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    Summary
    EudraCT Number:2006-004890-93
    Sponsor's Protocol Code Number:E2020-G000-328
    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:2008-05-14
    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 number2006-004890-93
    A.3Full title of the trial
    E2020-G000-328 Open Label Extension Study of 23mg Donepezil SR in Patients with Moderate to Severe Alzheimer's Disease.
    A.4.1Sponsor's protocol code numberE2020-G000-328
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameDonepezil Hydrochloride SR
    D.3.2Product code BNAG SR
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNdonepezil hydrochloride
    D.3.9.2Current sponsor codeE2020
    D.3.9.3Other descriptive name(RS) - 1-benzyl-4-((5,6-dimethoxy-1-indanon)-2-yl)-methylchloride (IUPAC)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number23
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the safety and efficacy of long-term administration of 23 mg donepezil SR in patients with moderate to severe Alzheimer’s disease.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Patients

    1) Written informed consent will be obtained from the patient (if possible) or from the patient’s legal guardian or other representative at the time of the Baseline visit, prior to beginning any assessments or activities. Even if unable to provide written informed consent, the patient must assent verbally to participating in the study and the record should note this assent.

    2) Completion of study E2020-G000-326, including the SIB and the ADCS-ADL
    at the Final Visit. Refusal of patients to take either of these tests will disqualify them from entry into study E2020-G000-328.

    3) There must be no ongoing SAEs or history of serious adverse drug reactions during study E2020-G000-326 in its entirety.

    4) Patients must enroll in the present study within 3 days of completion of study
    E2020-G000-326.

    5) Health: physically healthy and ambulatory or ambulatory-aided (i.e., walker or cane); corrected vision and hearing sufficient for compliance with testing procedures.

    6) Co-morbid medical conditions must be well-controlled as determined by the
    investigator.

    7) Patients undergoing treatment with selective serotonin reuptake inhibitors (SSRIs) at doses that are less than or equal to the approved dose range of therapeutic efficacy as specified in the Physician’s Desk Reference or equivalent may enter the study.

    8) Concomitant Medications: Patients undergoing treatment with the following
    medications may be enrolled in the study provided the following conditions are met.

    a. Chronic daily benzodiazepine use may be allowed if doses are stable within an approved dose range consistent with currently accepted standards of practice, to be confirmed by Medical Monitor. Chronic intermittent use of benzodiazepines may be allowed pending consultation and approval by the Medical Monitor but not within 48 hours of scheduled assessment.

    b. Bronchodilator medications for treatment of COPD may be allowed as long as
    drug is administered via metered dose inhaler within approved dose range.

    c. Memantine is allowed if taken at doses of 20 mg/day or less (as specified in
    the Physician’s Desk Reference or equivalent), provided that the dose is stable.

    9) The patient must have a relative/caregiver who supervises the regular taking of the drug at the correct dose and is alert for possible side effects, unless the patient’s legal guardian takes on this task


    Inclusion Criteria for Caregivers
    Written informed consent will be obtained from the designated caregiver for participation in study assessments. The caregiver must be sufficiently familiar with the patient (as determined by the investigator) to provide accurate data. Specifically, the caregiver must have sufficient contact with the patient to provide accurate reports of the patient’s functioning, must be able to observe for possible adverse events, and must be able to accompany the patient to all visits. It is preferable that the caregiver be the same as in study E2020-G000-326. If no replacement caregiver is available who meets the caregiver inclusion/exclusion criteria, the patient must be discontinued from the study.
    E.4Principal exclusion criteria
    Exclusion Criteria for Patients

    1) No caregiver available to meet the inclusion criteria for caregivers.

    2) Patients with any active or clinically-significant conditions affecting
    absorption, distribution, or metabolism of the study medication (e.g., inflammatory
    bowel disease, gastric or duodenal ulcers, hepatic disease, or severe lactose
    intolerance).

    3) Known plan for elective surgery during the study period that would require
    general anesthesia and administration of neuromuscular blocking agents, such as
    succinylcholine, to induce paralysis/muscle relaxation. Minor surgery, such as
    colonoscopy or cataract surgery, will be permitted as long as it does not require the
    use of these paralytic agents.

    4) Patients who are unwilling or unable to fulfill the requirements of the study.

    5) Use of any prohibited prior or concomitant medications as described in
    Section 10.7 and listed in Appendix 4 of the Protocol.

    6) Any condition that would make the patient, in the opinion of the investigator,
    unsuitable for the study.

    7) Patients taking concomitant antidepressant medication known to have
    significant anticholinergic effects, such as tricyclic antidepressants prescribed at doses recommended for the treatment of major depression. Prohibited antidepressants are described in section 10.7 and listed in Appendix 4 of the Protocol.

    8) Patients who cannot swallow or who have difficulty swallowing whole tablets.

    9) Patients taking any alternative medication such as vitamins and/or herbal products or alternative medical techniques such as acupuncture or acupressure specifically for the treatment of AD are not eligible.


    Exclusion Criteria for Caregivers
    1) Caregivers who are unwilling or unable to give informed consent or otherwise to
    fulfill the requirements of the study.

    2) Any condition that would make the caregiver, in the opinion of the Investigator,
    unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Assessments:
    Sever Impairment Battery (SIB) (cognitive function of patient), Mini Mental State Examination (MMSE) cognitive function of patient, Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) functional capabilities of patient, Quality of Life -Alzheimer's Disease (QoL-AD), and EuroQoL -5 Dimension (EQ-5D) quality of life, Screen for Caregiver Burden (SCB) non professional caregiver burden, Treatment Outcome Scale (TOS) treatment outcomes, Goal Attainment Scale (GAtS) caregiver and patient treatment goals.

    Safety Assessments:
    Vital signs, weight, complete physical examination, complete or basic neurological examination, 12-lead ECG, clinical laboratory screens of blood and urine, adverse event monitoring.
    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 No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    End of trial is defined as "Database Lock".

    Investigator and site information access is required after last patient last visit and until database lock (resolution of queries to enable database lock).
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Alzheimer's disease patients may be unable to provide written informed consent therefore patient must assent verbally. Written consent is required from the patients legal guardian/representative the record will note this assent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 650
    F.4.2.2In the whole clinical trial 1450
    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)
    Eisai may provide continued treatment with the investigational product in line with its Compassionate Use Extended Access Program at the end of the open-label extension study. This program provides patients with serious or life-threatening diseases, who have previously completed a clinical trial with an Eisai investigational product, an opportunity to have continued access to this investigational product until final marketing approval is received and the commercial product is available.
    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 Decision2008-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-01
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