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    Summary
    EudraCT Number:2017-003728-64
    Sponsor's Protocol Code Number:E2027-G000-201
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-003728-64
    A.3Full title of the trial
    A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    E2027 for the treatment of Dementia With Lewy Bodies
    A.4.1Sponsor's protocol code numberE2027-G000-201
    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 SponsorEisai Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportEisai Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Ltd.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressMosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00448456761400
    B.5.5Fax number00448456761486
    B.5.6E-mailLMedInfo@eisai.net
    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 E2027
    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 INNNot Yet Assigned
    D.3.9.1CAS number 1630083-70-3
    D.3.9.2Current sponsor codeE2027 Maleate
    D.3.9.3Other descriptive nameE2027
    D.3.9.4EV Substance CodeSUB191555
    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
    Dementia With Lewy Bodies
    E.1.1.1Medical condition in easily understood language
    Dementia with Lewy bodies: A form of dementia with abnormal proteins (Lewy bodies) accumulating in the brain, and symptoms include impaired memory, concentration, visual hallucinations.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067889
    E.1.2Term Dementia with Lewy bodies
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1- To determine whether E2027 is superior to placebo on the cognitive endpoint of MoCA
    in subjects with DLB after 12 weeks of treatment
    2- To determine whether E2027 is superior to placebo on the global clinical endpoint of
    CIBIC-Plus after 12 weeks of treatment
    E.2.2Secondary objectives of the trial
    1: To determine whether E2027 is superior to placebo on the following
    secondary endpoints after 12 weeks of treatment:
    - Clinician Global Impression of Change in Dementia with Lewy Bodies
    (CGIC-DLB)
    - Cognitive Fluctuation Inventory (CFI)
    - Mini-Mental State Examination (MMSE)
    - Neuropsychiatric Inventory (NPI)
     To evaluate the safety and tolerability of E2027 in subjects with DLB
     To characterize the population pharmacokinetics (PPK) of E2027 in
    subjects with DLB, including evaluation of the effects of intrinsic and
    extrinsic factors on E2027 pharmacokinetics
    (PK)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age 50 to 85 years, inclusive at time of consent.
    2. Meet criteria for probable DLB (as defined by the 4th report of the DLB Consortium)
    (Appendix 1). Specific situations regarding the use the imaging are described below:
    a. have 1 core clinical feature only by the investigator and who did not have previous reports of
    DAT brain imaging scan, MIBG scan or polysomnography (PSG) will undertake DAT brain
    imaging scan or MIBG scan as organized by the investigator.
    b. have 2 or more core clinical features by the investigator but who are judged as having only
    1 core clinical feature by central reviewer and who did not have previous reports of DAT
    brain imaging scan, MIBG scan or PSG may undertake DAT brain imaging scan or MIBG
    scan after discussion with the sponsor medical monitor.
    c. have 2 or more core clinical features by the investigator and the central reviewer and who
    did not have previous reports of DAT brain imaging scan, MIBG scan or PSG may undertake DAT brain imaging scan or MIBG scan after discussion with the sponsor medical
    monitor if the investigator considers that imaging is necessary to confirm the diagnosis.
    3. MMSE >14 and <26 at Screening Visit.
    4. Has experienced visual hallucinations during the past 4 weeks before Screening Visit.
    5. If receiving AChEIs, must have been on a stable dose for at least 12 weeks before Screening
    Visit, with no plans for dose adjustment during the study. Treatment-naïve subjects can be
    entered into the study but there should be no plans to initiate treatment with AChEIs from
    Screening to the end of the study.
    6. If receiving memantine, must have been on a stable dose for at least
    12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naïve subjects can be
    entered into the study but there should be no plans to initiate treatment with memantine from Screening to the end of the study. (revised per Amendment 03)
    7.Must have an identified caregiver or informant who is willing and able to provide follow-up
    information on the subject throughout the course of the study. This person must, in the opinion of
    the investigator, not be suffering from cognitive impairment, be sufficiently familiar with the
    subject and spend sufficient time with the subject on a regular basis such that the caregiver or
    informant can reliably fulfill the study requirements and must provide separate written consent.
    The caregiver or informant should normally be residing with the subject. If the caregiver or
    informant is not residing with the subject, the investigator has to be satisfied that the subject can
    contact the caregiver or informant readily during the times when the caregiver or informant is not
    with the subject. As a guide the caregiver or informant should have contact with the subject on at
    least 4 days a week and each day for a total of at least 5 hours. If in doubt about whether a
    subject's care arrangements are suitable for inclusion, the investigator should discuss this with the
    medical monitor. At all visits caregivers or informants need to attend the visit in person along
    with the subject. If during the study, the designated caregiver or informant relinquishes his/her
    responsibilities as caregiver or informant, a replacement caregiver or informant who meets the
    criteria above and who has similar knowledge of the subject’s clinical status from Baseline
    throughout the Treatment Period must be found. If no such replacement caregiver or informant is
    available, the subject must be discontinued from the study.
