Autism Spectrum DisorderPhase 2OT-DEFINCT05864508
Interest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study.
A Phase 2 study testing Oxytocin nasal spray in people with Autism Spectrum Disorder, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Minor benefiting from a social security scheme.
- Diagnosis:autism spectrum disorder according to the Diagnostic and Statistical Manual DSM -5 of severe intensity;
- Comorbidities:
- Moderate to severe intellectual disability
- Presence of challenging behavior objectified by means of clinical examination and the ABC and ABC-I scales
- Multi-professional psycho-educational and re-educational care : global and coordinated interventions associating, according to the needs, educational interventions by targeted objectives, therapeutic interventions involving functions that do not develop spontaneously, adaptation of the environment by structuring time and space, in close collaboration with the families.
Show all 9Show fewer
- If prescribed psychotropic treatments (antipsychotics, anxiolytics, hypnotics/sedatives, antidepressants, psychostimulants and antiepileptics), the dosages must be stable for 3 months*
- Understanding of French by both parents (if applicable) and ability for both parents to understand, in particular, the instructions for administering the product and to answer questionnaires.
- Informed consent signed by the holders of parental authority
Who cannot join
- The refusal of the holders of parental authority
- Pregnant girls, determined by a positive baseline blood pregnancy test
- Criteria respecting the Syntocinon SPC:
- Hypersensitivity to Syntocinon
- Hyponatremia < 135 mmol/L
- Hypokalaemia < 3.5 mmol/L
Show all 18Show fewer
- Hypertension or hypotension
- Behavioral intolerance to the intranasal route
- Hepatic impairment (ALT and/or AST > 3N)
- Kidney failure (creatinine > 3 N)
- History of an ECG considered to be clinically significant abnormal (validated by a cardiologist)
- Type 1 or 2 diabetes
- Prolongation of the QT interval and/or family history of QT prolongation linked to an identified genetic etiology (QTc prolongation threshold > 460 ms). **
- History of epilepsy or seizures
- Sexually active women of childbearing age without effective contraception*
- Breastfeeding women
- Severe cardiovascular disease (tachycardia, bradycardia, arrhythmias, hypertension, hypotension, myocardial ischemia)
- Latex allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexis REVET, MD, PhD contact
France1 site
Toulouse University hospital
Toulouse
Julie ANDANSON, MD, andanson.j@chu-toulouse.fr
Alexis REVET, MD, PHD, revet.a@chu-toulouse.fr
About this study
The investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior. In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.
Read the detailed description
Taking into account:
- Intellectual disability comorbidity as a risk factor for challenging behaviors in the population with autism spectrum disorder;
- behavioral difficulties inherent in the presence of these behaviors, which are all potential obstacles to the administration of a treatment and therefore above all raise the question of the feasibility of administering such a treatment;
- the difficulty for children associating autism spectrum disorder of severe intensity and intellectual disability to benefit from clinical and paraclinical examinations given the concern generated by such examinations and challenging behaviors which can then occur in them, raising the question of feasibility monitoring protocol
- results of Oxytocin administration obtained in patients with autism spectrum disorder without associated intellectual disability;
- the favorable drug safety profile of oxytocin in children with autism spectrum disorder of the same age but without challenging behaviors;
- the extreme need for an effective treatment to control challenging behaviors in children with autism spectrum disorder with associated intellectual disability, the investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior. In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Oxytocin nasal spray
- Keywords
- Autism Spectrum disorder, Oxytocin, Intellectual disability, Challenging behavior
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
intranasal oxytocin treatment once a day during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| intranasal oxytocin | Experimental | intranasal oxytocin treatment once a day during 6 weeks Receives: Drug: Oxytocin nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of children with complete OT administration protocol
percentage of children who will complete the OT administration protocol
Measured: Week 14
percentage of children with complete monitoring protocol
percentage of children who will complete the monitoring protocol
Measured: week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study startJul 2023 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie ANDANSON, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864508
- Sponsor's protocol ID
- RC31/19/0500
- Other IDs
- 2022-000254-28
- Acronym
- OT-DEFI
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study.
- ClinicalTrials.gov ID
- NCT05864508
- Acronym / sponsor ID
- OT-DEFI / RC31/19/0500
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum disorder, Oxytocin, Intellectual disability, Challenging behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 May 2023 (actual)
- 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.
The investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior. In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.
Detailed description
Taking into account:
- Intellectual disability comorbidity as a risk factor for challenging behaviors in the population with autism spectrum disorder;
- behavioral difficulties inherent in the presence of these behaviors, which are all potential obstacles to the administration of a treatment and therefore above all raise the question of the feasibility of administering such a treatment;
- the difficulty for children associating autism spectrum disorder of severe intensity and intellectual disability to benefit from clinical and paraclinical examinations given the concern generated by such examinations and challenging behaviors which can then occur in them, raising the question of feasibility monitoring protocol
- results of Oxytocin administration obtained in patients with autism spectrum disorder without associated intellectual disability;
- the favorable drug safety profile of oxytocin in children with autism spectrum disorder of the same age but without challenging behaviors;
- the extreme need for an effective treatment to control challenging behaviors in children with autism spectrum disorder with associated intellectual disability, the investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior. In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intranasal oxytocin | Experimental | Drug: Oxytocin nasal sprayintranasal oxytocin treatment once a day during 6 weeks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Minor benefiting from a social security scheme.
- Diagnosis:autism spectrum disorder according to the Diagnostic and Statistical Manual DSM -5 of severe intensity;
- Comorbidities:
- Moderate to severe intellectual disability
- Presence of challenging behavior objectified by means of clinical examination and the ABC and ABC-I scales
Key exclusion criteria (18 listed)
- The refusal of the holders of parental authority
- Pregnant girls, determined by a positive baseline blood pregnancy test
- Criteria respecting the Syntocinon SPC:
- Behavioral intolerance to the intranasal route
- Hepatic impairment (ALT and/or AST > 3N)
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 |
|---|---|---|
| Oxytocin nasal sprayintranasal oxytocin treatment once a day during 6 weeks | Drug | intranasal oxytocin |
Primary outcome
percentage of children with complete OT administration protocol
Time frame: Week 14
percentage of children who will complete the OT administration protocol
percentage of children with complete monitoring protocol
Time frame: week 14
percentage of children who will complete the monitoring protocol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Alexis REVET, MD, PhD contact
Julie ANDANSON, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin nasal spray in people with Autism Spectrum Disorder, run by University Hospital, Toulouse at 1 site in France.
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 9 inclusion and 18 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: opening soon, as of the sponsor's last update on 18 May 2023. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie ANDANSON, MD (05 61 77 80 75 ext. +33, andanson.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of children with complete OT administration protocol (time frame: Week 14). 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?
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 18 May 2023.