Clinical Trial Results:
Oxytocin-based pharmacotherapy for Autism Spectrum Disorders:
Investigating the neural and behavioral effects of a promising intervention
approach
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Summary
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EudraCT number |
2014-000586-45 |
Trial protocol |
BE |
Global end of trial date |
20 Dec 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Sep 2020
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First version publication date |
03 Sep 2020
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Other versions |
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Summary report(s) |
Summary (journal abstracts) |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
S56327
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02940574 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
KU Leuven
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Sponsor organisation address |
Tervuursevest 101, Leuven, Belgium, 3000
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Public contact |
Dr. K. Alaerts, KU Leuven, 0032 16376446, kaat.alaerts@kuleuven.be
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Scientific contact |
Dr. K. Alaerts, KU Leuven, 0032 16376446, kaat.alaerts@kuleuven.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Dec 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Dec 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Dec 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The current trial aims to explore the neural and behavioral effects of
oxytocin in autism spectrum disorders (ASD).
Initial studies showed that intranasal administration of oxytocin can
have a positive effect on social functioning in ASD. However, future
studies are necessary to explore whether and how oxytocin effects
neural processes in the brain underlying these behavioral improvements.
This trial will not only measure behavioral enhancements, but will
specifically focus on elucidating the associated neurophysiological
changes by guiding the administration of oxytocin with regular
neurophysiological assessments.
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Protection of trial subjects |
Regular screenings of potential side-effects
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Jun 2014
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Scientific research | ||
Long term follow-up duration |
1 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
40
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were mainly recruited from the Autism Expertise Centre at the Leuven University Hospital between April 2015 and December 2016. | |||||||||||||||
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Pre-assignment
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Screening details |
Assessed for eligibility (n= 68) Excluded (n = 28) Not meeting inclusion criteria (n= 3) Not interested to participate (n= 25) | |||||||||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||
Blinding implementation details |
Participants were randomly assigned to receive the oxytocin or placebo treatment based on a computer-generated randomized order. Except for the manager of randomization, all research staff conducting the study, participants, parents and partners were blind to treatment allocation.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Syntocinon (Oxytocin, Product Code RVG 03716) | |||||||||||||||
Arm description |
Administration via nasal spray Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Syntocinon (oxytocin), nasal spray 40 IE/ml
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Investigational medicinal product code |
RVG 03716
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Intranasal use
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Dosage and administration details |
A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray
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Arm title
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Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | |||||||||||||||
Arm description |
Administration via nasal spray Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Physiological water(sodium chloride (NaCl) 0.9 % solution)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Intranasal use
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Dosage and administration details |
Placebo (Physiological water (solution of sodium chloride (NaCl) in water))
Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray
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Baseline characteristics reporting groups
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Reporting group title |
Syntocinon (Oxytocin, Product Code RVG 03716)
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Reporting group description |
Administration via nasal spray Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))
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Reporting group description |
Administration via nasal spray Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Syntocinon (Oxytocin, Product Code RVG 03716)
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Reporting group description |
Administration via nasal spray Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray | ||
Reporting group title |
Placebo (Physiological Water(Sodium Chloride (NaCl) Solution))
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Reporting group description |
Administration via nasal spray Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray | ||
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End point title |
Change From Baseline in Brain Activity during task (Task-based fMRI) after a single dose of nasal spray [1] | ||||||||||||||||||
End point description |
Change From Baseline in Task-related Brain Activity during Biological Motion Recognition Task (Task-based fMRI) After a Single Dose of Nasal Spray
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End point type |
Primary
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End point timeframe |
Value at 30 minutes minus value at baseline
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attached chart/documents for results |
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| Notes [2] - n=1 not included, due to unusable data (excessive in-scanner head motion) |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from baseline in brain activity during task (task-based fMRI) after 4 weeks of nasal spray [3] | ||||||||||||||||||
End point description |
Change From Baseline in Task-related Brain Activity during Biological Motion Recognition Task (Task-based fMRI) after 4 weeks of nasal spray
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End point type |
Primary
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End point timeframe |
Value at 4 weeks minus value at baseline
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attached chart/documents for results |
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| Notes [4] - n=1 not included, due to unusable data (excessive in-scanner head motion) |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from baseline in brain activity during task (task-based fMRI) after 8 weeks, including 4 weeks without nasal spray [5] | ||||||||||||||||||
End point description |
Change From Baseline in Task-related Brain Activity during Biological Motion Recognition Task (Task-based fMRI) after 8 weeks, including 4 weeks without nasal spray
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End point type |
Primary
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End point timeframe |
Value at 8 weeks minus value at baseline
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attached chart/documents for results |
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| Notes [6] - n=1 not included, due to unusable data (excessive in-scanner head motion) |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from baseline in brain activity during task (task-based fMRI) after 52 weeks, including 48 weeks without nasal spray [7] | ||||||||||||||||||
End point description |
Change From Baseline in Task-related Brain Activity during Biological Motion Recognition Task (Task-based fMRI) after 52 weeks, including 48 weeks without nasal spray
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End point type |
Primary
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End point timeframe |
Value at 52 weeks minus value at baseline
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attached chart/documents for results |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from baseline in brain connectivity during rest (resting-state fMRI) after a single dose of nasal spray [8] | ||||||||||||
End point description |
Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray
