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    Summary
    EudraCT Number:2014-004878-42
    Sponsor's Protocol Code Number:MIN-101C03
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Suspended by CA
    Date on which this record was first entered in the EudraCT database:2015-03-12
    Trial results View 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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2014-004878-42
    A.3Full title of the trial
    A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of MIN-101 in Patients With Negative Symptoms of Schizophrenia, Followed by a 24-Week, Open-Label Extension.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy, Safety, and Tolerability of MIN-101 in Patients With Negative Symptoms of Schizophrenia.
    A.4.1Sponsor's protocol code numberMIN-101C03
    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 SponsorMinerva Neurosciences, Inc.
    B.1.3.4CountryUnited States
    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 supportMinerva Neurosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKCR S.A.
    B.5.2Functional name of contact pointSYMPHONIA - helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressPostepu 6
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-676
    B.5.3.4CountryPoland
    B.5.4Telephone number0048223131313
    B.5.6E-mailmin-101@kcrcro.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 nameMIN-101
    D.3.2Product code MIN-101
    D.3.4Pharmaceutical form Modified-release 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 INNMIN-101
    D.3.9.1CAS number 359625-80-2
    D.3.9.2Current sponsor codeMIN-101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    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 placeboTablet
    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
    Schizophrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    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 19.0
    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
    To evaluate the efficacy of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score of the pentagonal model over 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of MIN-101 compared to placebo in improving other symptoms of schizophrenia as measured by the change from Baseline in the PANSS total score, positive symptoms score, dysphoric mood, activation, and autistic preoccupation subscores of the pentagonal model over 12 weeks of double-blind treatment.
    -To evaluate the efficacy of MIN-101 compared to placebo in improving symptoms of schizophrenia as measured by the change from Baseline in the PANSS total score and subscores according to the 3 factors analysis over 12 weeks of double-blind treatment.
    - To evaluate the efficacy of MIN-101 compared to placebo in improving negative symptoms of schizophrenia as measured by the change from Baseline in the Brief Negative Symptoms Scale (BNSS) total score over 12 weeks of double-blind treatment.
    - To assess the effects of MIN-101 compared to placebo on the CGI-S and CGI-I over 12 weeks of double-blind treatment.
    For futher information please see protocol section 2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient or patient's legal representative has provided informed consent.
    2. Male or female patient, 18 to 60 years of age, inclusive.
    3. Patient meets the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V), as established by a full psychiatric interview in conjunction with the Mini International Neuropsychiatric Interview (MINI).
    4. Patient is stable in terms of positive symptoms of schizophrenia over the last 3 months according to his or her treating psychiatrist
    5. Patient is stable in terms of negative symptoms of schizophrenia over the last
    3 months according to his or her treating psychiatrist
    6. Patient with PANSS negative subscore of at least 20.
    7. Patient with PANSS item score of <4 on:
    -P4 Excitement, hyperactivity
    - P7 Hostility
    - P6 Suspiciousness
    - G8 Uncooperativeness
    - G14 Poor impulse control
    8. Patients can be on any psychotropic as long as the psychotropic can be discontinued at the beginning of the washout phase without endangering the patient’s safety.
    9. No change in any psychotropic medication during the last month (changes are allowed if done for administrative reasons or with the permission of the Sponsor’s Responsible Medical Officer).
    10. No history of violence against self, others, or property.
    11. Patient in whom, in the opinion of the investigator, a switch to another antipsychotic medication or initiation of an antipsychotic medication is indicated.
    12. Female patient, if of childbearing potential, must test negative for pregnancy and must be using a double barrier contraceptive method.
    13. Patient must be extensive metabolizers for P450 CYP2D6, as determined by genotyping test before the first drug dose is administered.
    14. Patient must be able to understand the nature of the study.
    15. The patient is considered by the investigator to be reliable and likely to cooperate with the assessment procedures.
    E.4Principal exclusion criteria
    1. Current bipolar disorder, panic disorder, obsessive compulsive disorder, or evidence of mental retardation.
    2. Patient’s condition is due to direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical condition.
    3. Significant risk of suicide or attempted suicide, or of danger to self or others.
    4. Patient has a history of substance abuse within 3 months of the Screening visit (excluding caffeine and cigarette smoking).
    5. Positive urine drug screen except when related to prescribed benzodiazepines and opiates recently prescribed for an episode of acute pain (e.g., dental extraction).
