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    Summary
    EudraCT Number:2013-003067-59
    Sponsor's Protocol Code Number:AOB/2013/01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-003067-59
    A.3Full title of the trial
    A single-center, randomized, double-blind, placebo-controlled, cross-over study of intranasal oxytocin in young adults with Autism Spectrum Disorder
    Studio monocentrico, cross-over, randomizzato, in doppio cieco, controllato con placebo, sulla somministrazione intranasale di ossitocina in giovani adulti con disturbi dello spettro autistico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oxytocin Trial
    Protocollo Ossitocina
    A.3.2Name or abbreviated title of the trial where available
    Oxytocin Study
    Studio Ossitocina
    A.4.1Sponsor's protocol code numberAOB/2013/01
    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 SponsorAZIENDA OSPEDALIERA G. BROTZU
    B.1.3.4CountryItaly
    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 supportFondazione Banco di Sardegna
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera G.Brotzu-Fase 1 srl
    B.5.2Functional name of contact pointUnit¿ di Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressPiazzale A. Ricchi 1
    B.5.3.2Town/ cityCagliari
    B.5.3.3Post code09134
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 070539301
    B.5.5Fax number+39 070539301
    B.5.6E-mailbalia@fase1.it
    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
    D.2.1.1.2Name of the Marketing Authorisation holderSigma Tau S.p.A. industrie Farmaceutiche Riunite
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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
    D.3.2Product code N.A.
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    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, solution
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autism Spectrum Disorder
    Disturbo dello Spettro Autistico
    E.1.1.1Medical condition in easily understood language
    Is a condition charaterized by abnormalities in the domains of communication and socialization and by a restricted and repetitive pattern of interests and activities.
    E' una condizione clinica caratterizzata da anomalie nei settori della comunicazione e della socializzazione e da attivit¿ ridotte e ripetitive.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003805
    E.1.2Term Autism
    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
    To evaluate the safety, the tolerability and the activity on social cognition of acute treatment of a single administration of IN-OXT versus placebo.
    Valutare la sicurezza, la tollerabilit¿ e l'attivit¿ sulla cognizione sociale del trattamento acuto di una singola somministrazione di IN-OXT rispetto al placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the activity of acute treatment of a single administration of IN-OXT versus placebo on social cognition, repetitive behaviour and anxiety in ASD.
    Valutare l'attivit¿ del trattamento acuto di una singola
    somministrazione di IN-OXT versus placebo sul comportamento ripetitivo e l' ansia in ASD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of Autism Spectrum Disorder.
    2. Participants aged 18-45 years of age inclusive. 3. Gender: male. 4. IQ = 70 as measured with the WAIS-IV. 5. Signed consent.
    6. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in Italian.
    7. Participant must be on a currently stable pharmacologic and/or psychoeducational treatments for at least 3 months and must not have made any treatment changes in the one month period prior to beginning this study.
    8. Normality or not clinically significant abnormality identified on the medical or laboratory evaluation at the screening visit. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
    9. Normality or not clinically significant abnormality vital Parameters (BP and HR included) at the screening visit.
    10. Normal or not clinically significant 12-lead ECG reading at the screening visit.
    1. Diagnosi di Disturbo dello Spettro Autistico.
    2. Partecipanti di età compresa tra 18-45 anni di età.
    3. Sesso: maschile.
    4. QI = 70 misurato con la WAIS-IV.
    5. Consenso informato.
    6. Possibilità di completare le attività: visione adeguata, controllo di una tastiera e mouse,
    italiano fluente.
    7. Il partecipante deve seguire un trattamento farmacologico stabile e / o trattamenti
    psicoeducativi per almeno 3 mesi e non deve aver fatto alcuna modifica di trattamento un
    mese prima di iniziare questo studio.
    8. Nessuna anomalia o anomalia non clinicamente significativa individuata durante la
    visita medica o rilevata tramite gli esami di laboratorio alla visita di screening. Un
    soggetto con un'anomalia o esami clinici di laboratorio con parametri al di fuori del range
    di riferimento per la propria fascia di età può essere incluso solo se il ricercatore ritiene
    che la sperimentazione non introdurrà ulteriori fattori di rischio e non interferisce con le
    procedure dello studio.
    9. Parametri vitali normali o non clinicamente significativi (inclusi BP e HR) alla visita di
    screening.
    10. ECG a 12 derivazioni normale o non clinicamente significativo alla visita di screening.
    E.4Principal exclusion criteria
    1. Gender: female.
    2. History of traumatic brain injury, epilepsy/seizure disorder (except febrile seizures), or other significant medical or genetic abnormality affecting brain function and motor, sensory or higher cognitive functioning.
    3. Patients with one or more of the following: HIV, HBV, HCV, recent nose and brain injuries, immunity disorder.
    4. Cardiac disorders (anamnesis, electrocardiogram, blood pressure and pulse): 50 = heart rate (bpm) = 90, 100 = blood pressure systolic (mmHg) = 140; 60 = blood pressure diastolic (mmHg) = 90.
