OXY-R: Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD)

• Sponsor: Evdokia Anagnostou (Other)
• Overall Status: Completed
• CT.gov ID: NCT01908205
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 30
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon® has been approved by the U.S. Food and Drug Administration for use in helping women breastfeed, but it has not been approved for use in children with ASD. However, there is previous research conducted that has indicated that after administration of oxytocin, adults with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and anxiety. There is also early research to suggest that children may also benefit in these areas. The purpose of this study is to test if oxytocin works to help children and adolescents with ASD.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Drug: Intranasal Oxytocin; Drug: Placebo	Phase 2

Detailed Description

Extensive data has been accumulated to suggest that central release of oxytocin is important for social cognition and function, as well as likely involved in anxiety modulation and repetitive behaviors. The Principal Investigator and Co-Principal Investigator of this study have previously documented: 1) an association between ASD and a single nuclear polymorphism of the oxytocin receptor gene, 2) ability to measure oxytocin levels in the blood by enzyme immunoassay and 3) preliminary data to support safety and efficacy of intranasal oxytocin in the treatment of social deficits and repetitive behaviors in adults with autism. A medication treatment targeting the core deficits of ASD in childhood is highly valuable because it could influence the developmental trajectory and make further psychosocial interventions possible. In this context, we propose a randomized placebo controlled trial of intranasal oxytocin in children and adolescents with ASD.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intranasal Oxytocin (Syntocinon) The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose	Drug: Intranasal Oxytocin; Other Names: Syntocinon
Placebo Comparator: Placebo The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function [12 and 24 weeks]

   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)

Secondary Outcome Measures

1. Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition [12 Weeks]

   This 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

2. Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition [12 Weeks]

   This 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)

3. Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function [12 Weeks]

   This 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

4. Number of Participant Considered Social Responders [12 Weeks]

   This 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).

5. Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors [12 Weeks]

   This 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)

6. Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors [12 Weeks]

   This will be measured by improvement on the Repetitive Behavior Scale (RBS-R)(0-129; where lower score= positive response) from Baseline to Week 12

7. Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Anxiety [12 Weeks]

   This 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

8. Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life [12 Weeks]

   This 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

9. Number of Participant Considered Overall Responders [12 Weeks]

   This 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).

10. Safety and Tolerability of Intranasal Oxytocin in Children and Adolescents With ASD [12 Weeks]

    This will be measured by the Safety Monitoring Uniform Report Form (SMURF)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Male or female outpatients, 10-17 years of age inclusive.

2. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition. Diagnostic and Statistical Manual (DSM-IV) criteria will be established by a clinician with expertise with individuals with ASD. Best estimate Diagnosis will be reached using DSM-IV criteria, the Autism Diagnostic Observation Schedule (ADOS-2) and the Autism Diagnostic Interview (ADI-R).

3. Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Screening.

4. Verbal and performance scale Intelligence Quotient (IQ) ≥ 70 (both subtests of the Wechsler Abbreviated Scale of Intelligence (WASI-I or WASI-II ≥ 70).

5. If already receiving stable concomitant medications affecting behavior, have continuous participation for 1 month prior to Screening (with the exception of fluoxetine, where a period of 6 weeks is needed), and not electively initiate new or modify ongoing medications for the duration of the study.

6. If already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening, and not electively initiate new or modify ongoing interventions for the duration of the study.

7. Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed not clinically significant by the Treating Clinician.

8. Ability to speak and understand English sufficiently to allow for the completion of all study assessments.

9. Ability to obtain written informed consent from the participant, if developmentally appropriate. If a participant does not have the capacity to consent, ability to obtain assent (if developmentally appropriate), as well as written informed consent from their parent(s)/legal guardian.

Exclusion Criteria

1. Patients born prior to 35 weeks gestational age.

2. Patients with a primary psychiatric diagnosis other than ASD.

3. Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal brain MRI/structural lesion.

4. Pregnant female patients, sexually active female patients on hormonal birth control and sexually active females who do not use at least two types of non-hormonal birth control.

5. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease.

6. Patients with one or more of the following: HIV, Hepatitis B virus, Hepatitis C virus, hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder or severe depression.

