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    Summary
    EudraCT Number:2018-000769-35
    Sponsor's Protocol Code Number:S61358
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-07
    Trial results View 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 number2018-000769-35
    A.3Full title of the trial
    In search for an innovative neural marker and intervention for socio-communicative difficulties in children with and without autism spectrum disorders
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The use of Oxytocin for Autism Spectrum Disorders: Investigating the effect on behavior and at the level of the brain.
    A.3.2Name or abbreviated title of the trial where available
    MOX study - S61358
    A.4.1Sponsor's protocol code numberS61358
    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 SponsorUniversity Hospital, KU 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
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportSociety In Science - ETH Zurich
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital, KU Leuven
    B.5.2Functional name of contact pointProf. Dr. K. Alaerts
    B.5.3 Address:
    B.5.3.1Street AddressTervuursevest 101
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003216376446
    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 40 IE/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAlfasigma S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 RVG 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 codeS61358
    D.3.9.3Other descriptive nameOXYTOCIN
    D.3.9.4EV Substance CodeSUB09580MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    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 Disorders
    E.1.1.1Medical condition in easily understood language
    Autism Spectrum Disorders
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003808
    E.1.2Term Autistic disorder
    E.1.2System Organ Class 100000004873
    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 effects and mechanism of multiple-dose oxytocin treatment (OT) in children with Autism Spectrum Disorders (ASD) (age 8-12 years).

    The principal aim of the current clinical trial is to explore the effects and mechanism of multiple-dose OT treatment in children with ASD, by assessing the effects of treatment both at the neural and the behavioral level.
    E.2.2Secondary objectives of the trial
    A secondary objective of the trial is to explore the effects of multiple-dose OT treatment on physiological measurements of stress (e.g., heart rate variability, skin conductance, and respiration) and to identify mediating factors that may modulate treatment responses (e.g. symptom severity, OT concentration, epigenetic variations of the OT receptor gene).
    Furthermore, by adopting an extensive neuroimaging protocol (both EEG and MRI) and assessments of physiological measurements of stress (e.g., heart rate variability, skin conductance, and respiration), the current study will allow to specifically explore whether and how neural changes are related to changes in these physiological indices.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for inclusion in this Trial have to meet all of the following criteria:
    1. Written informed consent must be obtained prior to any screening procedures
    2. Male participants within an age-range of 8 to 12 years old ; only female participants at pre-puberty within this age-range at the onset of participation in the trial
    3. Stable background treatment during four weeks prior to screening

    Additionally, participants for the Trial Oxytocin treatment must meet the following criterium:
    1. Diagnosed with ASD by a multidisciplinary team of experienced clinicians as defined by the DSM-IV-TR or DSM- IV-TR criteria (Diagnostic and Statistical Manual of Mental Disorders).

    Note that 30 typically develloped (control) participants, with no diagnosis of ASD (age range 8-12 years) will be recruited to participate in the baseline assessments (no administration of oxytocin).
    E.4Principal exclusion criteria
    Patients eligible for this Trial must not meet any of the following criteria:
    1. Patient has history of any neurological disorder (stroke, concussion, epilepsy etc).
    2. Significant hearing or vision impairments.
    3. Non-Dutch native speaker.
    4. Verbal IQ below 70.
    5. Regular nasal obstruction or nosebleeds.
    6. Current or prior use of oxytocin.
    7. Participation in another Clinical Trial.
    8. Known hypersensitivity to active substance or excipients in nasal sprays.
    9. (Significant) change in background treatments.
    10. any contraindication to MRI research
    MRI contraindications
    pacemaker, implanted defibrillator, ear implant / a cochlear implant,
    insulin or implanted pump, a neurostimulator or VP shunt, any metallic
    object in the eyes (metallic fragments)

    E.5 End points
    E.5.1Primary end point(s)
    The primary aims of this project are assessing the change from baseline after oxytocin administration on:
    - Brain activity measured with Magnetic Resonance Imaging (MRI)
    (a) During tasks – Task based functional MRI: Eye Gaze and Fast Periodic Visual Stimulation Paradigm
    (b) During rest – Resting state functional MRI
    - Brain activity measured with Electro-encephalography (EEG)
    (a) During tasks – Task based EEG: Eye Gaze and Fast Periodic Visual Stimulation Paradigm
    (b) During rest – Resting state EEG
    - Behavioral assessments of autism symptoms (social functioning, repetitive behavior), (social) anxiety, attachment

    E.5.1.1Timepoint(s) of evaluation of this end point
    The end of the trial is anticipated September 2021.
    E.5.2Secondary end point(s)
    The secondary aims of this project are assessing the change from baseline after oxytocin administration on:
    - Physiological measurments
    Heart rate and heart rate variability
    Skin conductance
    Respiration
    - Endogene measurements of oxytocin and cortisol levels measured in saliva samples

    The clinical trial will also include two exploratory outcome measures:
    - additional saliva samples, to explore the level of epigenetic modifications of the oxytocin receptor gene
    - mouth swaps, to assess microbiome compositions
    - fecal samples, to assess microbiome compositions

    E.5.2.1Timepoint(s) of evaluation of this end point
    The end of the trial is anticipated September 2021.
    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
    Fundamental research to elucidate the effects and mechanism of multiple-dose oxytocin treatment at the neural (fMRI, EEG) and behavioral level and in terms of physiological indices of stress (heart rate, respiration, skin conductance), endogeneous oxytocin levels, epigenetic modifications of the oxytocin receptor gene and microbiome compositions.
    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 Yes
    E.8.1.7.1Other trial design description
    double blind, randomized, placebo-controlled trial with an single-blind extension trial
    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
    Last visit of the last participant
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 60
    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: 60
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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 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, four weeks after the treatment, there will be a final contact moment with each participant during which final behavioral and neurophysiological assessments will take place.

    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 Decision2018-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-30
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