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    Summary
    EudraCT Number:2017-001170-42
    Sponsor's Protocol Code Number:SNR05
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-10-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-001170-42
    A.3Full title of the trial
    An adaptive Phase II/III, Double-Blind, Randomized, Placebo-controlled, Two-Part, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen® (sodium benzoate), a D-Amino Acid Oxidase Inhibitor, as an Add-on with Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Two-part Clinical Study to Evaluate the Safety and Efficacy of NaBen® in Adults with Refractory Schizophrenia
    A.4.1Sponsor's protocol code numberSNR05
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03094429
    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 SponsorSyneuRx International (Taiwan) Corp
    B.1.3.4CountryTaiwan
    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 supportSyneuRx International (Taiwan) Corp
    B.4.2CountryTaiwan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmarex Clinical Research, LLC
    B.5.2Functional name of contact pointContract Research Organisation
    B.5.3 Address:
    B.5.3.1Street Address20201 Century Blvd
    B.5.3.2Town/ cityGermantown
    B.5.3.3Post code20874
    B.5.3.4CountryUnited States
    B.5.4Telephone number13015287000
    B.5.5Fax number13015282300
    B.5.6E-mailyashars@amarexcro.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 nameNaBen®(F.C.T.II)
    D.3.2Product code NaBen®(F.C.T.II)
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSODIUM BENZOATE
    D.3.9.1CAS number 532-32-1
    D.3.9.2Current sponsor codeNaBen F.C.T. II
    D.3.9.3Other descriptive nameSODIUM BENZOATE
    D.3.9.4EV Substance CodeSUB12577MIG
    D.3.10 Strength
    D.3.10.1Concentration unit millilitre(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboFilm-coated tablet
    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
    Treatment for Refractory Schizophrenia in Adults
    E.1.1.1Medical condition in easily understood language
    Treatment for treatment-resistant Schizophrenia in Adults
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The 2 primary objectives for Part 1 of this study are:
    1. To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults, and; to determine the optimal dose to be used in Part 2 of this study.
    2. Sample size re-assessment to evaluate the final sample size needed to proceed with the Part 2 of the study
    The primary objective of Part 2 of this study is to evaluate the effectiveness of NaBen® (at the optimal dose determined in Part 1 of this study) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults.
    E.2.2Secondary objectives of the trial
    The secondary objective of Part 1 of this study is to evaluate the safety and tolerability of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), in combination with clozapine.
    The secondary objective of Part 2 of this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose determined in Part 1 of this study) compared to Placebo (0 mg/day), in combination with clozapine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects who are between 18 and 55 years of age inclusive
    2. Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements, or the subject has a Legally Authorized Representative (LAR) who can provide consent to be enrolled into the study.
    3. If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an Intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) "double-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL
    4. The subject has Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject’s recorded history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0).
    5. The subjects should have refractory schizophrenia as defined below (should meet at least two: either a and b; or a and c; or a and b and c):
    a.Prior non-response to at least 2 antipsychotic drugs of two different chemical classes for at least 4-6 weeks each at doses ≥ 400 mg equivalents of chlorpromazine or 4 mg/day risperidone, AND
    b.No period of good functioning in previous 2 years; OR,
    c.Moderate to severe psychopathology (total PANSS score equal or more than 70): including persistent psychotic symptoms, recurrent mood symptoms, repeated suicide attempts or suicidal ideation, uncontrolled aggressive behavior, moderate to severe positive or negative symptoms or moderate-severe cognitive impairment
    6. The subject has been receiving clozapine for a minimum of 6 months with the dose range of 200-900 mg/day. The dose should have remained unchanged for at least 3 months prior to Screening and not expected to change during the study.
    7. The subject is outpatient, and has been consistently symptomatic without significant fluctuation per the Investigator, with no hospitalization for worsening of schizophrenia within 3 months of the Screening. If the subject is hospitalized during the study for worsening of schizophrenia symptoms the subject will be withdrawn from the study.
