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    Summary
    EudraCT Number:2018-002901-68
    Sponsor's Protocol Code Number:
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-002901-68
    A.3Full title of the trial
    Double-blind, controlled, randomized phase 2 study of efficacy, safety, pharmacokinetics and pharmacodynamics of a daily oral administration of MAP4343 during 6 weeks in antidepressant-non responders patients experiencing a major depressive episode
    A.4.1Sponsor's protocol code number
    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 SponsorMAPREG
    B.1.3.4CountryFrance
    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 supportMAPREG
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEUROFINS OPTIMED
    B.5.2Functional name of contact pointYves DONAZZOLO
    B.5.3 Address:
    B.5.3.1Street Address1 rue des Essarts
    B.5.3.2Town/ cityGières
    B.5.3.3Post code38610
    B.5.3.4CountryFrance
    B.5.4Telephone number+330438 37 27 40
    B.5.5Fax number+3304 38 37 27 41
    B.5.6E-mailaecoptimed@eurofins.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 nameMAP4343
    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 INN3β-methoxy pregn-5-en-20-one
    D.3.9.1CAS number 511-26-2
    D.3.9.2Current sponsor codeMAP4343
    D.3.9.3Other descriptive name3β-methoxy pregnenolone, pregnenolone methyl ether
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Depression
    E.1.1.1Medical condition in easily understood language
    Neurology
    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 10012378
    E.1.2Term Depression
    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 at 6 weeks on Hamilton scale of daily administration of MAP4343 with anti-depressing drug in add-on in patients with drug resistant depression (resistance level from 2 to 4 according to Thase & Rush classification, 1997).
    E.2.2Secondary objectives of the trial
    - To determine the percentage of treatment responders patients (corresponding to a 50% decrease on Hamilton score) over the 6 weeks of treatment.
    - To determine the percentage of patients in remission (corresponding to a Hamilton score < 7) over the 6 weeks of treatment.
    - To evaluate the efficacy of MAP4343 from D1 to D43.
    - To evaluate the safety of MAP4343 in patients in add-on conditions.
    - To determine some pharmacodynamics parameters on brain morphology (structural MRI), brain response (functional MRI) and biomarkers (plasmatic quantification
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Antidepressant drug Resistance level from to 2 to 4 inclusive;
    2- Patient experiencing a Major Depressive Episod (MDE) according to DSM-V criteria. MDE can be isolated or recurrent. The diagnosis is based on Mini-International Neuropsychiatric Interview (MINI) test;
    3- Patient should have received a previous antidepressant treatment in monotherapy: IRSS, IRSNA, Tricyclique, IMAO or other drug class prescribed at the maximal dose recommended before the selection;
    4- Hamilton Depression Rating Scale (HDRS) scores > 21;
    5- Global clinical Impressions scale (GCI) > 4;
    6- Male or female patient, aged 18 to 65 years inclusive;
    7- Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm or condoms) for the duration of the trial and for 4 months after the last study drug administration;
    Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration at least 12 months);
    8- Negative pregnancy test at screening baseline;
    9- Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive;
    10- Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis, hormonology). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator;
    11- Normal ECG recording on a 12-lead ECG at the screening visit:
    o 120 < PR < 210 ms,
    o QRS < 120 ms,
    o QTcf ≤ 430 ms for male and < 450 ms for female,
    o No sign of any trouble of sinusal automatism,
    o Or considered NCs by investigators;
    12- Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position:
    o 95 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 140 mmHg,
    o 50 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg,
    o 50 bpm ≤ HR ≤ 80 bpm,
    o Or considered NCs by investigators;
    13- Signing a written informed consent prior to selection;
    14- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
    E.4Principal exclusion criteria
    1- MDE with mood congruent or not congruent psychotic characteristics;
    2- Patient hospitalized following the procedures: Psychiatric care at the request of another person (soins psychiatriques à la demande d’un tiers) or Psychiatric care at the request of the state representative (soins psychiatriques sur décision du représentant de l’Etat);
    3- suicidal risk in the last month before randomization (MINI 5.00; suicidal risk section or item 3 of HDRS≥3);
    4- History of other psychiatric disorder than DME except global anxiety, social phobia, panic troubles that should be accepted. In particular, patients who experienced a depressive state associated with bipolar disorder 1 or 2, schizophrenic or schizo-affective disorder should not be included;
    5- Presence or history of protein drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
    6- Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the time of study participation;
    7- Any drug intake during the last month prior to the first administration except those defined in Section 5.3;
    8- General anaesthesia within 3 months before administration;
    9- Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months;
    10- Positive HBs antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests;
    11- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant, calculated creatinine clearance ≤ 60 mL/min;
    12- Blood donation (including in the frame of a clinical trial) within 2 months before administration;
    13- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
    14- Medical history which in the opinion of the investigator would make the patient unsuitable for participation in the study (including, but not limited, to patients with coronary insufficiency, thromboembolism diseases);
    15- Exclusion period of a previous study;
    16- No possibility of contact in case of emergency
    17- History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day);
    18- Administrative or legal supervision;
    E.5 End points
    E.5.1Primary end point(s)
    HDRS score evolution between baseline and D43.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and D43
    E.5.2Secondary end point(s)
    - Efficacy: psychopathological evaluations at each study visit: HDRS, MADRS, BAS, CGI, QIDS-SR and GAF (only at D1 and D43).
    - Pharmacokinetic assessment: Cmax, tmax, AUCt, Kel, t1/2, AUCinf, %AUCextra, Vd/F, Cl/F, R for MAP4343 in plasma at each study visit from D1 to D43.
    - Safety parameters: AE, vital signs, 12-lead ECG, laboratory exams, physical exams.
    - Biomarkers evaluation by MRI at baseline and D43:
    o Hippocampal volume
    o Self-referential memory task
    o Sensitivity to reward and punishment
    o Cognitive tasks outside the MRI scanner
    MRI will be performed only in La Pitié Salpétrière hospital, Sainte-Anne and Michel Fontan

    - Plasmatic quantification of pregnenolone, CRPs, Interleukins 1, 6 and 10; ELK-1, BDNF and VEGF, tubulin isoforms acet and tyr
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: D1 and D43
    PK: D1, D8, D15, D22, D29, D36, D43
    Safety: during all the study
    MRI: Baseline and D43
    Plasmatic biomarkers: Baseline and D43
    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 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 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 concerned10
    E.8.5The trial involves multiple Member States No
    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 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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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: 110
    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 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 state110
    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)
    None
    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 Decision2018-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-11-07
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