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    Summary
    EudraCT Number:2018-000143-12
    Sponsor's Protocol Code Number:ORBIS-DE-UNIBO001
    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:2023-06-12
    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 number2018-000143-12
    A.3Full title of the trial
    OXYTOCIN RESEARCH FOR BEHAVIORAL IMPAIRMENT SYMPTOMS IN DEMENTIA: Potential clinical efficacy of intranasal oxytocin in the treatment of frontotemporal dementia. A randomized, double-blind, placebo-controlled crossover trial.
    OXYTOCIN RESEARCH FOR BEHAVIORAL IMPAIRMENT SYMPTOMS IN DEMENTIA: Potential clinical efficacy of intranasal oxytocin in the treatment of frontotemporal dementia. A randomized, double-blind, placebo-controlled crossover trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of intranala oxytocin in dementia. A randomized double-blind, placebo-controlled trial.
    Efficacia di ossitocina intranasale per la demenza. Uno studio randomizzato in doppio cieco controllato con placebo.
    A.3.2Name or abbreviated title of the trial where available
    ORBIS-DE-UNIBO001
    ORBIS-DE-UNIBO001
    A.4.1Sponsor's protocol code numberORBIS-DE-UNIBO001
    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 SponsorALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA
    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 supportAIFA - Italian Medicines Agency
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversità di Bologna
    B.5.2Functional name of contact pointDIMEC
    B.5.3 Address:
    B.5.3.1Street AddressVia Massarenti 9
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.6E-mailkatia.mattarozzi@unibo.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.2.1.2Country 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.3.4Pharmaceutical 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 INNOSSITOCINA
    D.3.9.2Current sponsor codeSyntocinon
    D.3.9.3Other descriptive nameSyntocinon
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    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) Yes
    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
    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
    Frontotemporal dementia (bvFTD)
    Demenza frontotemporale (bvFTD)
    E.1.1.1Medical condition in easily understood language
    Dementia
    Demenza
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10068968
    E.1.2Term Frontotemporal dementia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary goal is to investigate whether acute intranasal administration of oxytocin improves social cognition performances in bvFTD patients, as detected using experimental tasks.
    1. Change from placebo condition in emotion recognition ability [ Time Frame: within two hours after IMP-1/IMP-2 administration, single-measurement/treatment (total of observations: 2)]
    2. Change from placebo condition in empathy ability [ Time Frame: within two hours after IMP-1/IMP-2 administration, single-measurement/treatment (total of observations: 2)]
    3. Change from placebo condition in time perception [ Time Frame: within two hours after IMP-1/IMP-2 administration, each testing day (total of observations: 4)]
    Testare l’effetto dell’ossitocina in confronto a placebo sul:
    i) riconoscimento delle emozioni
    ii) riconoscimento delle intenzioni altrui
    iii) percezione del tempo durante interazioni sociali
    nel paziente con diagnosi di variante comportamentale di demenza frontotemporale.
    E.2.2Secondary objectives of the trial
    The secondary goals are detecting whether oxytocin administration induces side effects and mood changes, as detected by participant’s and caregiver’s reports, and whether oxytocin’s effects depend on gender and/or number of administrations. In addition, we aim to monitor the changes of peripheral oxytocin levels following intranasal oxytocin administration.
    1. Change from placebo condition in self-reported side effects associated with repeated acute administration of oxytocin
    2. Change from placebo condition in Caregiver’s rating of patient’s side effects and mood change associated with repeated acute administration of oxytocin
    3. Change from placebo condition in variation of oxytocin peripheral levels associated with acute administration of oxytocin
    4. Change from placebo condition in variation of gender-related behavioral differences associated with acute administration of oxytocin
    Confermare la sicurezza e la tollerabilità dell’ossitocina in confronto a placebo. Nello specifico si andrà a misurare l’eventuale presenza di:
    i) effetti collaterali associati al trattamento (ossitocina/placebo) riportati dal partecipante.
    ii) cambiamenti delle condizioni fisiche e/o dell’umore osservati dal caregiver successivamente al trattamento.
    iii) testare la sicurezza e la tollerabilità della somministrazione ripetuta in acuto di ossitocina/placebo
    iv) misurare variazioni del livello di ossitocina endogena a livello periferico
    v) misurare possibili differenze di genere nelle risposte alla somministrazione di ossitocina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - diagnosis of possible and probable behavioral variant FTD (bvFTD) based on clinical assessment, standard neuropsychological, functional, and neurobehavioral tests;
    - early and mild bvFTD (MMSE score=20);
    - stable (i.e., more than 2 months) medical treatment related to cognition or behaviour traditionally used for bvFTD, such as acetylcholinesterase inhibitors, memantine, anti-depressants, antipsychotic agents, other mood stabilizers, benzodiazepines.
    - ages 40-80;
    - both genders (women in menopausal status: females with amenorrhea for 12 months without an alternative medical cause. A high follicle stimulating hormone, FSH, level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy)
    - Males participants with female premenopausal partners must agree to use a double barrier method of contraception i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam, and agree to maintain this throughout the study. Oxytocin nasal sprays has not been studied in pregnant or lactating women.