    8. The subject has a minimum PANSS total score of 70 at the Screening and Baseline Visits (Visit 1 and Visit 2)
    9. Without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For ALT and AST, clinically significant is defined as above two and a half times the upper limit of normal
    10. Body Mass Index (BMI) between 17 and 38 inclusive
    11. Subject has a negative routine urine illicit drug screening test (including heroin, amphetamines (including MDMA/ecstasy), cocaine, cannabis or PCP)
    12. The subject has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker or nurse) as determined by the Investigator and per the local regulations. The identified caregiver should be considered reliable by the Investigator and per the local regulations in providing support to the subject to help ensure compliance with study treatment, study visits and protocol procedures who preferably is also able to provide input helpful for completing study rating scales.
    13. The subject must not be a danger to themselves or others per the Investigator’s judgment.
    E.4Principal exclusion criteria
    1. Meets the DSM-V criteria at Screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation
    2. Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to Screening
    3. Initiation or dose change of benzodiazepines or sleep medications, or any other psychotropic medications due to worsening of schizophrenia symptoms or medication side effects within four (4) weeks prior to Screening
    Exclusion Criteria:
    Subjects are required to meet NONE of the following criteria for randomization into the study:
    1. Meets the DSM-V criteria at Screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation
    2. Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to Screening
    3. Initiation or dose change of benzodiazepines or sleep medications, or any other psychotropic medications due to worsening of schizophrenia symptoms or medication side effects within four (4) weeks prior to Screening
    4. The subject has previously received NaBen®
    5. History of epilepsy, major head trauma, or any neurological illness other than Tourette’s syndrome which might impair the subject’s cognition or psychiatric functioning per the Investigator’s judgment
    6. History of allergic reaction to sodium benzoate
    7. Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator, may interfere with the conduct of the study
    8. Any significant gastrointestinal disorders that, in the opinion of the Investigator, markedly alter the absorption, metabolism or elimination of sodium benzoate
    9. Any movement disorder that might affect the ratings on the EPS scales (e.g. Parkinson’s disease) or any movement disorder that is due to antipsychotic medications and is not currently controlled with anti-EPS medications
    10. Current substance abuse, or history of meeting criteria for moderate or severe substance abuse and/or substance dependence (including alcohol, but excluding nicotine and caffeine) in the past six (6) months prior to Screening
    11. Female subjects who are pregnant (as confirmed by serum pregnancy test performed at Screening Visit) or are breast feeding
    12. History of cancer not in remission for the last three (3) years except for basal cell carcinoma and squamous cell carcinoma
    13. Participation in a clinical trial within 3 months prior to Screening or more than two clinical trials within 12 months
    14. Electroconvulsive Therapy (ECT) within 6 months prior to Screening
    15. The subject started a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months prior to Screening (e.g. individual psychotherapy, cognitive behavioral therapy or rehabilitative therapy)
    16. The subject’s anti-EPS medications dose or regimen has changed within 2 weeks prior to Screening
    17. The subject’s PANSS total score has decreased more than 20 percent using PANSS score evaluations at Visit 1 and Visit 2
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks of randomized treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 8 weeks of treatment
    E.5.2Secondary end point(s)
    • Percent change from baseline in PANSS total score after 8 weeks of treatment
    • Percentage of subjects with 20% or more reduction from baseline in PANSS total score after 8 weeks of treatment
    • Percent change in PANSS sub-scales and Marder PANSS factor scores
    • Percent change in Personal and Social Performance (PSP) scale
    • Percent change in Schizophrenia Quality of Life Scale (SQLS)
    • Percent change in Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I)
    • Percent change in Hamilton Depression Rating Scale (HDRS)
    • Serum pharmacokinetic evaluations
    • Serum DNA evaluations
    • Serum neurotransmitter markers evaluations
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 8 weeks of randomized treatment
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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
    There will be “DNA” and “SERUM BIOMARKER EVALUATIONS” per protocol.
    Samples will be collected for DNA testings of the study subjects. This evaluation will be used to find out more about the sub-populations who might be more responsive to the DAAO Inhibitors. for biomarkers, two groups of biomarkers (Monoamines and Amino acids) will be tested.
    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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Canada
    Germany
    Poland
    Taiwan
    United Kingdom
    United States
    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
    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
    E.8.9.2In all countries concerned by the trial years2
    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: 287
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 287
    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 IMP treatment is add-on to the standard of care, on subjects who have been on clozapine regimen. When the subjects are done with the study, the only change will be removal of NaBen therapy, the subjects will keep receiving their baseline medication regimen as before. The Sponsor will not provide their standard of care medications.
    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 Decision2019-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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