7. Patients who are currently taking oxytocin or have taken intranasal oxytocin in the past with no response.

8. Patients with a sensitivity to oxytocin or any components of its formulation.

9. Patients unable to tolerate venipuncture procedures for blood sampling.

10. Patients in foster care for whom the province/state is defined as a legal guardian

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455
2	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario	Canada	M4G 1R8

Sponsors and Collaborators

• Evdokia Anagnostou
• United States Department of Defense

Investigators

• Principal Investigator: Evdokia Anagnostou, M.D., Holland Bloorview Kids Rehabilitation Hospital
• Principal Investigator: Suma Jacob, M.D., Ph.D., University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Evdokia Anagnostou, Principal Investigator, Anagnostou, Evdokia, M.D.
• ClinicalTrials.gov Identifier: NCT01908205
• Other Study ID Numbers: OXY-R07-2013
• First Posted: Jul 25, 2013
• Last Update Posted: Nov 16, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Evdokia Anagnostou, Principal Investigator, Anagnostou, Evdokia, M.D.: Autism; Social; Functioning; Cognition; Repetitive Behaviors; Anxiety; Quality of Life
• Additional relevant MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Oxytocin

Study Results

Participant Flow

Arm/Group Title	Intranasal Oxytocin (Syntocinon)	Placebo
Arm/Group Description	The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose Intranasal Oxytocin	The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose Placebo
Period Title: Overall Study
STARTED	30	30
COMPLETED	25	29
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	Intranasal Oxytocin (Syntocinon)	Placebo	Total
Arm/Group Description	The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose Intranasal Oxytocin	The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose Placebo	Total of all reporting groups
Overall Participants	25	29	54
Age (Count of Participants)
<=18 years	25 100%	29 100%	54 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	2 8%	5 17.2%	7 13%
Male	23 92%	24 82.8%	47 87%

Outcome Measures

1. Primary Outcome

Title	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
Description	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)
Time Frame	12 and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	Changes from baseline to week 12 on the ABC- Social Withdrawal	Changes from baseline to week 24 on the ABC- Social Withdrawal
Measure Participants	25	29
Baseline - Week 12	-2.43	-3.06
Baseline- Week 24	-1.34	-3.03

2. Secondary Outcome

Title	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
Description	This 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
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	To examine the effect of IN-OXT vs. placebo on the Revised Eyes test at week 12	To examine the effect of IN-OXT vs. placebo on the Revised Eyes test at week 12
Measure Participants	25	29
Mean (95% Confidence Interval) [score on a scale]	0.14	-0.29

3. Secondary Outcome

Title	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition
Description	This 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)
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	To examine the effect of IN-OXT vs. placebo on measures of social cognition	To examine the effect of IN-OXT vs. placebo on measures of social cognition
Measure Participants	25	29
Let's Face It Matchmaker	4.50	5.90
Let's Face It Faces	6.20	1.52
Let's Face It Houses	4.94	2.07

4. Secondary Outcome

Title	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
Description	This 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
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	To examine the effect of IN-OXT vs. placebo on measures of social function	To examine the effect of IN-OXT vs. placebo on measures of social cognition
Measure Participants	25	29
BASC-2 Social Skills	1.40	0.43
BASC-2 Withdrawal	-1.38	-1.74

5. Secondary Outcome

Title	Number of Participant Considered Social Responders
Description	This 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).
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	To examine the effect of IN-OXT vs. placebo on measures of social function	To examine the effect of IN-OXT vs. placebo on measures of social cognition
Measure Participants	29	25
Count of Participants [Participants]	6 24%	10 34.5%

6. Secondary Outcome

Title	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors
Description	This 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)
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	To examine the effect of IN-OXT vs. placebo on measures of repetitive behaviours	To examine the effect of IN-OXT vs. placebo on measures of repetitive behaviours
Measure Participants	25	29
Mean (95% Confidence Interval) [units on a scale]	-2.77	-2.99

7. Secondary Outcome

Title	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors
Description	This will be measured by improvement on the Repetitive Behavior Scale (RBS-R)(0-129; where lower score= positive response) from Baseline to Week 12
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	To examine the effect of IN-OXT vs. placebo on measures of repetitive behaviours	To examine the effect of IN-OXT vs. placebo on measures of social cognition
Measure Participants	25	29
Mean (95% Confidence Interval) [units on a scale]	-6.74	-4.62

8. Secondary Outcome

Title	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Anxiety
Description	This 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
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	To examine the effect of IN-OXT vs. placebo on measures of anxiety	To examine the effect of IN-OXT vs. placebo on measures of anxiety
Measure Participants	25	29
Mean (95% Confidence Interval) [units on a scale]	-4.45	-2.30

9. Secondary Outcome

Title	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life
Description	This 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
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	To examine the effect of IN-OXT vs. placebo on measures of quality of life	To examine the effect of IN-OXT vs. placebo on measures of quality of life
Measure Participants	25	29
PedsQL Emotional Functioning	20.60	11.50
PedsQL Social Functioning	16.90	10.60
PedsQL School Functioning	11.1	8.1
PedsQL Health Summary	10.1	3.7
PedsQL Psychosocial	16.1	9.8
PedsQL Total	14.2	7.6

