Trial Outcomes & Findings for Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD) (NCT NCT01908205)
NCT ID: NCT01908205
Last Updated: 2025-07-16
Results Overview
This will be measured by a change in score on the Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale (0-48, where lower scores indicate improvement)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
12 and 24 weeks
Results posted on
2025-07-16
Participant Flow
Participant milestones
| Measure |
Intranasal Oxytocin (Syntocinon)
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Intranasal Oxytocin
|
Placebo
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
25
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Intranasal Oxytocin (Syntocinon)
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Intranasal Oxytocin
|
Placebo
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Fifty-four youth completed the trial. Six withdrew (5 active, 1 placebo)
Baseline characteristics by cohort
| Measure |
Intranasal Oxytocin (Syntocinon)
n=25 Participants
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Intranasal Oxytocin
|
Placebo
n=29 Participants
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Placebo
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants • Fifty-four youth completed the trial. Six withdrew (5 active, 1 placebo)
|
29 Participants
n=7 Participants • Fifty-four youth completed the trial. Six withdrew (5 active, 1 placebo)
|
54 Participants
n=5 Participants • Fifty-four youth completed the trial. Six withdrew (5 active, 1 placebo)
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants • Fifty-four youth completed the trial. Six withdrew (5 active, 1 placebo)
|
0 Participants
n=7 Participants • Fifty-four youth completed the trial. Six withdrew (5 active, 1 placebo)
|
0 Participants
n=5 Participants • Fifty-four youth completed the trial. Six withdrew (5 active, 1 placebo)
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • Fifty-four youth completed the trial. Six withdrew (5 active, 1 placebo)
|
0 Participants
n=7 Participants • Fifty-four youth completed the trial. Six withdrew (5 active, 1 placebo)
|
0 Participants
n=5 Participants • Fifty-four youth completed the trial. Six withdrew (5 active, 1 placebo)
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 and 24 weeksThis will be measured by a change in score on the Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale (0-48, where lower scores indicate improvement)
Outcome measures
| Measure |
Intranasal Oxytocin
n=25 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=29 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
Baseline - Week 12
|
-2.43 units on a scale
Interval -5.06 to 0.21
|
-3.06 units on a scale
Interval -5.28 to -0.84
|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
Baseline- Week 24
|
-1.34 units on a scale
Interval -4.22 to 1.55
|
-3.03 units on a scale
Interval -5.6 to -0.47
|
SECONDARY outcome
Timeframe: 12 WeeksThis will be measured by a change in score the Revised Eyes Test (0- 28; where higher scores indicate better performance/improvement) Baseline to Week 12
Outcome measures
| Measure |
Intranasal Oxytocin
n=25 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=29 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
|
0.14 score on a scale
Interval -1.57 to 1.3
|
-0.29 score on a scale
Interval -1.58 to 1.0
|
SECONDARY outcome
Timeframe: 12 WeeksThis will be measured by improvement on the Let's Face it! Skills Battery from Baseline to Week 12 Social Cognition (higher score=better outcome) a. Let's Face It Skills Battery; i. Matchmaker (0-100); ii. Faces (0-100); iii. Houses (0-100)
Outcome measures
| Measure |
Intranasal Oxytocin
n=25 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=29 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
Let's Face It Matchmaker
|
4.50 units on a scale
Interval -0.29 to 9.28
|
5.90 units on a scale
Interval 2.22 to 9.59
|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
Let's Face It Faces
|
6.20 units on a scale
Interval 2.96 to 9.45
|
1.52 units on a scale
Interval -2.41 to 5.45
|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
Let's Face It Houses
|
4.94 units on a scale
Interval -1.14 to 11.02
|
2.07 units on a scale
Interval -4.53 to 8.66
|
SECONDARY outcome
Timeframe: 12 WeeksThis will be measured by improvement on the Behavioral Assessment System for Children (BASC-2) from Baseline to Week 12 Behavioral Assessment System for Children (higher score=positive response); i. \*Social Skills: age 6 to 11 (18-69); age 12 to 17 (21-70); ii. Functional Communication: age 6 to 11 (10-66); age 12 to 17 (10-64); iii. Withdrawal age 6-11 (21- 62) ; age 12-17 (14-42) \* only social subscales of BASC-2 reported
Outcome measures
| Measure |
Intranasal Oxytocin
n=25 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=29 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
BASC-2 Social Skills
|
1.40 score on a scale
Interval 0.07 to 2.74
|
0.43 score on a scale
Interval -0.75 to 1.61
|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
BASC-2 Withdrawal
|
-1.38 score on a scale
Interval -2.82 to 0.07
|
-1.74 score on a scale
Interval -3.12 to -0.36
|
SECONDARY outcome
Timeframe: 12 WeeksThis will be measured by the Clinical Global Impressions - Improvement Scale - Social (CGI-I-Social) a) Clinical Global Impressions - Social Scale (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as a social responder (achieving a score of 1 or 2 on the scale).
