Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
140
Countries
1
Sites
1
Autism Spectrum Disorder (ASD)
The primary objective of this project is to determine the change from baseline treatment effects on dyadic attunement between children with autism spectrum disorder and the experimenter
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Pediatric, Patients, Healthy volunteers
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04], Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01], Psychiatry and Psychology [F] - Psychological Phenomena [F02]
- Trial duration
- 18 Jun 2024 → ongoing
- Decision date (initial)
- 2024-03-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Apotheek A15 B.V. · Fonds voor Wetenschappelijk Onderzoek - Vlaanderen
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary objective of this project is to determine the change from baseline treatment effects on dyadic attunement between children with autism spectrum disorder and the experimenter
Conditions and MedDRA coding
Autism Spectrum Disorder (ASD)
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-505253-41-00 | Enhancing social attunement in autism via interpersonal sensorimotor synchronization therapy combined with single-dose intranasal oxytocin administration | UZ Leuven |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Voluntary written informed asent of the participant if possible and voluntary informed consent of their legally authorized representative has been obtained prior to any screening procedures
- Participants participating in the ASD group must have a formal ASD diagnosis, established by a multidisciplinary team of experienced clinicians as defined by the DSM-IV-TR or DSM-5- criteria (Diagnostic and Statistical Manual of Mental Disorders)
- Male participants within an age-range of 8 to 12 years old; only female participants at pre-puberty within this age-range on the day of the study visit
- Estimated Verbal Comprehension Index and Visiual Spatial Index determined by the WISC-V-NL above 70
- Psychopharmacological medication and psychosocial therapy must remain stable during four weeks prior to the intake visit and during four weeks prior to the study visit
Exclusion criteria 10
- Known hypersensitivity to active substance or excipients in nasal sprays
- Participants participating in the NT group must not have a total SRS T-score of ≥ 60
- Any active medical condition (neurological, psychiatric, developmental, gastrointestinal, motoric disorders, etc., other than ASD or comorbid ADHD in participants with ASD) that may affect the safety of the participant, the integrity of the trial, or the effect of the IMP.
- Any anti-epileptic medication and/or any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Significant hearing or vision impairments
- Non-Dutch native speaker
- Regular nasal obstruction or nosebleeds
- Subjects who recently have had previous chronic treatment with oxytocin
- Participants participating in the NT group or their first-degree relatives has a diagnosis of autism, and/or any psychiatric or neurological disorder that may affect the safety of the participant or the integrity of the trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint of this project is the change from baseline treatment effects on dyadic attunement in children with ASD and the experimenter, determined by multimodal measures of neurophysiological and behavioral responses as defined in the study protocol, during screen-based and real-life social interaction paradigms
Secondary endpoints 1
- The secondary endpoint of this project is the change from baseline treatment effects on post-intervention endogenous oxytocin and cortisol levels measured in saliva samples
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Syntocinon 40 IE/ml neusspray, oplossing
PRD5383601 · Product
- Active substance
- Oxytocin
- Substance synonyms
- GR121619
- Pharmaceutical form
- NASAL SPRAY, SOLUTION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 24 IU international unit(s)
- Max total dose
- 24 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01BB02 — OXYTOCIN
- Marketing authorisation
- RVG 03716
- MA holder
- ALFASIGMA S.P.A.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The pharmacy Apotheek A15 will repackage the Syntocinon into brown glass nasal spray bottles, which are identical to the ones used for the Placebo.
Placebo 1
Sodium Chloride Nasal Drops 0.9% (Fagron)
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- INTRANASAL USE
- Max daily dose
- 24 IU international unit(s)
- Max total dose
- 24 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The pharmacy Apotheek A15 will repackage the Sodium Chloride nasal drops 0.9% into brown glass nasal spray bottles, which are identical to the ones used for the IMP (Syntocinon).
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- Professor of the Study team
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Professor of the Study team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 140 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-06-18 | 2024-08-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 26 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-505253-41 | 6 |
| Protocol (for publication) | D4_Patient facing documents - Gehechtheid 3x3 | 1 |
| Protocol (for publication) | D4_Patient facing documents - Quality assessment of the conversation | 1.0 |
| Protocol (for publication) | D4_Patient facing documents - SCARED questionnaire | 1 |
| Protocol (for publication) | D4_Patient facing documents - Self-Assessment Manikin | 1.0 |
| Protocol (for publication) | D4_Patient facing documents - Social Responsiveness Scale A | 1.0 |
| Protocol (for publication) | D4_Patient facing documents - SRS_parent | 1.0 |
| Protocol (for publication) | D4_Patient facing documents - The Attachment Style Questionnaire ASQ | 1.0 |
| Protocol (for publication) | D4_Patient facing documents - The dyadic mirror game | 1.0 |
| Protocol (for publication) | D4_Patient facing documents - Wechsler Intelligence Scale for Children | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material Digital Poster | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material Digital Poster Vertical | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material Paper Poster | 2 |
| Subject information and informed consent form (for publication) | K1_Recruitment and Informed consent procedure | 3 |
| Subject information and informed consent form (for publication) | L1_Informationletter_ICF_Experimenter | 4.0 |
| Subject information and informed consent form (for publication) | L1_Informationletter_ICF_Minor_ASD | 3.0 |
| Subject information and informed consent form (for publication) | L1_Informationletter_ICF_Minor_NT | 3.0 |
| Subject information and informed consent form (for publication) | L1_Informationletter_ICF_Minor_Pilot | 2 |
| Subject information and informed consent form (for publication) | L1_Informationletter_ICF_Parent_ASD | 3.0 |
| Subject information and informed consent form (for publication) | L1_Informationletter_ICF_Parent_NT | 3.0 |
| Subject information and informed consent form (for publication) | L1_Informationletter_ICF_Parent_Pilot | 2 |
| Subject information and informed consent form (for publication) | L1_Informationletter_school-organisations | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_Smpc_oxytocin | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG-NL-FR-DU 2023-505253-41-00 | 4 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-05 | Belgium | Acceptable 2024-03-05
|
2024-03-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-27 | Belgium | Acceptable 2025-05-26
|
2025-05-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-03 | Belgium | Acceptable 2025-05-26
|
2025-12-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-13 | Belgium | Acceptable 2026-03-19
|
2026-03-19 |