. The scores for each question are added and then divided by the total number of questions. The Minimum Overall Score: 1, Maximum Overall Score: 4. A score of 2 or above is considered dysfunction.
Outcome measures
| Measure |
Oxytocin
n=9 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=9 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Within Participant Change in Family Assessment Device-General Function Scale (FAD-GFS) Attributable to Oxytocin vs Placebo
Baseline
|
1.6 score on a scale
Interval 1.0 to 2.3
|
1.4 score on a scale
Interval 1.1 to 1.8
|
|
Within Participant Change in Family Assessment Device-General Function Scale (FAD-GFS) Attributable to Oxytocin vs Placebo
Change at 8 Weeks
|
-0.1 score on a scale
Interval -0.5 to 0.1
|
0 score on a scale
Interval 0.0 to 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed using data from Intervention 1: Screening and Visit 4 (Week 8) and Intervention 2: Visit 5 (Week 12) and Visit 8 (Week 20)Population: In order to be included, participants had to have data in Intervention 1 and Intervention 2. 10 of 13 Participants had data available for analysis.
Measured using the Bone Mineral Density in Childhood Study (BMDCS) physical activity questionnaire. The Bone Mineral Density in Childhood Study (BMDCS) questionnaire captures the amount of time spent in physical activity. The assessment asks participants to record the number of hours spent in different categories of physical activity (Min: 0 hours per week, Max: 11+ hours per week).
Outcome measures
| Measure |
Oxytocin
n=10 Participants
Within Participant Change in Body Weight with Oxytocin for 8 Weeks
|
Placebo
n=10 Participants
Within Participant Change in Body Weight with Placebo for 8 Weeks
|
|---|---|---|
|
Within Participant Change in Voluntary Physical Activity Attributable to Oxytocin vs Placebo
Baseline
|
1.3 hours per week of physical activity
Interval 1.2 to 2.0
|
1.1 hours per week of physical activity
Interval 0.3 to 1.5
|
|
Within Participant Change in Voluntary Physical Activity Attributable to Oxytocin vs Placebo
Change at 8 Weeks
|
-0.4 hours per week of physical activity
Interval -1.6 to -0.08
|
-0.1 hours per week of physical activity
Interval -0.6 to 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at the end of each treatment block.Population: Limited data was collected for the Eye Tracking Task. The data requires extensive review for quality prior to analysis. The post-processing requirements are extensive. Analyzed data is not available.
Amount of time spent viewing socially relevant versus socially irrelevant stimuli during eye-tracking.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at the end of each treatment block.Population: EEG task was not completed due to difficulties with equipment. No data collected for analysis.
N170 EEG signal during eye-tracking
Outcome measures
Outcome data not reported
Adverse Events
Syntocinon (Intranasal Oxytocin)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Overall
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Syntocinon (Intranasal Oxytocin)
n=12 participants at risk
1\) Intranasal oxytocin, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
Syntocinon: The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
|
Placebo
n=12 participants at risk
1\) Intranasal placebo, administered 3 times per day (at mealtimes) for 8 weeks (dosage based on weight: 16 IU to 24 IU; dose escalation, if appropriate, occurs at 2 weeks)
Placebo (for Syntocinon): The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
|
Overall
n=12 participants at risk
All Participants from Both Treatment Groups.
|
|---|---|---|---|
|
General disorders
Fatigue
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Psychiatric disorders
Irritability
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
25.0%
3/12 • Number of events 3 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
25.0%
3/12 • Number of events 3 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Gastrointestinal disorders
Rectal Irritation
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Gastrointestinal disorders
Worsening Irritable Bowel Syndrome (IBS)
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Cardiac disorders
Electrocardiogram QT Corrected Interval Prolonged
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
25.0%
3/12 • Number of events 3 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
41.7%
5/12 • Number of events 5 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
33.3%
4/12 • Number of events 4 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Skin and subcutaneous tissue disorders
Dry Lips
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Eye disorders
Eye Disorders - Other (Possible Disc Blurring, Eyelid Twitching)
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Infections and infestations
Infections - Other (Pharyngitis, Sinusitis)
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Investigations
Investigations - Other (Low Free T4)
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
16.7%
2/12 • Number of events 2 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
25.0%
3/12 • Number of events 3 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Investigations
Investigations - Other (Elevated AST)
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
|
Investigations
Investigations - Other (Elevated Bilirubin)
|
0.00%
0/12 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
8.3%
1/12 • Number of events 1 • Adverse Event data were collected from the time of informed consent through the duration of participation (Up to 20 Weeks).
The Safety Monitoring Uniform Report Form (SMURF) was administered at each in-person visit and each telephone check-in visit to assess OXT specific side effects. The full SMURF contains a general inquiry, several questions about daily activities, and modified questions specific to potential OXT side effects.
|
Additional Information
Dr. Shana McCormack
The Children's Hospital of Philadelphia
Phone: (215) 590-3174
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place