Amygdala connectivity (Change-from-baseline z-transformed r-value)
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End point type |
Primary
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End point timeframe |
Value at 30 minutes minus value at baseline
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attached chart/documents for results |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline in brain connectivity during rest (resting-state fMRI) after 4 weeks of nasal spray [9] | ||||||||||||
End point description |
Change from baseline in brain connectivity during rest (resting-state fMRI) after 4 weeks of nasal spray
Amygdala connectivity (Change-from-baseline z-transformed r-value)
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End point type |
Primary
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End point timeframe |
Value at 4 weeks minus value at baseline
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attached chart/documents for results |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline in brain connectivity during rest (resting-state fMRI) after 8 weeks, including 4 weeks without nasal spray [10] | ||||||||||||
End point description |
Change from baseline in brain connectivity during rest (resting-state fMRI) after 8 weeks, including 4 weeks without nasal spray
Amygdala connectivity (Change-from-baseline z-transformed r-value)
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End point type |
Primary
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End point timeframe |
Value at 8 weeks minus value at baseline
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attached chart/documents for results |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline in brain connectivity during rest (resting-state fMRI) after 52 weeks, including 48 weeks without nasal spray [11] | ||||||||||||
End point description |
Change from baseline in brain connectivity during rest (resting-state fMRI) after 52 weeks, including 48 weeks without nasal spray
Amygdala connectivity (Change-from-baseline z-transformed r-value)
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End point type |
Primary
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End point timeframe |
Value at 52 weeks minus value at baseline
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| Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attached chart/documents for results |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline in performance on the emotion recognition task (accuracy/reaction time) after a single dose of nasal spray | ||||||||||||
End point description |
Change from baseline in performance on the emotion recognition task (accuracy/reaction time) after a single dose of nasal spray
Emotion recognition from point-light displays conveying biological motion.
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End point type |
Secondary
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End point timeframe |
Value at 30 minutes minus value at baseline
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 4 weeks of nasal spray | ||||||||||||
End point description |
Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 4 weeks of nasal spray.
Emotion recognition from point-light displays conveying biological motion.
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End point type |
Secondary
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End point timeframe |
Value at 4 weeks minus value at baseline
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 8 weeks (including 4 weeks without nasal spray) | ||||||||||||
End point description |
Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 8 weeks (including 4 weeks without nasal spray).
Emotion recognition from point-light displays conveying biological motion.
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End point type |
Secondary
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End point timeframe |
Value at 8 weeks minus value at baseline
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 52 weeks (including 48 weeks without nasal spray) | ||||||||||||
End point description |
Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 52 weeks (including 48 weeks without nasal spray)
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End point type |
Secondary
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End point timeframe |
Value at 52 weeks minus value at baseline
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from baseline in informant-based/ self-report scores on questionnaires assessing attachment, social functioning, quality of life and mood after 4 weeks of nasal spray | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness.
The Repetitive Behavior Scale – Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors.
The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale.
Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents.
World Health Organization Quality of Life – Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life.
Profile of Mood States (POMS). five-point Likert scale.
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End point type |
Secondary
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End point timeframe |
Value at 4 weeks minus value at baseline
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| Notes [12] - Intention-to-treat [13] - Intention-to-treat |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change from baseline in informant-based/ self-report scores on questionnaires assessing attachment, social functioning, quality of life and mood after 8 weeks, including 4 weeks without nasal spray | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness.
The Repetitive Behavior Scale – Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors.
The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale.
Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents.
World Health Organization Quality of Life – Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life.
Profile of Mood States (POMS). five-point Likert scale.
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End point type |
Secondary
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End point timeframe |
Value at 8 weeks minus value at baseline
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| Notes [14] - Intention-to-Treat [15] - Intention-to-Treat |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change from baseline in Informant-based/ Self-report scores on questionnaires assessing attachment, social functioning, quality of life and mood after 52 weeks, including 48 weeks without nasal spray | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness.
The Repetitive Behavior Scale – Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors.
The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale.
Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents.
World Health Organization Quality of Life – Bref (WHO-QOL) uses a five-point Likert scale. Higher scores indicate better quality of life.
Profile of Mood States (POMS). five-point Likert scale.
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End point type |
Secondary
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End point timeframe |
Value at 52 weeks minus value at baseline
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| Notes [16] - Intention-to-Treat [17] - Intention-to-Treat |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Adverse event data were collected over a period of (approximately) four weeks.
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Adverse event reporting additional description |
Adverse event data were collected via weekly journal entries. Participants were asked to indicate whether or not they had experienced any potential adverse events, when it started, how long it lasted, and the severity of the adverse event (mild, moderate, severe).
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Assessment type |
Systematic | |||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
Self-report | |||||||||||||||||||||
Dictionary version |
2014
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Reporting groups
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Reporting group title |
Syntocinon (Oxytocin, product code RVG 03716)
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Reporting group description |
Administration via nasal spray Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray | |||||||||||||||||||||
Reporting group title |
Placebo (Physiological water(sodium chloride (NaCl) solution))
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Reporting group description |
Administration via nasal spray Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray | |||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/32161366 http://www.ncbi.nlm.nih.gov/pubmed/31969977 |
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