Intranasal oxytocin in youth with autism

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Psychological Phenomena [F02], Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

Decision date (initial)

2024-10-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-512387-56-00

EudraCT number

2021-006531-26

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on social behavior and repetitive behavior.

Secondary objectives 4

1. The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on behavioral inflexibility.
2. The effect of a single intranasal administration of 24 IU oxytocin delivered intranasally on performance on a computerized Emotional body language task, to index social cognition.
3. The effect of a single intranasal administration of 24 IU oxytocin delivered intranasally on performance on a computerized probabilistic reversal learning task, to index reversal learning.
4. The effect of a single intranasal administration of 24 IU oxytocin delivered intranasally on parasympathetic nervous system activity, as measured by heart rate variability.

Conditions and MedDRA coding

Autism spectrum disorder

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male and female participant between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) using the Autism Diagnostic Observation Schedule (ADOS).
2. Participants must be in good general physical health, as determined by the investigator.
3. Participants 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.
4. Provision of a signed, written informed consent, if 16 years and older. Participants between the ages of 12 and 15 (inclusive) will provide assent, with caregivers providing consent. Caregivers will also provide consent for research participation.

Exclusion criteria 12

1. Previous nasal disease, surgery, and dependence on inhaled drugs.
2. Current significant nasal congestion due to common colds.
3. Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
4. Systemic illness requiring treatment within 2 weeks prior to Study Day 1.
5. Full scale IQ < 70 (due to the prerequisite ability to complete self-report measures).
6. 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.
7. Known allergic reactions or hypersensitivity/intolerance to latex.
8. Currently breastfeeding.
9. Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at Experimental session 1 and 3 for all menstruating females).
10. Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.
11. New concomitant medications or formal cognitive/behavioral therapies. If a participant has been taking any medications or receiving formal cognitive/behavioral therapies for at least 4 weeks, then this is not considered a new therapy.
12. Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrollment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on social behavior. This will be operationalized as change from baseline on performance on the Social Responsiveness Scale-Second Edition (SRS-2), completed by caregivers of the participants.
2. The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on repetitive behavior. This will be operationalized as change from baseline on performance on the Repetitive Behavior Scale-Revised (RBS-R) scale, completed by caregivers of the participants.

Secondary endpoints 1

1. The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on behavioral inflexibility. This will be operationalized as change from baseline on performance on the Behavioral Inflexibility scale (BIS), completed by caregivers of the research participants

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Daniel S. Quintana

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Terje Nærland

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications