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    Summary
    EudraCT Number:2007-002780-27
    Sponsor's Protocol Code Number:GAL-ALZ-3005
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-12-17
    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 ConcernedAustria - BASG
    A.2EudraCT number2007-002780-27
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-severe Alzheimer’s Disease
    A.4.1Sponsor's protocol code numberGAL-ALZ-3005
    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 SponsorJanssen Cilag International NV
    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 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 Yes
    D.2.1.1.1Trade name REMINYL 8mg prolonged-release capsules, hard (Reminyl retard 8 mg Kapseln)
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameGalantamine HBr
    D.3.2Product code R113675
    D.3.4Pharmaceutical form Capsule, hard
    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 INNGalantamine Hydrobromide
    D.3.9.1CAS number 1953-04-04
    D.3.9.2Current sponsor codeR113675
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8 mg
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name REMINYL 16mg prolonged-release capsules, hard (Reminyl retard 16 mg Kapseln)
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameGalantamine HBr
    D.3.2Product code R113675
    D.3.4Pharmaceutical form Capsule, hard
    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 INNGalantamine Hydrobromide
    D.3.9.1CAS number 1953-04-04
    D.3.9.2Current sponsor codeR113675
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16 mg
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name REMINYL 24mg prolonged-release capsules, hard (Reminyl retard 24 mg Kapseln)
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameGalantamine HBr
    D.3.2Product code R113675
    D.3.4Pharmaceutical form Capsule, hard
    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 INNGalantamine Hydrobromide
    D.3.9.1CAS number 1953-04-04
    D.3.9.2Current sponsor codeR113675
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24 mg
    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
    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
    Mild to moderately severe 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
    Overall objective
    The overall objective of this study is to evaluate the benefit-risk of long-term
    (over the course of 2 years) treatment with galantamine as compared with
    placebo in subjects with mild to moderately-severe AD.

    Primary efficacy objective
    • Compare galantamine with placebo in cognitive change from baseline
    to Month 24 as measured by the MMSE score

    Primary safety objective
    Compare the rate of mortality between subjects randomly assigned to receive
    galantamine or matching placebo over the course of 2 years.
    E.2.2Secondary objectives of the trial
    Secondary efficacy objectives
    • Compare galantamine with placebo in cognitive change from baseline
    at Month 6 as measured by the MMSE score
    • Compare galantamine with placebo in change from baseline over the
    course of 2 years in activities of daily living as measured by the
    Disability Assessment in Dementia (DAD)
    • Compare galantamine with placebo with respect to health care
    utilization over the course of 2 years as measured by the time to
    change in the level of accommodation using APAS-CarB
    • Compare galantamine with placebo over the course of 2 years as
    measured by a retrospective estimate of caregiver time spent with the
    subject over the previous 3 months using the APAS-CarB

    Secondary safety objective
    Compare the incidence of treatment emergent adverse events, including
    serious adverse events, between subjects randomly assigned to receive
    galantamine or matching placebo over the course of 2 years.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    NOTE:
    A pharmacogenomic blood sample (10 mL) will be collected from subjects who give separate written informed consent for this component of the study (where local
    regulations permit). Subject participation in pharmacogenomic research is optional.
    E.3Principal inclusion criteria
    FULL CRITERIA IN PROTOCOL

    • Outpatients (men or women), 45 to 90 years of age, inclusive
    • Women must be postmenopausal (for at least 1 year), surgically sterile, sexually abstinent or if sexually active be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. Women of childbearing potential must have a negative serum β-hCG or urine pregnancy test at screening and at times as deemed appropriate by
    the investigator.
    • Diagnosed with mild to moderately-severe, probable or possible AD established in accordance with the criteria defined by the NINCDS-ADRDA or DSM-IV. Subjects presenting with AD, with or without CVD may be enrolled.
    • A computed tomography (CT) or magnetic resonance imaging (MRI) of the head done since the onset of symptoms leading to the diagnosis of AD. If a CT scan or MRI has not been performed from the time the cognitive symptoms appeared until the subject is screened for this study, it will have to be performed for inclusion in the study.
    • An MMSE score of 10 to 26 inclusive, at screening (Visit 1)
    • Be living at home or in residential/nursing homes
    • Be living with or have regular and frequent visits from a responsible caregiver. The caregiver must supervise the regular administration of the study medication to the subject to improve compliance and avoid dosage errors, be willing to provide information about the subject, and prepared to accompany the subject for scheduled visit assessments for the full 2-year duration of the study. Note: There may be more than 1 caregiver. However, the same caregiver should assess the subject throughout the study whenever possible. Because of the long-term nature of the study, it is highly desirable that, apart from that of the caregiver, contact information be available for 1 or preferably 2 additional family members or friends, who are able and willing to provide information about the subject.
    • Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study in accordance with the requirements of the ethical review committee
    • Informed consent must also be given by the caregiver for their own participation in the study for the full 2-year period
    • The subject and caregiver (or their legally acceptable representative) must be able to speak, read, and write in the language of the tests being administered and must be able to complete all testing
    • To participate in the optional pharmacogenomic component of this study, subjects (or their legally acceptable representative) must have signed the informed consent form (ICF) for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study.
    • Willing to adhere to the prohibitions and restrictions specified in this
    protocol
    E.4Principal exclusion criteria
    FULL CRITERIA IN PROTOCOL

    Neurodegenerative disorders other than AD such as Parkinson's disease, Frontotemperal Dementia or Huntington's Disease.

    Conditions which may contribute to dementia.

    Subjects with the co-existing medical conditions such as ongoing diagnosis of untreated epilepsy, major depression, schizophrenia, or other current clinically significant psychiatric disease, severe or uncontrolled behavioral disturbances.

    Clinically significant cardiovascular disease.

    Received cholinergic agents for the treatment of dementia within 2 weeks prior to screening.

    History of drug or alcohol abuse within the last year.

    History of severe drug allergy or hypersensitivity; including recorded hypersensitivity to cholinesterase inhibitors and its excipients, cholinergic agonists or similar agents, or bromide.

    Have received an investigational drug or used an experimental medical
    device within the last 30 days before the planned start of treatment.

    Subjects who, in the opinion of the investigator, are otherwise unsuitable
    for a study of this type.

    Subjects will not be entered in any other clinical study while participating
    in this study unless approval of the sponsor has been given.

    Employees of the investigator/study center, with direct involvement in
    the proposed study/other studies under the direction of that investigator/study center, and family members of the employees or investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the change from baseline in the MMSE score at Month 24.
    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 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 Yes
    E.7.1.3.1Other trial type description
    Phase IIIb [Long-term (2-year) Treatment]
    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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The protocol inclusion criteria makes reference to subjects or their legally acceptable representatives who must have signed an informed consent document.
    F.3.3.7Others No
    F.3.3.7.1Details of other specific vulnerable populations
    NOTE on Age Span: Outpatients, men or women, 45 to 90 years of age
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 2000
    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 Decision2008-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-03-21
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