    8. Provide written informed consent. If a subject lacks capacity to consent in the investigator's
    opinion, the subject's assent should be obtained, as required in accordance with local laws,
    regulations and customs, plus the written informed consent of a legal representative should be
    obtained (capacity to consent and definition of legal representative should be determined in
    accordance with applicable local laws and regulations).
    E.4Principal exclusion criteria
    1. Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the subject’s DLB, including any comorbidities detected by clinical assessment or MRI.
    2. History of transient ischemic attacks or stroke within 12 months of Screening.
    3. Modified Hachinski Ischemic Scale >4.
    4. Parkinsonian (extrapyramidal) features with Hoehn & Yahr stage IV or higher.
    5. Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V).
    6. GDS score >8.
    7. Evidence of other clinically significant lesions that suggest a dementia diagnosis other than DLB on brain MRI at Screening. All MRIs will be acquired using a standardized procedure that will
    be outlined in the Imaging Charter and Imaging Acquisition Guidelines (IAG) and will be read by an approved centralized reader.
    8. Other significant pathological findings on brain MRI at Screening, including but not limited to: any macrohemorrhage (greater than 10 mm at greatest diameter); an area of superficial siderosis; evidence of cerebral contusion, encephalomalacia, aneurysms, arteriovenous malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel or white matter disease; space occupying lesions; or brain tumors [however, lesions diagnosed as meningiomas or arachnoid cysts and less than or equal to 1 cm at their greatest diameter need not be exclusionary])
    9. Hypersensitivity to E2027 or any of the excipients.
    10. A prolonged corrected QT interval calculated using Fridericia’s formula (QTcF) as demonstrated by triplicate ECG at the Screening or Baseline Visit (ie, mean value >450 msec).
    11. Had symptomatic orthostatic hypotension or symptomatic orthostatic tachycardia which resulted in hospitalization or urgent medical review in hospital in the past 12 months before Screening.
    12. Has a “yes” answer to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening.
    13. Taking any of the prohibited medications or not meeting the requirements regarding stable doses of permitted medications.
    14. Participation in a clinical study involving any investigational drug/device for DLB within 6 months before Screening or any other investigational drug/device in the 8 weeks or 5 half-lives
    (whichever is longer) of the study medication before Screening unless it can be documented that the subject was in a placebo treatment arm.
    15. Females of childbearing potential.
    (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least 12 consecutive months, in the appropriate age group,
    and without other known or suspected cause] or have been sterilized surgically [ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]).
    16. For subjects who participate in the CSF substudy, the following exclusions apply:
    a. A bleeding disorder that is not under adequate control (including a plate count <50,000, international normalized ratio [INR] >1.5 or partial thromboplastin time [PTT] > upper limit
    of normal [ULN]).
    b. Any contraindications to LP (eg, lower spinal malformation on physical examination, local spinal infection or other abnormality, or obesity to the extent that it makes LP technically difficult).
    E.5 End points
    E.5.1Primary end point(s)
    1- Change from baseline in the MoCA total score at 12 weeks of treatment
    2- CIBIC-Plus scale at 12 weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
     CGIC-DLB scale at 12 weeks of treatment
     Change from baseline at 12 weeks of treatment in the following endpoints:
    o CFI score
    o MMSE total score
    o NPI total score, subscores and caregiver or informant distress score
     Safety and tolerability of E2027 as measured by (revised per
    Amendment 02):
    o Incidence of adverse events including severe AEs, serious AEs, AEs resulting in discontinuation
    o Incidence of orthostatic hypotension and orthostatic tachycardia
    o Incidence of markedly abnormal laboratory values and shifts from baseline of laboratory values
    o Incidence of abnormal ECG parameters and abnormal ECG findings
    o Incidence of suicidality based on C-SSRS
    o Changes from baseline in the total score of Unified Parkinson's Disease Rating Scale
    Part III: Motor Examination (UPDRS-III).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks for : (1) Change from baseline at 12 weeks of treatment in the following endpoints:
    o NPI total score, subscores and caregiver or informant distress score
    o MMSE total score
    o CFI score

    12 weeks for : (2) CGIC-DLB scale at 12 weeks of treatment

    Over the period of 12 weeks for : (3) Safety and tolerability of E2027
    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 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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Japan
    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
    The end of study is defined as the last subject completing the Follow-Up Visit.
    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 months8
    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 months8
    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: 87
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 173
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 260
    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 Decision2018-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-20
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