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    Summary
    EudraCT Number:2018-002877-23
    Sponsor's Protocol Code Number:1.0
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-12-07
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-002877-23
    A.3Full title of the trial
    Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study.
    Oxytocin und soziale Aufmerksamkeit bei gesunden Kontrollen und Patienten mit der Parkinson Erkrankung. Eine randomisierte, doppelblinde, plazebokontrollierte Eye tracking Studie im Cross-over Design.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study.
    Oxytocin und soziale Aufmerksamkeit bei gesunden Kontrollen und Patienten mit der Parkinson Erkrankung. Eine randomisierte, doppelblinde, plazebokontrollierte Eye tracking Studie im Cross-over Design.
    A.3.2Name or abbreviated title of the trial where available
    Oxytocin in healthy controls and PD
    Oxytocin bei gesunden Kontrollen und Parkinson
    A.4.1Sponsor's protocol code number1.0
    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 SponsorAbteilung für Neurologie der Medizinischen Universität Innsbruck
    B.1.3.4CountryAustria
    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 supportMedical University Innsbruck
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University Innsbruck
    B.5.2Functional name of contact pointClinical Trial Center Neurology
    B.5.3 Address:
    B.5.3.1Street AddressAnichstraße 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number+4351250483571
    B.5.5Fax number+4351250425819
    B.5.6E-mailphilipp.ellmerer@i-med.ac.at
    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 40 IU/ml nasal spray
    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.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSynthetic Oxytocin
    D.3.9.1CAS number 50-56-6
    D.3.9.3Other descriptive nameOXYTOCIN SYNTHETIC
    D.3.9.4EV Substance CodeSUB179773
    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 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
    Social functioning in Parkinson's disease
    Sozial-kognitive Funktionen bei der Parkinson Erkrankung
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    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
    To assess the effects of oxytocin in social saliency and emotional perception in healthy controls and patients with Parkinson's disease.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for participants with PD:
    1. Age 30 – 70 years
    2. Male
    3. Confirmed diagnosis of idiopathic Parkinson’s disease for at least 3 years according to the UK Brain Bank criteria
    4. On a stable regimen of anti-parkinson medication (such as L-Dopa, Amantadine, Anticholinergics, COMT inhibitors, dopamine agonists and MAO-B inhibitors) for at least three weeks prior to screening and willing to continue the same doses and regimens during study participation
    5. Any other current and allowed prescription/ non prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least three weeks prior to screening, and participants must be willing to continue the same doses and regimens during study participation
    6. Able and willing to sign a current IRB-approved informed consent form
    7. Acceptable method of contraception

    Inclusion criteria for healthy controls:
    1. Participants without PD or significant neurological disorder
    2. Age 30 - 70 years
    3. Male
    4. Able and willing to sign a current IRB-approved informed consent form
    5. Acceptable method of contraception
    E.4Principal exclusion criteria
    Exclusion criteria for participants with PD:
    1. Participants taking prostaglandins and/or vasoconstrictors/sympathomimetics (eg. COPD/asthma medication such as salbutamol, fenoterol; inotropics such as dobutamin; rhinitis therapy such as ephedrine), as oxytocin can interact with these drugs
    2. Current or recent (within 30 days or 5 half-times of the IMP, prior to screening) participation in another study with an investigational medicinal product
    3. Known allergy or hypersensitivity to any component of the IMPs
    4. Females
    5. Atypical or secondary parkinsonism (such as vascular Parkinsonism, drug induced Parkinsonism, Wilson’s disease, Alzheimer’s disease and Creutzfeld-Jacob disease)
    6. Known abnormality in CT or MRI brain imaging which is considered to cause neurological symptoms or deficits
    7. Concurrent dementia defined by MMSE ≤24
    8. Presence of an acute or chronic major psychiatric disorder (e.g., hallucinations, agitation, paranoia)
    9. History of severe cardiac disease (Angina, myocardial infarction, atrial fibrillation or cardiac surgery in the preceding two years)
    10. History of end stage kidney or liver disease
    11. Any other uncontrolled disease or any disease considered relevant by the investigator
    12. Nicotine consumption of more than 10 cigarettes per day
    13. Known allergy or hypersensitivity to latex rubber, due to possible cross-reactions
    14. Patient is legally incapacitated or persons held in an institution by legal or official order
    15. Persons with any kind of dependency on the investigator or employed by the Sponsor or investigator

    Exclusion Criteria for healthy controls:
    1. Participants taking prostaglandins and/or vasoconstrictors/sympathomimetics (eg. COPD/asthma medication such as salbutamol, fenoterol; inotropics such as dobutamin; rhinitis therapy such as ephedrine), as oxytocin can interact with these drugs
    2. Current or recent (within 30 days or 5 half-times of the IMP, prior to screening) participation in another study with an investigational medicinal product
    3. Known allergy or hypersensitivity to any component of the IMPs
    4. Females
    5. Any known neurological disease
    6. Known abnormality in CT or MRI brain imaging which is considered to cause neurological symptoms or deficits
    7. Concurrent dementia defined by MMSE ≤24
    8. Presence of an acute or chronic major psychiatric disorder (e.g., hallucinations, agitation, paranoia)
    9. History of severe cardiac disease (Angina, myocardial infarction, atrial fibrillation or cardiac surgery in the preceding two years)
    10. History of end stage kidney or liver disease
    11. Any other uncontrolled disease or any disease considered relevant by the investigator
    12. Nicotine consumption of more than 10 cigarettes per day
    13. Known allergy or hypersensitivity to latex rubber, due to possible cross-reactions
    14. Personality change (eg. increased aggression potential, irritability, at risk for substance abuse disorder/impulsive-compulsive behavior)
    15. Participantis legally incapacitated or persons held in an institution by legal or official order
    16. Persons with any kind of dependency on the investigator or employed by the Sponsor or investigator
    E.5 End points
    E.5.1Primary end point(s)
    •Number of fixations towards social stimuli in naturalistic scenes
    •Duration of fixations towards social stimuli in naturalistic scenes
    •Latency to first fixation towards social stimuli
    •Number of fixations towards the eye region
    •Duration of fixations towards the eye region
    •Latency to first fixation towards the eye region
    •Error rate in recognizing emotions
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening
    Visit 1
    Visit 2
    E.5.2Secondary end point(s)
    •Changes in reaction times in pro- and antisaccadic tasks (ms)
    •Changes in errorrates in pro- and antisaccadic tasks
    •Changes in the score of the Delayed Discounting Test

    Safety and tolerability endpoints:
    •Tolerability
    •Number of subjects (%) who discontinue the study
    •Number of subjects (%) who discontinue the study due to AE
    •Safety Measures
    •Adverse Events (AE)
    •Clinical assessments
    •Vital signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening
    Visit 1
    Visit 2
    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 No
    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
    Exploratory study on effects of oxytocin on emotional perception in healthy controls and patients with Parkinson's disease.
    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.8.5The 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
    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 months0
    E.8.9.1In the Member State concerned 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state76
    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)
    Participants will have a Safety Telefone Call after their last visit. Patients will continue their regular visits in our out-Patient clinic.
    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 Decision2019-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-11-15
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