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    Summary
    EudraCT Number:2017-004893-32
    Sponsor's Protocol Code Number:CL03-ORY-2001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-004893-32
    A.3Full title of the trial
    A multicentre, multinational, randomised, double-blind, placebo-controlled, 3-arm, 24-week parallel-group study to evaluate the safety, tolerability and preliminary efficacy of ORY-2001 in patients with mild-moderate Alzheimer's Disease. ETHERAL Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety, tolerability and preliminary efficacy of ORY-2001 in patients with mild-moderate Alzheimer's Disease
    A.3.2Name or abbreviated title of the trial where available
    ETHERAL
    A.4.1Sponsor's protocol code numberCL03-ORY-2001
    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 SponsorOryzon Genomics S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOryzon Genomics S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOryzon Genomics S.A.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressSant Ferran 74
    B.5.3.2Town/ cityCornellà de Llobregat, Barcelona
    B.5.3.3Post code08940
    B.5.3.4CountrySpain
    B.5.4Telephone number34671048676
    B.5.6E-mailcbego@oryzon.com
    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 No
    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 nameORY-2001
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNORY-2001
    D.3.9.2Current sponsor codeORY-2001
    D.3.9.3Other descriptive namePHENYLCYCLOPROPYLAMINE DERIVATIVES AND DUAL LSD1/MAO-B (LYSINE-SPECIFIC DEMETHYLASE 1 AND MONOAMINE OXIDASE-B) INHIBITOR
    D.3.9.4EV Substance CodeSUB179357
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.6 to 1.2
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer Disease
    E.1.1.1Medical condition in easily understood language
    Alzheimer 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 LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    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 and tolerability of two doses of ORY-2001 in patients with mild-moderate Alzheimer's Disease
    E.2.2Secondary objectives of the trial
    To investigate the effect of two doses of ORY-2001 on the clinical domains of Alzheimer´s Disease
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women 50-85 years of age
    2. Body mass index (BMI) of at least 18.5 kg/m2
    3. Probable AD diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
    4. MMSE score at Screening and Baseline Visits of at least 16 and not greater than 26
    5. Evidence of the AD pathophysiological process indicated by decreased levels of amyloid AB and increased levels of total Tau protein or phospho-Tau protein in CSF
    6. Ambulatory or ambulatory aided patient (i.e. walker or cane)
    7. Outpatient consulting a general practitioner, or a phsychiatrist/neurologist/geriatrician
    8. Formal education for more than 6 years
    9. Knowledgeable and reliable close relative/caregiver who will accompany the patient to all clinic visits during the study
    10. Prior treatment:
    a. Daily treatment with the same acetylcholinesterase inhibitor (oral donepezil, oral or transdermal patch rivastigmine, or oral galantamine) for at least 6 months prior the Screening Visit and on a stable dose (i.e. the patient’s individual maintenance dose) for at least 4 months prior to the Screening Visit and throughout the Screening Period (applicable for centres located in Spain, France and UK) or
    b. Patients with no previous AD treatment (i.e.: AChEI or memantine) before the Screening Visit. These AD treatment-naïve patients should not receive AD treatment other than ORY-2001 at any moment from Screening Visit and throughout the study (only applicable for centres located in France and UK)
    11. Stable pharmacological treatment of any other chronic condition for at least one month prior to screening – including anti-inflammatories
    12. Fertile male and female must use highly effective contraception, from the Screening Visit until 90 days after last dose of the IMP, defined as:
    a. A method with less than 1% failure rate (e.g. permanent sterilisation, hormone implants, hormone injections, intrauterine devices, or vasectomised partner)
    OR
    b. The use of two methods of contraception (e.g. one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectable and implants])
    *Following menarche and until becoming post-menopausal unless permanently sterile. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause
    13. Signed informed consent by patient (or legal representative, if applicable) and a close relative/caregiver prior to the initiation of any study specific procedure
    E.4Principal exclusion criteria
    1. Failure to perform screening or baseline examinations
    2. Hospitalisation or change of concomitant medication 1 month prior to Screening visit or
    during Screening Period
    3. Member or immediate family of the study personnel or subordinate (or immediate
    family of a subordinate) to any of the study personnel
    4. Patient under forced treatment
    5. Clinical, laboratory or neuroimaging findings consistent with:
    a. Other primary degenerative dementia; for instance, dementia with Lewy bodies,
    frontotemporal dementia, Huntington’s disease, Jakob-Creutzfeld Disease, Down’s
    syndrome
    b. Other neurodegenerative condition; for instance, Parkinson’s disease, amyotrophic
    lateral sclerosis
    c. Cerebrovascular disease: major infarct, one strategic or more than 2 lacunar infarcts
    or extensive white matter lesions as described by local radiologist
    d. Other central nervous system diseases; for instance, severe head trauma, tumours,
    subdural hematoma or other space occupying processes
    6. A current DSM-5 diagnosis of major depression, schizophrenia or bipolar disorder
    7. Positive results for tuberculosis (the status must be determined as usual clinical practice, i.e. by medical history, signs and symptoms), human immunodeficiency virus (HIV), hepatitis C or
    hepatitis B (hepatitis B surface antigen [HbsAg]) serology at the Screening Visit
