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    Summary
    EudraCT Number:2022-002423-36
    Sponsor's Protocol Code Number:S66832
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-12-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2022-002423-36
    A.3Full title of the trial
    Evaluation of oxytocin treatment in children with autism and intellectual disability
    Onderzoek naar oxytocine therapie bij kinderen met autismespectrumstoornis en een verstandelijke beperking
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The use of oxytocin for Autism Spectrum Disorder with Intellectual Disability
    Het gebruik van Oxytocine neusspray bij kinderen met autismespectrumstoornis en een verstandelijke beperking
    A.3.2Name or abbreviated title of the trial where available
    MOX-AID
    A.4.1Sponsor's protocol code numberS66832
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKU Leuven
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportResearch Council KU Leuven (C2 project)
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportFlanders fund for scientific research (FWO-TBM project)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKU Leuven
    B.5.2Functional name of contact pointKaat Alaerts
    B.5.3 Address:
    B.5.3.1Street AddressTervuursevest 101
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3001
    B.5.3.4CountryBelgium
    B.5.6E-mailkaat.alaerts@kuleuven.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Syntocinon (oxytocin), nasal spray 40IE/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAlfasigma S.p.A. Via Ragazzi del ’99, n.5 40133 Bologna (BO) Italy
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSyntocinon (oxytocin)
    D.3.2Product code 03716
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxytocin
    D.3.9.1CAS number 50-56-6
    D.3.9.2Current sponsor codeS66832
    D.3.9.3Other descriptive nameOXYTOCIN
    D.3.9.4EV Substance CodeSUB09580MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typePharmaceutical
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autism Spectrum Disorder
    E.1.1.1Medical condition in easily understood language
    Autism Spectrum Disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067989
    E.1.2Term Intellectual disability
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063844
    E.1.2Term Autism spectrum disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Exploring the clinical effects and neurophysiological mechanisms of a four-week course of multiple-dose oxytocin treatment in children with Autism Spectrum Disorders with comorbid intellectual disability (age 4-13 years)
    A primary objective is to measure changes from baseline after oxytocin administration on:
    • Behavioral measurements of core autism symptoms
    • Cardio electrophysiological measurements of stress
    E.2.2Secondary objectives of the trial
    A secondary objective of the trial is to examine changes from baseline after oxytocin administration on:
    • Other behavioral outcomes (e.g. sleep quality, adaptive function)
    The clinical trial also includes exploratory outcome measures examining treatment-mechanistic aspects of the oxytocin treatment:
    • Oxytocin and cortisol hormonal levels
    • Other neurophysiological measurements of stress
    • Microbiome compositions
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants eligible for inclusion have to meet all of the following criteria:
    1. Children within an age-range of 4 to 13 years old with a clinical multidisciplinary diagnosis of ASD; only prepubertal girls will be included (girls with onset of menstruation during the course of the trial are allowed to continue the treatment).
    2. Children must be enrolled in a special need school, more specific a class comprising children with an intellectual disability or meet intellectual disability criteria; a total IQ below 75 and an ABAS score below 70.
    E.4Principal exclusion criteria
    Participants eligible for this Trial must not meet any of the following criteria:
    1. Patient takes anti-epileptic medication or has an active medical problems (e.g., serious liver, renal, or cardiac pathology) which influences the metabolism of oxytocin.
    2. Significant hearing or vision impairments.
    3. Subjects who have had previous chronic treatment with oxytocin
    4. Participation in another clinical trial with IMP.
    5. Known hypersensitivity to active substance or ingredients of the nasal spray
    6. Patient has a known syndrome that interacts with the reproductive hormonal system (e.g. Prader-Willi or Angelman syndrome)
    Although not a formal exclusion criterion, use of antibiotics within the last 3 months will be screened for, and if present, stool samples will not be collected from the participant.
    E.5 End points
    E.5.1Primary end point(s)
    The following clinical primary endpoints are specified:
    Assessment of changes from baseline after oxytocin administration on core autism symptoms using:
    - The Brief Observation of Social Communication Change (BOSCC) (clinician-rated).
    - The Autism Treatment Evaluation Checklist (ATEC) (parent (caregiver) and teacher-rated)

    Also, the following primary electrophysiological endpoint is specified:
    Assessment of changes from baseline after oxytocin treatment on electrocardiography (ECG) recordings for the assessment of heart rate variability (HRV) during rest and during social stimulation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The ATEC will be acquired from the parents (caregivers) at four time points: at baseline (T0), immediately after the four-week treatment (T1), and at the follow-up sessions four weeks (T2) and six months post-treatment (T3). The BOSCC will be taken by the clinicians at three time points: at baseline (T0), immediately after the four-week treatment (T1) and at the first follow-up session; four weeks after the treatment (T2).
    Teachers will fill in the ATEC at three time points: at baseline (T0), immediately after the four-week treatment (T1), and at the four-week follow-up session (T2).
    The ECG recordings will be acquired at four time points: at baseline (T0), immediately after the four-week treatment (T1), and at the follow-up sessions four weeks (T2).
    E.5.2Secondary end point(s)
    The following clinical secondary endpoints are specified:
    - The Adaptive Behavior Assessment System (ABAS-3) (parent (caregiver)-rated)
    - The Developmental Behaviour Checklist (DBC) (Flemish version: Vragenlijst over Ontwikkeling en Gedrag, VOG) (parent (caregiver)-rated)
    - The Perceived Stress Scale (PSS) (parent (caregiver)-rated)
    - The Child Sleep Hygiene Questionnaire (CSHQ) (parent (caregiver)-rated)
    - The Repetitive Behavior Scale - Revised (RBS-R) (parent (caregiver)-rated)

    Additionally, the trial will also encompass several treatment-mechanistic exploratory outcomes as specified in section E.6.13.1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The DBC will be assessed from the parents at baseline (T0), and one time as outcome assessment, namely at T3, the 6-month follow-up session. The ABAS will be assessed at the intake.
    The PSS, CSHQ and RBS-R will be assessed from the parents at four time points: at baseline (T0), immediately after the four-week treatment (T1), and at the follow-up sessions four weeks (T2) and six months post-treatment (T3).
    Teachers will complete the RBS-R at three time points: at baseline (T0), immediately after the four-week treatment (T1) and at the four weeks follow up (T2).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Next to the efficacy assessment, the trial encompasses the effects of multiple-dose oxytocin on neurophysiological and biological indices.
    The trial will also include exploratory outcome measures:
    1. Oxytocin-induced changes in autonomic nervous system stress neurophysiology (EEG, skin conductance, respiration, ambulant ECG)
    2. Oxytocin-induced changes in eye tracking
    3. Oxytocin-induced changes in biological samples (oxytocin and cortisol hormonal levels; mouth and gut microbiome).
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS: Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 80
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 80
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors, aged 6-13 years, with ASD and intellectual disability
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The end of the trial will be the last visit of the last participant. No specific treatment or care is required after the participant has ended his/her participation in the trial. However, as part of the protocol, 6 months after the treatment, there will be a final contact moment with each participant during which questionnaires and biological samples will be taken.
    Participants will be offered to have results and study outcome to be communicated to them.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-30
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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