10. Secondary Outcome

Title	Number of Participant Considered Overall Responders
Description	This 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).
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	To examine safety and tolerability of INOXT	To examine safety and tolerability of INOXT
Measure Participants	25	29
Count of Participants [Participants]	8 32%	8 27.6%

11. Secondary Outcome

Title	Safety and Tolerability of Intranasal Oxytocin in Children and Adolescents With ASD
Description	This will be measured by the Safety Monitoring Uniform Report Form (SMURF)
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

Of the original 60 participants enrolled at baseline, 6 participants dropped from the study, and none experienced SAEs

Arm/Group Title	Intranasal Oxytocin	Placebo
Arm/Group Description	To examine safety and tolerability of INOXT	To examine safety and tolerability of INOXT
Measure Participants	30	30
Drop-outs	5 20%	1 3.4%
SAEs	0 0%	0 0%

Adverse Events

Arm/Group Title	Intranasal Oxytocin (Syntocinon)		Placebo
Arm/Group Description	The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose Intranasal Oxytocin		The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose Placebo
All Cause Mortality
	Intranasal Oxytocin (Syntocinon)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Intranasal Oxytocin (Syntocinon)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Intranasal Oxytocin (Syntocinon)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/30 (93.3%)		25/30 (83.3%)
Blood and lymphatic system disorders
Lymphadenopathy	0/30 (0%)		1/30 (3.3%)
Cardiac disorders
Palpitations	1/30 (3.3%)		0/30 (0%)
Ear and labyrinth disorders
Ear congestion	0/30 (0%)		1/30 (3.3%)
Ear discomfort	1/30 (3.3%)		0/30 (0%)
Ear pain	1/30 (3.3%)		0/30 (0%)
Hypoacusis	1/30 (3.3%)		0/30 (0%)
Motion sickness	0/30 (0%)		1/30 (3.3%)
Eye disorders
Diplopa	1/30 (3.3%)		0/30 (0%)
Eye irritation	0/30 (0%)		1/30 (3.3%)
Eye pain	0/30 (0%)		1/30 (3.3%)
Eyelid thickening	0/30 (0%)		1/30 (3.3%)
Myopia	2/30 (6.7%)		0/30 (0%)
Vision blurred	0/30 (0%)		1/30 (3.3%)
Gastrointestinal disorders
Abdominal discomfort	1/30 (3.3%)		1/30 (3.3%)
Abdominal distension	1/30 (3.3%)		0/30 (0%)
Abdominal pain	1/30 (3.3%)		3/30 (10%)
Abdominal pain upper	0/30 (0%)		1/30 (3.3%)
Aphthous stomatitis	1/30 (3.3%)		0/30 (0%)
Dental caries	1/30 (3.3%)		0/30 (0%)
Diarrhoea	2/30 (6.7%)		3/30 (10%)
Dry mouth	0/30 (0%)		1/30 (3.3%)
Dyspepsia	0/30 (0%)		1/30 (3.3%)
Loose tooth	0/30 (0%)		1/30 (3.3%)
Nausea	0/30 (0%)		3/30 (10%)
Vomiting	0/30 (0%)		4/30 (13.3%)
General disorders
Chest pain	2/30 (6.7%)		1/30 (3.3%)
Decreased activity	1/30 (3.3%)		0/30 (0%)
Energy increased	1/30 (3.3%)		0/30 (0%)
Fatigue	2/30 (6.7%)		5/30 (16.7%)
Feeling hot	0/30 (0%)		1/30 (3.3%)
Medical device complication	1/30 (3.3%)		0/30 (0%)
Pain	0/30 (0%)		2/30 (6.7%)
Pyrexia	1/30 (3.3%)		2/30 (6.7%)
Immune system disorders
Hypersensitivity	1/30 (3.3%)		0/30 (0%)
Multiple allergies	1/30 (3.3%)		1/30 (3.3%)
Conjunctivitis infective	0/30 (0%)		1/30 (3.3%)
Infections and infestations
Cellulitis	0/30 (0%)		1/30 (3.3%)
Ear infection	1/30 (3.3%)		0/30 (0%)
Gastroenteritis	0/30 (0%)		1/30 (3.3%)
Gastrointestinal viral infection	1/30 (3.3%)		2/30 (6.7%)
