Autism Spectrum DisorderPhase 1/2NCT02414503
Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder
A Phase 1/2 study testing 8IU intranasal oxytocin, 24IU intranasal oxytocin and OptiNose Breath Powered Bi in people with Autism Spectrum Disorder, run by OptiNose AS at 1 site in Norway.
Trial summary
Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women. The intranasal administration of OT has recently attracted attention as a potential novel treatment in several psychiatric disorders in autism. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- 8IU intranasal oxytocin, 24IU intranasal oxytocin and OptiNose Breath Powered Bi
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2015to Feb 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects between the ages of 18 and 35, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis.
- Subjects must be in good general health, as determined by the investigator.
- Subject's pre-study physical examination, vital signs and electrocardiogram (ECG) must not show any clinically significant abnormalities as determined by the investigator.
- Subjects must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information
- Provision of a signed, written informed consent.
Who cannot join
- Subjects showing major septal deviation or a significantly altered nasal epithelium.
- Subjects with evidence of previous nasal disease, surgery, and dependence on inhaled drugs.
- Subjects with current significant nasal congestion due to common colds.
- Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
- Psychiatric co-morbidity that requires intervention (e.g., psychosis spectrum disorders, suicide intent)
- Systemic illness requiring treatment within 2 weeks prior to Study Day 1.
Show all 12Show fewer
- History of significant drug or alcohol abuse (as per WHO Alcohol use disorder identification test and drug use disorder identification test criteria) Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study.
- Abnormal laboratory values which is deemed clinically significant by investigator.
- Full scale IQ < 75 (due to the prerequisite ability to complete self report measures).
- Known allergic reactions or hypersensitivity to any component of the study medication in the nasal spray, such as propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) and chlorobutanol hemihydrate.
- Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.
- Other unspecified reasons that, in the opinion of the investigator or the sponsor make the subject unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
Norway1 site
NORMENT, KG Jebsen Centre for Psychosis Research - TOP Study
Oslo, 0424
About this study
Official title: A Randomized, Placebo Controlled, Double-blind, 3-period Cross-over Study in Adult Patients With Autism Spectrum Disorders Evaluating Cognitive Response After Single- Dose Oxytocin 8 or 24 IU Intranasal Administration Using the OptiNose Bi-directional Nose-to-brain Device
Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women. The intranasal administration of OT has recently attracted attention as a potential novel treatment in several psychiatric disorders in autism. However, given the anatomy of the nasal cavity, the current design of nasal sprays would be expected to provide an inadequate delivery of medication to the areas of the nasal cavity where direct transport into the brain via the olfactory nerve could potentially occur. OptiNose has developed an intranasal delivery device that provides improved reproducibility of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity where the olfactory nerve innervates the nasal cavity.
The primary objective of this study is to identify any differences between a single dose of 8 international units (IU) oxytocin, 24 IU oxytocin, and placebo delivered intranasally with the optimised OptiNose device in volunteers with Autism Spectrum Disorder. This will be measured in terms of performance on cognitive tests and physiological markers.
- Conditions
- Autism Spectrum Disorder
- Being tested
- 8IU intranasal oxytocin, 24IU intranasal oxytocin, Placebo, OptiNose Breath Powered Bi
- Keywords
- oxytocin, social cognition
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8IU intranasal oxytocinDrug
24IU intranasal oxytocinDrug
PlaceboDrug
OptiNose Breath Powered BiDevice
| Study group | Role | What they receive |
|---|---|---|
| 8IU intranasal oxytocin | Active comparator | 8IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device Receives: Drug: 8IU intranasal oxytocin; Device: OptiNose Breath Powered Bi |
| 24IU intranasal oxytocin | Active comparator | 24IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device Receives: Drug: 24IU intranasal oxytocin; Device: OptiNose Breath Powered Bi |
| Placebo | Placebo comparator | Placebo delivered with the OptiNose Breath Powered Bi directional liquid device Receives: Drug: Placebo; Device: OptiNose Breath Powered Bi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on an emotion sensitivity test
Participants will complete a task evaluating emotional expressions. These stimuli are identical to those published previously by Leknes et al., (2012).
Measured: 45 mins after oxytocin/placebo administration
Performance on a facial emotion morphing task
Participants will complete a task evaluating faces that morph into different emotional expressions.
Measured: 45 mins after oxytocin/placebo administration
Secondary outcomes (4)
Performance on the reading the mind in the eyes test
Participants will complete the reading the mind in the eyes test
Measured: 45 mins after oxytocin/placebo administration
Performance on an emotional dot probe task
Participants will complete an emotional dot probe task
Measured: 45 mins after oxytocin/placebo administration
Heart rate variability
Electrocardiogram data will be collected to assess heart rate variability, a measure of cardiac autonomic function.
Measured: 40 minutes after oxytocin/placebo administration
Eyetracking
An eyetracking device will measure eyegaze and pupillometry.