    5. Sensory impairments (e.g., significant vision/hearing loss).
    6. Mental Retardation (e.g., IQ < 70, as measured with the WAIS-IV) or sensory-motor difficulties that would preclude valid use of diagnostic instruments.
    7. Anamnestic known hypersensitivity to oxytocin or to any of the excipients of Syntocinon Nasal spray. 8. Anamnestic known hypersensitivity to nasal sprays or other drugs.
    9. Fever or respiratory disease at the time of the baseline visit.
    10. Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues.
    11. Assumption of an investigational product within the following time period prior to the first dosing day in the current study: 6 months.
    12. Unwillingness or inability to follow the procedures outlined in the protocol.
    13. Use of inhalation anesthetics, e.g. cyclopropane or halotane within the following time period prior to the screening study day: one month. 14. Use of inhalation antibiotic(s) and inhalation anti-inflammatory drugs within the following time period prior to the screening study day: one month. 15. History of use of drugs of abuse and amphetamines.
    16. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units . One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
    17. Alcohol or nicotine (more than 15 cigarettes per day) abuse or dependence.
    18. Intake of food, coffee, beverages (except water), nicotine-consumption within the 2 hours before the application of oxytocin/placebo.
    1. Sesso: femminile.
    2. Storia di lesione traumatica cerebrale, disturbi epilettici / convulsioni (ad eccezione di
    convulsioni febbrili), o altra significativa anomalia medica o genetica che colpisce le
    funzioni cerebrali e motorie, il funzionamento cognitivo sensoriale o superiore.
    3. Pazienti con uno o più dei seguenti disturbi: HIV, HBV, HCV, recenti infortuni a naso ed
    encefalo, disturbi immunitari.
    4. Patologie cardiache (anamnesi, elettrocardiogramma, pressione sanguigna e
    pulsazioni): 50 = frequenza cardiaca (bpm) = 90, 100 = pressione arteriosa sistolica
    (mmHg) = 140; 60 = pressione arteriosa diastolica (mmHg) = 90.
    5. Menomazioni sensoriali (ad esempio, vista/ udito).
    6. Ritardo Mentale (ad esempio, QI <70, misurata con il WAIS-IV) o difficoltà sensorialimotorie
    che possano precludere l'uso degli strumenti diagnostici.
    7. Ipersensibilità nota a ossitocina o ad uno qualsiasi degli eccipienti di Syntocinon Spray
    nasale.
    8. Ipersensibilità nota anamnestica a spray nasali o altri farmaci.
    9. Febbre o malattia respiratoria al momento della visita basale.
    10. Giudizio del medico dello studio o del PI che il paziente non è adatto per lo studio a
    causa di problemi di sicurezza imprevedibili.
    11. Assunzione di un farmaco sperimentale nei 6 mesi precedenti l’assunzione del prodotto
    in studio.
    12. Riluttanza o incapacità di seguire le procedure indicate nel protocollo.
    13. Uso di anestetici per inalazione, ad esempio: ciclopropano o alotano nel mese
    precedente l’assunzione del prodotto in studio.
    14. Uso di farmaci antibiotici per inalazione e di farmaci anti infiammatori per inalazione
    nel mese precedente l’assunzione del prodotto in studio.
    15.Uso di droghe, anfetamine.
    16. Consumo regolare di alcool durante i 6 mesi dello studio definito come un apporto
    medio settimanale superiore a 21 unità o un apporto medio giornaliero superiore a 3
    unità. Una unità equivale a una mezza pinta (220 ml) di birra o 1 bicchierino (25 ml) di
    superalcolico o 1 bicchiere (125 ml) di vino.
    17. Abuso o dipendenza da nicotina (più di 15 sigarette al giorno).
    18. Assunzione di prodotti alimentari, caffè, bevande (eccetto acqua), nicotina entro le 2
    ore precedenti l'assunzione di ossitocina / placebo.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of IN-OXT in young adults with ASD.
    Sicurezza e tollerabilità di IN-OXT in giovani adulti con Disturbo dello Spettro Autistico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    About one month for each patient.
    Circa n.1 mese a paziente.
    E.5.2Secondary end point(s)
    Differences between IN-OXT and placebo condition (between 0 and max 80 minutes since the IN-OXT / placebo administration ) on direct observation of repetitive behaviors.
    Differenze tra IN-OXT e il placebo (tra 0 ed 80 minuti dalla somministrazione dell¿IN-OXT /placebo) sulle misure esatte della presenza e della frequenza di comportamenti ripetitivi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    About one month for each patient.
    CIrca n.1 mese a paziente.
    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 No
    E.6.4Safety Yes
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 patient will continue to receive all standard therapies expected for his condition with the proper care attention.
    Il paziente continuer¿ a ricevere tutte le terapie standard previste per la sua patologia con la dovuta attenzione assistenziale.
    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 Decision2016-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-25
    P. End of Trial
    P.End of Trial StatusOngoing
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