Outcome measures
| Measure |
Intranasal Oxytocin
n=29 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=25 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Number of Participant Considered Social Responders
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksThis will be measured by improvement on the Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) from Baseline to Week 12 -lower score= positive response (0-20)
Outcome measures
| Measure |
Intranasal Oxytocin
n=25 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=29 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors
|
-2.77 units on a scale
Interval -4.2 to -1.34
|
-2.99 units on a scale
Interval -4.26 to -1.72
|
SECONDARY outcome
Timeframe: 12 WeeksThis will be measured by improvement on the Repetitive Behavior Scale (RBS-R)(0-129; where lower score= positive response) from Baseline to Week 12
Outcome measures
| Measure |
Intranasal Oxytocin
n=25 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=29 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors
|
-6.74 units on a scale
Interval -12.52 to -0.96
|
-4.62 units on a scale
Interval -10.05 to 0.81
|
SECONDARY outcome
Timeframe: 12 WeeksThis will be measured by the Child and Adolescent Symptom Inventory (CASI-4R) Generalized anxiety score (male (40-101); female (41-96) -where lower score= positive response) from Baseline to Week 12
Outcome measures
| Measure |
Intranasal Oxytocin
n=25 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=29 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Anxiety
|
-4.45 units on a scale
Interval -6.72 to -2.19
|
-2.30 units on a scale
Interval -5.45 to 0.85
|
SECONDARY outcome
Timeframe: 12 WeeksThis will be measured by improvement on the Pediatric Quality of Life Inventory (PedsQL) (0-100, where higher scores indicate positive response) from Baseline to Week 12
Outcome measures
| Measure |
Intranasal Oxytocin
n=25 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=29 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life
PedsQL Emotional Functioning
|
20.60 score on a scale
Interval 12.8 to 28.3
|
11.50 score on a scale
Interval 3.4 to 19.6
|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life
PedsQL Social Functioning
|
16.90 score on a scale
Interval 5.7 to 28.1
|
10.60 score on a scale
Interval 0.0 to 21.1
|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life
PedsQL School Functioning
|
11.1 score on a scale
Interval 2.2 to 20.0
|
8.1 score on a scale
Interval 0.3 to 15.9
|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life
PedsQL Health Summary
|
10.1 score on a scale
Interval 1.6 to 18.5
|
3.7 score on a scale
Interval -7.3 to 14.6
|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life
PedsQL Psychosocial
|
16.1 score on a scale
Interval 8.7 to 23.4
|
9.8 score on a scale
Interval 2.1 to 17.4
|
|
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life
PedsQL Total
|
14.2 score on a scale
Interval 7.0 to 21.4
|
7.6 score on a scale
Interval -0.5 to 15.6
|
SECONDARY outcome
Timeframe: 12 WeeksThis will be measured by the Clinical Global Impressions - Improvement Scale - Global (CGI-I-Global) (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as an overall responder (achieving a score of 1 or 2 on the scale).
Outcome measures
| Measure |
Intranasal Oxytocin
n=25 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=29 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Number of Participant Considered Overall Responders
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Of the original 60 participants enrolled at baseline, 6 participants dropped from the study, and none experienced SAEs
This will be measured by the Safety Monitoring Uniform Report Form (SMURF)
Outcome measures
| Measure |
Intranasal Oxytocin
n=30 Participants
Changes from baseline to week 12 on the ABC- Social Withdrawal
|
Placebo
n=30 Participants
Changes from baseline to week 24 on the ABC- Social Withdrawal
|
|---|---|---|
|
Safety and Tolerability of Intranasal Oxytocin in Children and Adolescents With ASD
Drop-outs
|
5 Participants
|
1 Participants
|
|
Safety and Tolerability of Intranasal Oxytocin in Children and Adolescents With ASD
SAEs
|
0 Participants
|
0 Participants
|
Adverse Events
Intranasal Oxytocin (Syntocinon)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Oxytocin (Syntocinon)
n=30 participants at risk
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Intranasal Oxytocin
|
Placebo
n=30 participants at risk
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/30
|
3.3%
1/30
|
|
Cardiac disorders
Palpitations
|
3.3%
1/30
|
0.00%
0/30
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/30
|
3.3%
1/30
|
|
Ear and labyrinth disorders
Ear discomfort
|
3.3%
1/30
|
0.00%
0/30
|
|
Ear and labyrinth disorders
Ear pain
|
3.3%
1/30
|
0.00%
0/30
|
|
Ear and labyrinth disorders
Hypoacusis
|
3.3%
1/30
|
0.00%
0/30
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/30
|
3.3%
1/30
|
|
Eye disorders
Diplopa
|
3.3%
1/30
|
0.00%
0/30
|
|
Eye disorders
Eye irritation
|
0.00%
0/30
|
3.3%
1/30
|
|
Eye disorders
Eye pain
|
0.00%
0/30
|
3.3%
1/30
|
|
Eye disorders
Eyelid thickening
|
0.00%
0/30
|
3.3%
1/30
|
|
Eye disorders
Myopia
|
6.7%
2/30
|
0.00%
0/30
|
|
Eye disorders
Vision blurred
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.3%
1/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30
|
10.0%
3/30
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Dental caries
|
3.3%
1/30
|
0.00%
0/30
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
2/30
|
10.0%
3/30
