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    Summary
    EudraCT Number:2017-005149-64
    Sponsor's Protocol Code Number:MIN-117C03
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-12
    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 ConcernedFinland - Fimea
    A.2EudraCT number2017-005149-64
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (5.0 mg or 2.5 mg) of MIN-117 in Adult Patients with Major Depressive Disorder
    Satunnaistettu, kaksoissokkoutettu, lumekontrolloitu, rinnakkaisryhmissä
    tehtävä tutkimus, jossa arvioidaan kahden kiinteän MIN-117 annoksen
    (5,0 mg ja 2,5 mg) tehokkuutta ja turvallisuutta vakavaa masennusta
    sairastavilla aikuisilla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder
    Kansainvälinen kliininen lääketutkimus, jossa tutkitaan uuden lääkkeen
    MIN-117 kahden annostason tehoa ja turvallisuutta vertaamalla
    lumelääkkeeseen masennuksen hoidossa
    A.4.1Sponsor's protocol code numberMIN-117C03
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03446846
    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 organisationPPRS
    B.5.2Functional name of contact pointDirector of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address4E Avenue du Général de Gaulle
    B.5.3.2Town/ city COLMAR
    B.5.3.3Post code68000
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 3 89 24 16 86
    B.5.6E-mailelu@pprs-research.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-117
    D.3.2Product code MIN-117
    D.3.4Pharmaceutical form Capsule, hard
    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 INNN/A
    D.3.9.1CAS number 310392-93-9
    D.3.9.2Current sponsor codeMIN-117
    D.3.9.3Other descriptive nameMIN-117
    D.3.9.4EV Substance CodeSUB177452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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, hard
    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
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Depression
    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 LLT
    E.1.2Classification code 10025454
    E.1.2Term Major depressive disorder, recurrent episode
    E.1.2System Organ Class 100000004873
    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 2 fixed doses (5.0 mg or 2.5 mg) of MIN-117 compared with placebo in reducing the symptoms of major depression measured by the change in Montgomery-Asberg Depression Rating Scale (MADRS) total score over 6 weeks of treatment in adult patients with major depressive disorder (MDD).
    E.2.2Secondary objectives of the trial
    1. To assess the change from Baseline of 2 fixed doses (5.0 mg or 2.5 mg) of MIN-117 compared with placebo over 6 weeks of treatment on:
    • The symptoms of anxiety using the Hamilton Anxiety Scale (HAM-A).
    • The severity of illness and improvement using the Clinical Global Impression of Severity Scale and Clinical Global Impression of Improvement Scale (CGI S and CGI-I).
    2. To evaluate the safety of 2 fixed doses (5.0 mg or 2.5 mg) of MIN-117 compared with placebo over 6 weeks of treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must be able to read and understand the consent forms, complete study-related procedures, and communicate with the study staff.
    2. Patients must have provided written consent to participate in the study and understand that they are free to withdraw from the study at any time.
    3. Patients must be aged 18 to 65 years, inclusive, at Screening (Visit 1).
    4. Meet DSM-5 criteria for diagnosis of moderate or severe major depression with anxious distress and without psychotic features at Screening based on clinical assessment and on the SCID-5 (DSM-5 codes: 296.32, 296.33; ICD-10 codes: F33.1, F33.2). Their major depressive episode must be deemed "valid" using the Massachusetts General Hospital (MGH) SAFER criteria interview administered by remote, independent raters.
    5. Patients must be within a body mass index (BMI) of ≥ 18 to < 35 kg/m2 [BMI = weight (kg)/height (m)2] at Screening (Visit 1).
    6. Patients have a history of at least one previous episode of depression prior to the current episode.
    7. Patient must have been treated with an antidepressant administered at an adequate dose and duration in the past for the treatment of Major Depression. An adequate treatment is defined as an antidepressant treatment for at least 4 weeks at at least the minimum therapeutic dose, for any particular antidepressant.