    8. Clinically significant, advanced or unstable disease that may interfere with evaluation:
    a. Seizures disorders
    b. Respiratory insufficiency (partial pressure of oxygen <60 mm Hg and partial
    pressure of carbon dioxide >50 mmHg)
    c. Hepatic impairment (serum total bilirubin value, serum alanine aminotransferase
    [ALT], serum aspartate aminotransferase [AST] and gamma-glutamyltransferase
    [GGT] 1.5 x upper limit of normal [ULN])
    d. Renal insufficiency (serum creatinine >2mg/dl)
    e. Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy
    within 6 months before Screening Visit)
    f. Hypertension treatment with more than 2 drugs
    g. Atrioventricular block (type II / Mobitz II and type III), congenital long QT syndrome,
    sinus node dysfunction or prolonged QTcB-interval (males >450 msec and females
    >470 msec)
    h. Uncontrolled diabetes (Hb1Ac >7.5)
    i. Haematological disorders, especially thrombocytopenia (platelets <75 000/mm3) and
    neutropenia (neutrophils <1 500/mm3)
    j. Malignant tumours within the last 5 years other than basal cell or Stage 1 squamous cell carcinoma of the skin
    9. Disability that may prevent the patients from completing all study requirements; for
    instance, blindness, deafness, severe language difficulty
    10. Chronic drug intake of:
    a. Acenocoumarol, warfarin or digitoxin
    b. Antidepressants (other than selective serotonin reuptake inhibitors [SSRIs] or
    selective serotonin–norepinephrine reuptake inhibitors [SSNRIs]), neuroleptics or sedatives. Note 2: Short and medium half-life oral benzodiazepines (alprazolam, lorazepam, midazolam, oxazepam,
    temazepam) and Z-drugs (zaleplon, zolpidem, zoplicone) are allowed in occasional short term prescription. Patients should not take these medications within 24 hours before any study visit.)
    c. Memantine
    d. Systemic anticholinergics
    e. Nootropics; for instance, racetams, anphetamines, metylphenidate, levodopa,
    atomoxetina, preparations containing Gingko biloba or St John′s Wort
    f. Centrally active anti-hypertensive drugs (such as clonidine, a-methyldopa,
    guanidine, guanfacine)
    g. Corticosteroids or immunosuppressant
    h. Antipsychotics
    i. MAO inhibitors
    j. No regular intake of medications acting directly on central nervous system that investigator consider relevant to the study
    11. Treatment with anti-amyloid beta or anti-Tau protein monoclonal antibodies or other disease modifying strategies within three months or five half-lives, whichever is longer, prior to the Screening Visit
    12. Treatment with an active vaccine targeting amyloid beta or Tau protein
    13. Suspected or known drug or alcohol abuse
    14. Metallic implants or any other cause precluding the performance of brain MRI
    15. Enrolment in another investigational study within the previous 3 months
    16. Suicide attempt within the last year or significant risk of suicide (in the opinion of the investigator, defined as a “yes” to suicidal ideation questions 4 or 5, or answering “yes” to suicidal behaviour on the Columbia-Suicide Severity Rating Scale within the past 12 months)
    17. Any condition that in the opinion of the investigator makes the patient unsuitable for
    inclusion in the study
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    • Number, frequency and severity of Treatment Emergent Adverse Events (TEAEs) up to Week 24 and Week 48
    • Number, frequency and severity of Serious TEAEs up to Week 24 and Week 48
    • Number and percentage of withdrawn patients due to TEAEs up to Week 24 and Week 48
    • Change from baseline to Week 24 and Week 48 in physical examination, vital signs and ECG parameters
    • Frequency of physical examination parameters, vital signs and ECG parameters of potential clinical concern throughout the study period
    • Change from baseline to Week 24 and Week 48 in clinical laboratory parameters (haematology, including platelets) and clinical chemistry
    • Frequency of clinical laboratory parameters (haematology, including platelets, and clinical chemistry) of potential clinical concern throughout the study period
    • Use of concomitant medication throughout the study period
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 and 48 weeks
    E.5.2Secondary end point(s)
    Efficacy
    • Change from Baseline to Week 24 and Week 48 compared to placebo in the Cohen-Mansfield Agitation Inventory (CMAI)
    • Change over time compared to placebo in the CMAI
    • Change from Baseline to Week 24 and Week 48 compared to placebo in the Clinician version of the Apathy Evaluation Scale (AES-C)
    • Change over time compared to placebo in the AES-C
    • Change from Baseline to Week 12, Week 24 and Week 48 compared to placebo in the 14-item Alzheimer's Disease Assessment Scale-Cognitive
    • Change from Baseline to Week 12, Week 24 and Week 48 compared to placebo in the Computerised Cognitive Test battery
    • Change from Baseline to Week 24 and Week 48 compared to placebo in the MMSE
    • Change from Baseline to Week 24 and Week 48 compared to placebo in the Clinical Dementia Rating Scale Sum of Boxes
    • Change from Baseline to Week 24 and Week 48 compared to placebo in the Cornell Scale for Depression in Dementia (CSDD)
    • Change over time compared to placebo the CSDD
    E.5.2.1Timepoint(s) of evaluation of this end point
    12, 24, 48 weeks
    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 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 trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 Yes
    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
    LPLV
    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 months6
    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 months6
    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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 125
    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)
    Not different from the expected normal treatment for Alzheimer disease
    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 Decision2018-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
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