Measured: 45 mins after oxytocin/placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- OptiNose AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Ole A Andreassen, MD, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414503
- Sponsor's protocol ID
- SMR-2728
- Other IDs
- 2014-005452-26, 2014
- Status last verified
- Sep 2016
- First submitted
- 31 Mar 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Leknes S, Wessberg J, Ellingsen DM, Chelnokova O, Olausson H, Laeng B. Oxytocin enhances pupil dilation and sensitivity to 'hidden' emotional expressions. Soc Cogn Affect Neurosci. 2013 Oct;8(7):741-9. doi: 10.1093/scan/nss062. Epub 2012 May 29.
PubMed 22648957
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Double-blind, 3-period Cross-over Study in Adult Patients With Autism Spectrum Disorders Evaluating Cognitive Response After Single- Dose Oxytocin 8 or 24 IU Intranasal Administration Using the OptiNose Bi-directional Nose-to-brain Device
- ClinicalTrials.gov ID
- NCT02414503
- Acronym / sponsor ID
- SMR-2728
- Conditions
- Autism Spectrum Disorder
- Keywords
- oxytocin, social cognition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- OptiNose ASIndustry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital, University of Oslo
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women. The intranasal administration of OT has recently attracted attention as a potential novel treatment in several psychiatric disorders in autism. However, given the anatomy of the nasal cavity, the current design of nasal sprays would be expected to provide an inadequate delivery of medication to the areas of the nasal cavity where direct transport into the brain via the olfactory nerve could potentially occur. OptiNose has developed an intranasal delivery device that provides improved reproducibility of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity where the olfactory nerve innervates the nasal cavity.
The primary objective of this study is to identify any differences between a single dose of 8 international units (IU) oxytocin, 24 IU oxytocin, and placebo delivered intranasally with the optimised OptiNose device in volunteers with Autism Spectrum Disorder. This will be measured in terms of performance on cognitive tests and physiological markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 8IU intranasal oxytocin | Active comparator | Drug: 8IU intranasal oxytocin, Device: OptiNose Breath Powered Bi8IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device |
| 24IU intranasal oxytocin | Active comparator | Drug: 24IU intranasal oxytocin, Device: OptiNose Breath Powered Bi24IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device |
| Placebo | Placebo comparator | Drug: Placebo, Device: OptiNose Breath Powered BiPlacebo delivered with the OptiNose Breath Powered Bi directional liquid device |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects between the ages of 18 and 35, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis.
- Subjects must be in good general health, as determined by the investigator.
- Subject's pre-study physical examination, vital signs and electrocardiogram (ECG) must not show any clinically significant abnormalities as determined by the investigator.
- Subjects must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information
- Provision of a signed, written informed consent.
Key exclusion criteria (12 listed)
- Subjects showing major septal deviation or a significantly altered nasal epithelium.
- Subjects with evidence of previous nasal disease, surgery, and dependence on inhaled drugs.
- Subjects with current significant nasal congestion due to common colds.
- Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
- Psychiatric co-morbidity that requires intervention (e.g., psychosis spectrum disorders, suicide intent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8IU intranasal oxytocin | Drug | 8IU intranasal oxytocin |
| 24IU intranasal oxytocin | Drug | 24IU intranasal oxytocin |
| Placebo | Drug | Placebo |
| OptiNose Breath Powered Bi | Device | 24IU intranasal oxytocin, 8IU intranasal oxytocin, Placebo |
Primary outcome
Performance on an emotion sensitivity test
Time frame: 45 mins after oxytocin/placebo administration
Participants will complete a task evaluating emotional expressions. These stimuli are identical to those published previously by Leknes et al., (2012).
Performance on a facial emotion morphing task
Time frame: 45 mins after oxytocin/placebo administration
Participants will complete a task evaluating faces that morph into different emotional expressions.
4 secondary outcomes
Performance on the reading the mind in the eyes test
Time frame: 45 mins after oxytocin/placebo administration
Performance on an emotional dot probe task
Time frame: 45 mins after oxytocin/placebo administration
Heart rate variability
Time frame: 40 minutes after oxytocin/placebo administration
Eyetracking
Time frame: 45 mins after oxytocin/placebo administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Background: PubMed 22648957Leknes S, Wessberg J, Ellingsen DM, Chelnokova O, Olausson H, Laeng B. Oxytocin enhances pupil dilation and sensitivity to 'hidden' emotional expressions. Soc Cogn Affect Neurosci. 2013 Oct;8(7):741-9. doi: 10.1093/scan/nss062. Epub 2012 May 29.
- Norwegian Centre for Mental Disorders ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole A Andreassen, MD, PhD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 8IU intranasal oxytocin, 24IU intranasal oxytocin and OptiNose Breath Powered Bi in people with Autism Spectrum Disorder, run by OptiNose AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on an emotion sensitivity test (time frame: 45 mins after oxytocin/placebo administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.