    - normal or correct-to normal vision
    - to be able to read and understand Italian language (the language used for the study instructions and Consent Form);
    - to be able to sign the consent form (MMSE=20, the semantic fluency, TMT A-B, and Digit Span scores should not be below 2SD from the mean scores);
    - availability of a caregiver who consents to participate into all study sessions and complete specific tests. (We consider a caregiver the person who spends at least 8 hours a day with the patient).
    • diagnosi di possible e probabile bvFTD (grado lieve/moderata - MMSE score=20);
    • trattamento farmacologico stabile (> 2 mesi) per bvFTD
    • età compresa tra 40-80 anni;
    • sia uomini che donne (donne in stato postmenopausa e non in età fertile)
    • capace di leggere e comprendere la lingua Italiana
    • essere in grado di firmare il modulo di consenso (MMSE=20, fluenza semantica, TMT A-B, e Digit Span non inferiori a 2SD dai punteggi medi)
    • availability of a caregiver who consents to participate into all study sessions and complete specific tests.
    E.4Principal exclusion criteria
    - Severe bvFTD (MMSE < 20)
    - Speech difficulties that in the opinion of the investigator would be incompatible with neuropsychology and safety assessments
    - Inability to sign the consent form
    - Medical or neurological disorders of the central nervous system apart from FTD
    - Any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
    - History of a myocardial infarction within the last two years or congestive heart failure.
    - Current uncontrolled hypertension
    - Current bradycardia (rate < 50 beats per minute/bpm) or tachycardia (rate > 100 bpm)
    - Current hyponatremia (Na <135 mEq/L)
    - Psychiatric disorders (depression, bipolar disorder or schizophrenia)
    - Hormonal therapy
    - Premenopausal women
    - Males refusing to use a double barrier method of contraception throughout the study.
    - Abuse of alcohol and drugs during the last 6 months
    - Severe hepatic or renal impairment
    - Ischemic cardiomyopathy
    - Diagnosis of cancer not in remission since at least 10 years
    - Known allergy to food additive and preservatives used for nasal sprays (E 216, E 218 and chlorobutanol hemihydrate)
    - Use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug, whichever is longer.
    • bvFTD severa (MMSE < 20)
    • incapacità a firmare il modulo di consenso
    • disturbi neurologici diversi da FTD
    • disturbi psichiatrici (depressione, disturbo biploare, schizofrenia)
    • terapia ormonale
    • abuso di alcohol e droghe/sostanze illecite durante gli ultimi 6 mesi
    • grave insufficienza epatica o renale
    • cardiopatia ischemica
    • diagnosi di tumore non in remissione da almeno 10 anni
    • allergie note a conservanti usati per il confezionamento degli sprays (E 216, E 218 and
    chlorobutanol hemihydrate)
    E.5 End points
    E.5.1Primary end point(s)
    On each testing day, in the 2 hr following substance administration, oxytocin induces a 20% improvement of social cognition performances in the context of a placebo-controlled trial:
    • Increased accuracy (number of corrected responses) and decreased latency (speed in ms to provide responses) to recognize emotions on the emotion recognition task compared to placebo
    • Increased accuracy (number of corrected responses) and reduced latency (speed in ms to provide responses) to recognize intentions during the empathy assessment task
    • Compared to placebo, a compression of subjective time perception during social interactions and a dilation of subjective time perception when alone, which would be indicative of patient’s increased sensitivity to social stimuli.
    In confronto alla somministrazione di placebo, la somministrazione di ossitocina porta a:
    i) Migliore accuratezza e maggiore velocità nel riconoscimento delle emozioni altrui;
    ii) Numero di risposte corrette maggiori nel test di empatia (capacità di riconoscere l’intenzionalità, la cognizione e lo stato affettivo altrui);
    iii) Maggiore variazione nella percezione soggettiva del tempo quando in presenza e in assenza di interlocutori.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7, 14, 21, 28
    Giorno 7, 14, 21, 28
    E.5.2Secondary end point(s)
    With respect to the secondary measures, we anticipate the following endpoints:
    • No difference between oxytocin and placebo with respect to frequency of sides effects indicated by the participant on a checklist on each testing day
    • Increase of positive affect as reported by the caregiver.
    • Increase of peripheral oxytocin concentration after oxytocin treatment
    • Stronger effect of oxytocin in males than females (because the levels are lower in baseline)
    Regarding the measurement of oxytocin concentrations, before and after the IMP administration, patients’ 9 ml blood samples will be collected and analyzed using the high-performance liquid chromatography method. The blood collection is a moderate-painful and relatively low-intrusive procedure. The blood sample will be collected by expert nurses 10 minutes before the IMP administration and at the end of the first experimental da
    In confronto alla somministrazione di placebo, la somministrazione di ossitocina porta a:
    i) assenza di differenze significative nella tipologia e nella frequenza di effetti collaterali
    ii) aumento dello stato affettivo positivo, come riportato dal caregiver
    iii) aumento dei livelli endogeni di ossitocina a seguito della somministrazione del farmaco con principio attivo
    iv) Nei tasks sperimentali, gli effetti dell’ossitocina saranno più forti nei maschi che nelle femmine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7, 14, 21, 28
    Giorno 7, 14, 21, 28
    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 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 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 years3
    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 years3
    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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 52
    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)
    According to clinical practice
    Secondo pratica clinica
    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 Decision2019-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-20
    P. End of Trial
    P.End of Trial StatusOngoing
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