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    Summary
    EudraCT Number:2015-002578-20
    Sponsor's Protocol Code Number:ESN364_HF_204
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-002578-20
    A.3Full title of the trial
    Pilot/Phase IIa Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot/Phase IIa Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
    A.4.1Sponsor's protocol code numberESN364_HF_204
    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 SponsorEuroscreen S.A
    B.1.3.4CountryBelgium
    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 supportEuroscreen S.A
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuroscreen S.A
    B.5.2Functional name of contact pointSteven Ramael
    B.5.3 Address:
    B.5.3.1Street Address 47 Rue Adrienne Bolland
    B.5.3.2Town/ cityGosselies
    B.5.3.3Post code6047
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3271348 510
    B.5.5Fax number+3271348 519
    B.5.6E-mailsramael@euroscreen.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.3.2Product code ESN-364
    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.3.9.1CAS number not assigned
    D.3.9.2Current sponsor codeESN-364
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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
    hot flashes
    E.1.1.1Medical condition in easily understood language
    hot flashes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10020407
    E.1.2Term Hot flashes
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the effect of ESN364 on the severity and frequency of hot flashes in early postmenopausal women suffering from hot flashes, in terms of changes in weekly Hot Flash Score from baseline to Week 12.
    E.2.2Secondary objectives of the trial
    -effect of ESN364 on the frequency of hot flashes, in terms of changes in weekly Hot Flash Frequency from baseline to Week 12;
    -effect of ESN364 on the severity and frequency of hot flashes in terms of changes in weekly Hot Flash Score and Hot Flash Frequency and severity from baseline to Weeks 4 and 8, and at fu;
    -effect of 12-week administration of ESN364 on hot flash interference on daily life in terms of changes from baseline over time in HFRDIS;
    -effect of 12-week administration of ESN364 on climacteric symptoms in terms of changes from baseline over time in LSEQ, GCS, and SDS;
    -effect of 12-week administration of ESN364 on body composition assessed by DEXA;
    -effect of 12-week administration of ESN364 on sex hormone plasma conc and SHBG;
    -effect of 12-week administration of ESN364 on exploratory hormone plasma conc.
    -safety and tolerability of 12-w administration of ESN364 in terms of AEs, physical examination, vital signs, ECG, clinical laboratory safety, and BALP conc.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women, between 40 and 65 years old (extremes included) at screening;
    2. Spontaneous amenorrhea for at least 12 consecutive months; or spontaneous amenorrhea for at least 6 months with biochemical criteria of menopause (FSH >40 IU/L); or spontaneous amenorrhea for at least 3 months with biochemical/physical criteria of menopause (FSH >40 IU/L and E2 <0.21 nmol/L); or having had bilateral oophorectomy at least 6 weeks prior to screening (with or without hysterectomy);
    3. At least 49 moderate or severe hot flashes or night sweats over a period of 7 consecutive days, as recorded in the daily diary during the screening period, with at least 4 of those days with 7 or more moderate or severe hot flashes per day;
    4. In good general health as determined on the basis of medical history and general physical examination performed at screening; Hematology and chemistry parameters, pulse rate and/or blood pressure, and ECG within the reference range for the population studied, or showing no clinically relevant deviations, as judged by the Investigator;
    5. Negative urine test for selected drugs of abuse (amphetamines, tricyclic antidepressants, cannabinoids, cocaine, tetrahydrocannabinol, or opiates) at screening;
    6. Negative serology panel (including hepatitis B surface antigen [HBsAg], anti-hepatitis C virus [HCV] and human immunodeficiency virus (HIV) antibody screens);
    7. Negative urine pregnancy test at screening;
    8. Informed Consent Form (ICF) signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
    E.4Principal exclusion criteria
    1. Use of a prohibited therapy or not willing to wash-out drugs as mentioned in the prohibited therapies section (Section 6.2);
    2. History (in the past year) or presence of drug or alcohol abuse;
    3. Suicide attempt in the past 3 years;
    4. Previous or current history of a malignant tumor (except basal cell carcinoma);
    5. Active liver disease or jaundice, or out-of-range values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST); or total bilirubin >1.3 times the upper limit of normal (ULN); or creatinine >1.5 times the ULN; or estimated glomerular filtration rate (eGFR) using the
    Modification of Diet in Renal Disease (MDRD) formula <60 mL/min/1.73 m2 at screening;
    6. Medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], or endocrine disease) or malignancy that could confound interpretation of the study outcome, as judged by the Investigator;
    7. Any psychological disorder according to the criteria indicated in the Diagnostics and Statistical Manual of Mental Disorders (DSM, 4th edition) within one year prior to screening. Such disorders include but are not limited to current major depression, alcohol (more than 3 glasses of wine, beer, or equivalent/day) or substance abuse/dependence;
    8. Judged by the Investigator to be unsuited to participate in the study, based on findings observed during physical examination, vital sign assessment, or 12-lead ECG;
    9. History of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients;
    10. Presence or sequellae of gastrointestinal, liver, kidney or other conditions known to interfere with the ADME mechanisms of drugs, as judged by the Investigator;
    11. Concurrent participation in another interventional study (or participation within 3 months prior to screening in this study);
    12. History of poor compliance in clinical studies;
    13. Unable or unwilling to complete the study procedures;
    14. Subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof who is directly involved in the conduct of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics:
    Assessment of plasma ESN364 concentrations will be exploratory.

    Efficacy:
    Change from baseline to Week 12 in weekly Hot Flash Score
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the trial
    E.5.2Secondary end point(s)
    Efficacy:
    Secondary endpoints:
    - Changes from baseline over time in weekly Hot Flash Score and Hot Flash Frequency;
    - Change from baseline over time in HFRDIS score;
    - Changes from baseline over time in LSEQ, GCS, and SDS.
    Exploratory endpoint: the change from baseline to Week 12 in body composition (lean mass, fat mass, bone mass/density) will be explored

    Pharmacokinetics:
    Assessment of plasma ESN364 concentrations will be exploratory.

    Pharmacodynamics:
    Changes in plasma concentrations of LH, FSH, E2, SHBG, leptin, insulin, C-peptide, and HBA1c from baseline over time will be evaluated.

    Safety
    - AE frequency and severity from first dose of study drug through the last visit;
    - Changes from baseline over time in hematology and biochemistry concentrations;
    - Changes from baseline over time in vital sign and ECG assessments;
    - Changes from baseline over time in BALP and CTX levels.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the trial
    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 Yes
    E.8.1.7.1Other trial design description
    proof of concept
    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 concerned5
    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 years0
    E.8.9.1In the Member State concerned months5
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state80
    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)
    see protocol
    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 Decision2015-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
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