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/30
|
3.3%
1/30
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30
|
10.0%
3/30
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30
|
13.3%
4/30
|
|
General disorders
Chest pain
|
6.7%
2/30
|
3.3%
1/30
|
|
General disorders
Decreased activity
|
3.3%
1/30
|
0.00%
0/30
|
|
General disorders
Energy increased
|
3.3%
1/30
|
0.00%
0/30
|
|
General disorders
Fatigue
|
6.7%
2/30
|
16.7%
5/30
|
|
General disorders
Feeling hot
|
0.00%
0/30
|
3.3%
1/30
|
|
General disorders
Medical device complication
|
3.3%
1/30
|
0.00%
0/30
|
|
General disorders
Pain
|
0.00%
0/30
|
6.7%
2/30
|
|
General disorders
Pyrexia
|
3.3%
1/30
|
6.7%
2/30
|
|
Immune system disorders
Hypersensitivity
|
3.3%
1/30
|
0.00%
0/30
|
|
Immune system disorders
Multiple allergies
|
3.3%
1/30
|
3.3%
1/30
|
|
Infections and infestations
Cellulitis
|
0.00%
0/30
|
3.3%
1/30
|
|
Immune system disorders
Conjunctivitis infective
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Ear infection
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Gastrointestinal viral infection
|
3.3%
1/30
|
6.7%
2/30
|
|
Infections and infestations
Infected bites
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Influenza
|
6.7%
2/30
|
0.00%
0/30
|
|
Infections and infestations
Lice infestation
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Otitis media
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Pharyngitis
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/30
|
6.7%
2/30
|
|
Infections and infestations
Staphylcoccal skin infection
|
0.00%
0/30
|
3.3%
1/30
|
|
Infections and infestations
Upper respiratory tract infection
|
43.3%
13/30
|
23.3%
7/30
|
|
Infections and infestations
Viral infection
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/30
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
3.3%
1/30
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/30
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/30
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Injury
|
3.3%
1/30
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.3%
1/30
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/30
|
3.3%
1/30
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
3.3%
1/30
|
0.00%
0/30
|
|
Infections and infestations
Tendon injury
|
0.00%
0/30
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/30
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
2/30
|
6.7%
2/30
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/30
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
2/30
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/30
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
1/30
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30
|
3.3%
1/30
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/30
|
3.3%
1/30
|
|
Nervous system disorders
Disturbance in attention
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30
|
13.3%
4/30
|
|
Nervous system disorders
Headache
|
6.7%
2/30
|
16.7%
5/30
|
|
Nervous system disorders
Loss of consciousness
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Sedation
|
3.3%
1/30
|
0.00%
0/30
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/30
|
3.3%
1/30
|
|
Nervous system disorders
Sleep paralysis
|
0.00%
0/30
|
3.3%
1/30
|
|
Psychiatric disorders
Abnormal dreams
|
3.3%
1/30
|
0.00%
0/30
|
|
Psychiatric disorders
Affect liability
|
0.00%
0/30
|
3.3%
1/30
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30
|
3.3%
1/30
|
|
Psychiatric disorders
Attention-seeking behaviour
|
3.3%
1/30
|
0.00%
0/30
|
|
Psychiatric disorders
Coonfusional state
|
0.00%
0/30
|
3.3%
1/30
|
|
Psychiatric disorders
Depressed mood
|
3.3%
1/30
|
0.00%
0/30
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/30
|
3.3%
1/30
|
|
Psychiatric disorders
Initial insomnia
|
13.3%
4/30
|
6.7%
2/30
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/30
|
3.3%
1/30
|
|
Psychiatric disorders
Irritability
|
0.00%
0/30
|
13.3%
4/30
|
|
Psychiatric disorders
Middle insomnia
|
3.3%
1/30
|
6.7%
2/30
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/30
|
3.3%
1/30
|
|
Psychiatric disorders
Mood swings
|
3.3%
1/30
|
3.3%
1/30
|
|
Psychiatric disorders
Paranoia
|
3.3%
1/30
|
0.00%
0/30
|
|
Psychiatric disorders
Self injurious behaviour
|
0.00%
0/30
|
3.3%
1/30
|
|
Psychiatric disorders
Social avoidant behaviour
|
0.00%
0/30
|
3.3%
1/30
|
|
Psychiatric disorders
Terminal insomnia
|
6.7%
2/30
|
6.7%
2/30
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.3%
7/30
|
13.3%
4/30
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
5/30
|
23.3%
7/30
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
3.3%
1/30
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.3%
4/30
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Dyskinesia
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/30
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
1/30
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.3%
1/30
|
6.7%
2/30
|
|
Vascular disorders
Flushing
|
3.3%
1/30
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
2/30
|
10.0%
3/30
|
|
Metabolism and nutrition disorders
Hyperphagia
|
3.3%
1/30
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Increased appetite
|
13.3%
4/30
|
3.3%
1/30
|
|
Reproductive system and breast disorders
Breast swelling
|
3.3%
1/30
|
3.3%
1/30
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/30
|
3.3%
1/30
|
Additional Information
Lisa Genore
Holland Bloorview Kids Rehabilitation Hospital
Phone: 416-425-6220
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place