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    Summary
    EudraCT Number:2017-001168-39
    Sponsor's Protocol Code Number:SNR01-NaBen
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-06-26
    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 number2017-001168-39
    A.3Full title of the trial
    An Adaptive, Phase IIb/III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of NaBen® (sodium benzoate), a D-Amino Acid Oxidase Inhibitor, as an Add-on Treatment for schizophrenia in Adolescents.
    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 Benefits of NaBen® in Adolescents with Schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    SNR-01-NaBen
    A.4.1Sponsor's protocol code numberSNR01-NaBen
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01908192
    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.4.2CountryUnited States
    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.3.11 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 Schizophrenia in Adolescents
    E.1.1.1Medical condition in easily understood language
    Treatment for Schizophrenia in Adolescents
    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 PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study has two portions: Phase IIb and Phase III:
    The primary objective of the Phase IIb portion of this study is to evaluate NaBen® (sodium benzoate) (1000 mg/day) safety and effectiveness and to determine the final sample size needed in order to proceed with the Phase III part of this trial.
    The primary objective of the Phase III portion of this study is to evaluate the effectiveness of NaBen® (sodium benzoate) (1000 mg/day), as compared to Placebo (0 mg/day), in improving the negative and positive symptoms associated with schizophrenia in adolescents.
    E.2.2Secondary objectives of the trial
    This study has two portions: Phase IIb and Phase III:
    Phase IIb – The secondary objective of this portion of the study is to evaluate the safety and tolerability of NaBen® (sodium benzoate) (1000 mg/day) as compared to Placebo (0 mg/day).
    Phase III – The secondary objective of this portion of the study is to evaluate the safety and tolerability of NaBen® (sodium benzoate) (1000 mg/day), as compared to Placebo (0 mg/day).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are required to meet all of the following criteria for randomization into the study.
    1. Male or female subjects who are between 12 and 17 years of age inclusive
    2. Physician confirmed DSM-IV or -V diagnosis of schizophrenia based on the MINI International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders Studies for Children and Adolescents, version 6.0 (MINI-KID, Version 6.0) (Sheehan, 2010) (refer to Appendix 19.1)
    3. Are clinically stable with residual symptoms. Residual symptoms will be defined as a total score of ≥ 60 of PANSS and a score of ≥ 40 for SANS
    4. An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to randomization into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for
    Aripiprazole (Maintena®) and Paliperidone (Xeplion®); six (6) months for Olanzapine pamoate monohydrate (Zypadhera®); and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics)
    5. In good general physical health and all physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and electrocardiogram [ECG]) are clinically unremarkable per the Investigator
    6. Subject has a negative urine illicit drug screening test
    7. Subject understands and is willing to sign the IAF prior to study entry and agrees to be available for all the study visits
    8. The subject’s guardian understands and is willing to sign the ICF prior to study entry and agrees to be available for all the study visits
    9. Must not be a danger to self or others and must have family support available to be maintained as outpatients
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria will be excluded from randomization into the study:
    1. Meets the DSM-IV or -V criteria at screening for mental retardation, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance-induced psychotic disorder. Other comorbid disorders; e.g., attention-deficit hyperactivity disorder (ADHD), are allowed as long as schizophrenia is the primary diagnosis and the comorbid disorder(s) do not require medication.
    2. Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose
    3. History of epilepsy, head trauma, or neurological illness other than Tourette’s syndrome
    4. History of allergic reaction to sodium benzoate
    5. Serious medical illnesses such as acute or chronic renal disease, liver failure or heart disease that, in the opinion of the Investigator, may interfere with the conduct of the study.
    6. Current substance abuse or positive urine illicit drug screening or history of substance dependence (including alcohol, but excluding nicotine and caffeine) in the past three (3) months.
    7. Inability to follow protocol
    8. Body Mass Index (BMI) > 35
    9. Female subjects who are pregnant (as confirmed by urine pregnancy test performed at screening Visit) or are nursing, or who do not agree to abstinence or birth control during the study
    10. Cancer within the last three (3) years except for basal cell carcinoma and squamous cell carcinoma
    11. Previous participation in an intervention trial within 30 days of randomization
    12. Decrease in the PANSS total score by more than 10 percent using PANSS evaluations performed at Screening Visit 1 and Screening Visit 3
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for the study is:
    Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after six (6) weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 weeks of treatment
    E.5.2Secondary end point(s)
    SECONDARY EFFICACY ENDPOINTS
    • Percent change from baseline in Positive and Negative Syndrome Scale (PANSS) total score from baseline after 6 weeks of treatment
    • Percentage of subjects with 20% or more reduction in Positive and Negative Syndrome Scale (PANSS) total score from baseline after six (6) weeks of treatment
    • Percent change in Positive and Negative Syndrome Scale (PANSS) subscales
    • Percent change in Scale for Assessment of Negative Symptoms (SANS) total scores
    • Percent change in Scale for Assessment of Negative Symptoms (SANS) subscale scores

    ADDITIONAL EFFICACY ENDPOINTS
    • Percent change in Children's Global Assessment Scale (CGAS)
    • Percent change in Clinical Global Impression-Severity (CGI-S)
    • Percent change in Children's Depression Rating Scale-Revised (CDRSR)

    SAFETY ASSESSMENTS
    • Incidence of Treatment-Emergent Adverse Events (TEAE)
    • Incidence of withdrawals from the study due to TEAEs
    • Percent change in Simpson-Angus extrapyramidal side effects (SAS) scale
    • Percent change in Abnormal Involuntary Movement Scale (AIMS)
    • Percent change in Barnes Akathisia Rating Scale (BARS)
    • Assessment of suicidality per the Columbia-Suicide Severity Rating Scale (C-SSRS)
    • Changes and shifts in laboratory measurements over time
    • Changes in vital signs and weight over time
    • Changes in ECG parameters over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 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 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) 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 concerned9
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Poland
    Taiwan
    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 Yes
    F.1.1Number of subjects for this age range: 126
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 126
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects participating in this study are adolescent (12-17 years) with schizophrenia. Written informed assent and informed consent will be obtained for this study from all subjects and their guardians before any protocol-specific procedure.
    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 80
    F.4.2.2In the whole clinical trial 126
    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 subjects' current medication regimen. Patients who complete the study will to be treated by their physician in accordance with the clinical routine of the respective site and upon further discretion of the responsible physician. The IMP will not be made available for continuation of treatment after the patient has completed the study. 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 Decision2020-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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