    8. Current major depressive episode of at least 4 weeks in duration.
    9. At Screening (Visit 1) and Baseline (Visit 2), patients must have a score ≥ 40 on the patient rated IDS SR30.
    10. At Screening (Visit 1) and Baseline (Visit 2), patients must have a score ≥ 18 on HAM-A.
    11. At Screening (Visit 1) and Baseline (Visit 2), patients must have a score ≥ 4 on the investigator-rated CGI-S.
    12. Patients must be in good general health prior to study participation with no clinically relevant abnormalities as assessed by the investigator and determined by: medical history, physical examination, vital signs, blood chemistry, hematology, urinalysis, and electrocardiogram (ECG).
    13. If female, the patient must:
    • be post-menopausal, or
    • have had a hysterectomy or tubal ligation or be otherwise incapable of pregnancy, or
    • must agree to consistent use of contraception for the duration of the study (oral or parenteral hormonal contraceptive or intrauterine device or barrier plus spermicide).
    E.4Principal exclusion criteria
    1. A DSM-5 diagnosis of current (active): panic disorder, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa.
    2. History or current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders, mood disorder with postpartum onset, somatoform disorders, fibromyalgia, or idiopathic medical conditions.
    3. At significant clinical risk for suicidal or violent behavior.
    4. Potential patient who demonstrate a greater than 25% decrease in depressive symptoms as reflected by the IDS-SR30 total score from Screening visit to Baseline visit.
    5. Active cardiovascular disease (including but not limited to: atrial fibrillation or flutter, second and third-degree atrioventricular heart block, resting supraventricular tachycardia >100 beats per minute, unstable ischemic heart disease, valvular abnormality, sick sinus syndrome or other condition requiring pacemaker) or diastolic blood pressure > 105 mmHg.
    6. Any serious, untreated, or unstable illnesses, such as: liver or renal insufficiency.
    7. Any significant pulmonary, endocrine, or metabolic disturbances.
    8. Documented disease of the central nervous system that could interfere with the study assessments (including but not limited to: stroke, tumor, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, seizure disorder requiring current anti-convulsants, traumatic brain injury or trauma, and neurosyphilis.
    9. Hypothyroidism or hyperthyroidism, unless stabilized by appropriate medication for at least 3 months prior to Screening (a normal thyroid-stimulating hormone [TSH] is required prior to randomization at Baseline).
    10. Any medical condition that can potentially alter oral enteral absorption (e.g., gastrectomy), metabolism (e.g., liver failure), or excretion (e.g., renal failure) of the study drug.
    11. History of alcohol or substance use disorders (except nicotine and caffeine) meeting DSM-5 criteria within 1-year prior to Screening visit.
    12. Positive alcohol and urine drug screen for opiates, cocaine, barbiturates, tetrahydrocannabinol, methadone, and amphetamine/methamphetamine at Screening and randomization.
    13. QTcF interval at Screening or Baseline greater than 450 msec for males and 470 msec for females.
    14. Positive hepatitis B surface antigen, or hepatitis C antibody or Human Immunodeficiency Virus (HIV) 1 and 2 antibodies at Screening.

    E.5 End points
    E.5.1Primary end point(s)
    Mean change in the MADRS total score from Baseline to Week 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The mean change from Baseline to Week 6 in MADRS total score
    E.5.2Secondary end point(s)
    1) Change in symptoms of anxiety using the Hamilton Anxiety scale (HAM-A)
    2) Changes in the severity of illness and improvement using the Clinical Global Impression of Severity Scale (CGI-S) and Clinical Global Impression of Improvement Scale (CGI-I).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) mean change from Baseline to Week 6 in HAM-A total score
    2) mean changes in CGI-S and CGI-I from Baseline to Week 6
    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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Bulgaria
    Finland
    Poland
    Ukraine
    United States
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 292
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 134
    F.4.2.2In the whole clinical trial 324
    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 PI will provide her/his patient with standard of care for major depressive disorder as relevant.
    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 Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-21
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