Infected bites	1/30 (3.3%)		0/30 (0%)
Influenza	2/30 (6.7%)		0/30 (0%)
Lice infestation	1/30 (3.3%)		0/30 (0%)
Otitis media	0/30 (0%)		1/30 (3.3%)
Pharyngitis	1/30 (3.3%)		0/30 (0%)
Pharyngitis streptococcal	0/30 (0%)		2/30 (6.7%)
Staphylcoccal skin infection	0/30 (0%)		1/30 (3.3%)
Upper respiratory tract infection	13/30 (43.3%)		7/30 (23.3%)
Viral infection	1/30 (3.3%)		0/30 (0%)
Viral upper respiratory tract infection	0/30 (0%)		1/30 (3.3%)
Tendon injury	0/30 (0%)		1/30 (3.3%)
Injury, poisoning and procedural complications
Arthropod sting	1/30 (3.3%)		0/30 (0%)
Concussion	0/30 (0%)		1/30 (3.3%)
Fall	0/30 (0%)		1/30 (3.3%)
Injury	1/30 (3.3%)		1/30 (3.3%)
Joint injury	1/30 (3.3%)		0/30 (0%)
Ligament sprain	0/30 (0%)		1/30 (3.3%)
Spinal column injury	1/30 (3.3%)		0/30 (0%)
Metabolism and nutrition disorders
Decreased appetite	2/30 (6.7%)		3/30 (10%)
Hyperphagia	1/30 (3.3%)		0/30 (0%)
Increased appetite	4/30 (13.3%)		1/30 (3.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/30 (0%)		1/30 (3.3%)
Back pain	2/30 (6.7%)		2/30 (6.7%)
Medial tibial stress syndrome	0/30 (0%)		1/30 (3.3%)
Muscle spasms	2/30 (6.7%)		0/30 (0%)
Musculoskeletal pain	0/30 (0%)		1/30 (3.3%)
Myalgia	1/30 (3.3%)		0/30 (0%)
Pain in extremity	0/30 (0%)		1/30 (3.3%)
Pain in jaw	0/30 (0%)		1/30 (3.3%)
Nervous system disorders
Disturbance in attention	1/30 (3.3%)		0/30 (0%)
Dizziness	0/30 (0%)		4/30 (13.3%)
Headache	2/30 (6.7%)		5/30 (16.7%)
Loss of consciousness	1/30 (3.3%)		0/30 (0%)
Sedation	1/30 (3.3%)		0/30 (0%)
Sinus headache	0/30 (0%)		1/30 (3.3%)
Sleep paralysis	0/30 (0%)		1/30 (3.3%)
Psychiatric disorders
Abnormal dreams	1/30 (3.3%)		0/30 (0%)
Affect liability	0/30 (0%)		1/30 (3.3%)
Anxiety	3/30 (10%)		1/30 (3.3%)
Attention-seeking behaviour	1/30 (3.3%)		0/30 (0%)
Coonfusional state	0/30 (0%)		1/30 (3.3%)
Depressed mood	1/30 (3.3%)		0/30 (0%)
Euphoric mood	0/30 (0%)		1/30 (3.3%)
Initial insomnia	4/30 (13.3%)		2/30 (6.7%)
Insomnia	0/30 (0%)		1/30 (3.3%)
Irritability	0/30 (0%)		4/30 (13.3%)
Middle insomnia	1/30 (3.3%)		2/30 (6.7%)
Mood altered	0/30 (0%)		1/30 (3.3%)
Mood swings	1/30 (3.3%)		1/30 (3.3%)
Paranoia	1/30 (3.3%)		0/30 (0%)
Self injurious behaviour	0/30 (0%)		1/30 (3.3%)
Social avoidant behaviour	0/30 (0%)		1/30 (3.3%)
Terminal insomnia	2/30 (6.7%)		2/30 (6.7%)
Reproductive system and breast disorders
Breast swelling	1/30 (3.3%)		1/30 (3.3%)
Pruritus genital	0/30 (0%)		1/30 (3.3%)
Respiratory, thoracic and mediastinal disorders
Cough	2/30 (6.7%)		1/30 (3.3%)
Epistaxis	7/30 (23.3%)		4/30 (13.3%)
Nasal congestion	5/30 (16.7%)		7/30 (23.3%)
Nasal dryness	1/30 (3.3%)		0/30 (0%)
Oropharyngeal pain	4/30 (13.3%)		2/30 (6.7%)
Skin and subcutaneous tissue disorders
Acne	1/30 (3.3%)		0/30 (0%)
Dyskinesia	1/30 (3.3%)		0/30 (0%)
Ingrowing nail	0/30 (0%)		2/30 (6.7%)
Pruritus	1/30 (3.3%)		0/30 (0%)
Rash	1/30 (3.3%)		2/30 (6.7%)
Urticaria	1/30 (3.3%)		2/30 (6.7%)
Vascular disorders
Flushing	1/30 (3.3%)		0/30 (0%)

Limitations/Caveats

Limitations include a small sample size, age range restricted to 10-17, and IQ restriction of 70+. This limits our ability to generalize our results to other individuals on the autism spectrum.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.