    6. Patient who cannot be discontinued from psychotropics other than those allowed.
    7. Patient who received clozapine within 6 months of the Screening visit.
    8. Patient receiving treatment with depot antipsychotic medication can be enrolled in the study 4 weeks after the last injection.
    9. Patient with a history of significant other major or unstable neurological, neurosurgical (e.g., head trauma), metabolic, hepatic, renal, hematological,
    pulmonary, cardiovascular, metabolic, gastrointestinal, or urological disorder.
    10. Patient with a history of epilepsy seizure disorder (patient with a history of childhood febrile seizure may be enrolled in this study).
    11. Patient who has had electroconvulsive therapy (ECT), vagal nerve stimulation (VNS), or repetitive trans-cranial magnetic stimulation (r-TMS) within the 3 months prior to the Screening visit or who are scheduled for ECT, VNS, or r-TMS at any time during the study.
    12. Patient with clinically significant abnormalities in hematology, blood chemistry, ECG, or physical examination not resolved by the Baseline visit.
    13. Body Mass Index (BMI) > 35.
    14. Current systemic infection (e.g., Hepatitis B virus [HBV], Hepatitis C virus [HCV], human immunodeficiency virus [HIV], tuberculosis [TB]). Patients with positive Hepatitis B core antibody test and negative Hepatitis B Surface Antigen (HBsAg) may be included in the study if aminotransferase levels (alanine aminotransferase/ serum glutamic pyruvic transaminase (ALT/SGPT) and aspartate aminotransferase/ serum glutamic oxaloacetic transaminase (AST/SGOT) do not exceed 2 times upper limit of normal (ULN).
    15. Patient who requires or may require concomitant treatment with any other medication likely to increase QT interval (e.g., paroxetine, fluoxetine, duloxetine, amiodarone).
    16. Patient who requires medication inhibiting the CYP 2D6. 17. Patient with a clinically significant electrocardiogram (ECG) abnormality that could be a safety issue in the study, including QT interval value corrected for heart rate using the Fridericia’s formula (QTcF) > 430 msec for males and > 450 msec
    for females.
    18. Patient with a history of myocardial infarction based on medical history or ECG findings at Screening.
    19. Familial or personal history of long QT syndrome or with additional risk factors for torsade de Pointes (e.g., hypokalemia, hypomagnesemia).
    20. Woman of child-bearing potential, or man, who are unwilling or unable to use accepted methods of birth control.
    21. Woman with a positive pregnancy test, is lactating, or is planning to become pregnant during the study.
    22. Patient who participated in another clinical study within 3 months prior to Screening.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in PANSS negative subscale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Weeks 2, 4, 8, 12
    E.5.2Secondary end point(s)
    Change from baseline in the PANSS total score and Positive, Dysphoric mood, Activation, and Autistic preoccupation subscores of the pentagonal model
    Change from Baseline in the PANSS total score and subscores according to the 3 factors analysis
    Change from baseline in the Brief Negative Symptoms Scale
    Change from baseline in Brief Assessment of Cognition in Schizophrenia
    Change from baseline in CGI-S and CGI-I
    Safety and tolerability (assessed through physical examination, adverse event reporting, electrocardiogram, vital signs assessment, Sheehan suicidality scale, Abnormal Involuntary movement Scale )
    Persistence of efficacy, and the safety and tolerability of MIN-101 during the 24-week, open-label extension phase.

    E.5.2.1Timepoint(s) of evaluation of this end point
    For: Change from baseline in the PANSS total score and Positive, Dysphoric mood, Activation, and Autistic preoccupation subscores of the pentagonal model- Baseline and Weeks 2, 4, 8, 12
    For: Change from Baseline in the PANSS total score and subscores according to the 3 factors analysis-and Change from baseline in the Brief Negative Symptoms Scale - Baseline and Weeks 2, 4, 8, 12
    For: Change from baseline in Brief Assessment of Cognition in Schizophrenia- Baseline and Weeks 4 and 12
    For: Change from baseline in CGI-S and CGI-I-Baseline and Weeks 4, 8, 12
    For: Safety and tolerability (assessed through physical examination, adverse event reporting, electrocardiogram, vital signs assessment, Sheehan suicidality scale, Abnormal Involuntary movement Scale ) - over 12 weeks of 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    Tolerability
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Russian Federation
    Ukraine
    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 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: 234
    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
    Patients suffer for Schizophrenia disease.

    Patient or patient's legal representative has to provide informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 234
    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)
    standard of care
    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 Decision2015-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-09
    P. End of Trial
    P.End of Trial StatusSuspended by CA
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