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    Summary
    EudraCT Number:2012-005524-15
    Sponsor's Protocol Code Number:ELND005-AG251
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-06-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-005524-15
    A.3Full title of the trial
    A 12-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease.
    Estudio de extensión de 12 semanas para evaluar la seguridad de ELND005 oral para el tratamiento de la agitación y la agresividad en pacientes con enfermedad de Alzheimer moderada o grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-Week Safety Extension Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease.
    Estudio de extensión de 12 semanas para evaluar la seguridad de ELND005 oral para el tratamiento de la agitación y la agresividad en pacientes con enfermedad de Alzheimer moderada o grave
    A.4.1Sponsor's protocol code numberELND005-AG251
    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 SponsorElan Pharma International Ltd
    B.1.3.4CountryIreland
    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 supportElan Pharma International Ltd
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointGlobal Project Management
    B.5.3 Address:
    B.5.3.1Street Address7551 Metro Center Drive
    B.5.3.2Town/ cityAustin
    B.5.3.3Post codeTX 7874
    B.5.3.4CountryUnited States
    B.5.4Telephone number001512550 4115
    B.5.5Fax number001512685 9406
    B.5.6E-mailELND005-AG251SM@ppdi.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 nameScyllo-inositol
    D.3.2Product code ELND005
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNscyllo-inositol
    D.3.9.1CAS number 488-59-5
    D.3.9.2Current sponsor codeELND005
    D.3.9.3Other descriptive nameEscilitol, Cocositol, Quercinitol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 placeboFilm-coated tablet
    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
    Agitation and Aggression in Moderate to severe Alzheimer's Disease.
    Agitación y agresividad en pacientes con enfermedad de Alzheimer de moderada a grave
    E.1.1.1Medical condition in easily understood language
    Agitation and Aggression in Patients with Alzheimer's Disease.
    Agitación y agresividad en pacientes con enfermedad de Alzheimer.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    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 safety and tolerability of ELND005 treatment with up to 24 weeks exposure, in Moderate to Severe Alzheimer's Disease patients with agitation and aggression.
    To evaluate the effects and persistence of effects of ELND005 on agitation and aggression and other assesments including neuropsychiatric symptons, cognitive status, patient's dependence status and caregiver distress.
    Evaluar la seguridad y la tolerabilidad del tratamiento con ELND005 durante una exposición máxima de 24 semanas en pacientes con EA de moderada a grave con agitación y agresividad.
    Evaluar los efectos y la persistencia de los efectos de ELND005 sobre la agitación y agresividad y las demás evaluaciones incluyendo síntomas neuropsiquiátricos, estado cognitivo, estado de dependencia del paciente y angustia del cuidador.
    E.2.2Secondary objectives of the trial
    To evaluate additional efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) endpoints.
    Evaluar criterios adicionales de valoración de la eficacia, farmacocinética (PK) y farmacodinámia (FD).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed and dated written informed consent obtained in accordance with local regulations.
    - Completes the Week 12 visit in study AG201 while taking their assigned does of study drug.
    - Has no new medical condtraindication to continue participation in the study
    - Consentimiento informado por escrito firmado y fechado, obtenido de conformidad con las normas locales.
    - Completa la visita de la semana 12 del estudio AG201 mientras toma la dosis asignada del fármaco del estudio.
    - No tiene contraindicaciones médicas nuevas para seguir participando en el estudio.
    E.4Principal exclusion criteria
    -Is currently using any other investigational or experimental drugs or devices.
    - Has significant worsening of medical conditions or dementia such that it may preclude completion of this safety extension study.
    - Está utilizando actualmente cualquier otro fármaco o dispositivo experimental o en investigación.
    - Presenta un empeoramiento significativo de sus trastornos médicos o demencia que podría impedir que finalizara este estudio de extensión de la seguridad.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints:
    -Incident and severity of treatment-emergent AEs, serious AEs, and withdrawls due to AEs.

    -Changes in Baseline of Study AG201 to Week 12 of Study AG251 in the following safety assesments: vital sign measurments, weight, clinical laboratory assessments, physical and neurological examinations, and ECGs.
    Criterios de valoración de la seguridad:

    - Incidencia e intensidad de los AA aparecidos con el tratamiento (AAAT), AA graves (AAG) y retiradas por AA.
    - Variaciones entre el momento basal del estudio AG201 y la semana 12 del estudio AG251 de las siguientes evaluaciones de la seguridad: determinaciones de constantes vitales, peso, evaluaciones analíticas, exploraciones físicas y neurológicas y ECG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    Efficacy endpoints:
    Changes in baseline to Week 12 in Study AG251 (for all patients), and changes from baseline in Study AG201 to Week 12 of Study AG251 (for patients in Group 1) in:
    -NPI-C combined agitation and aggression subscores
    -mADCS-CGIC agitation domain scores (CGIC)
    -NPI-C subitems of agitation, aggression, apathy, depression/dysphoria, anxiety.
    -NPI subitems of aberrant motor behaviour, nighttime behavior, disinhibition, delusions and hallucinations.
    -Total NPI score.

    PK/PD Assessments/Endpoints
    Relationship between PK parmaeters and selected safety, efficacy, and PD outcome measures.
    Criterios de valoración de la eficacia:
    - Variaciones entre el momento basal y la semana 12 del estudio AG251 (en todos los pacientes) y variaciones entre el momento basal del estudio AG201 y la semana 12 del estudio AG251 (en los pacientes del grupo 1) de:
    - Subpuntuaciones de agitación y agresividad de la escala NPI C .
    - Puntuación de dominio de agitación de la escala mADCS CGIC
    - Subpuntuación de agitación, agresividad, apatía, depresión/disforia, ansiedad de la escala NPI C.
    - Subapartados de conducta motriz aberrante, conducta nocturna, desinhibición, ideas delirantes y alucinaciones de la escala NPI.
    - Puntuación total en la escala NPI.

    Evaluación/Criterios de valoración de FC/FD
    Relación entre los parámetros de FC y las medidas resultantes seleccionadas de la seguridad, eficacia y FD.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Canada
    France
    Spain
    United Kingdom
    United States
    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
    A study patient will be considered to have completed Study AG251 at the end of the 12 weeks of treatment (ie, Week 12 or End of Study [EOS]).

    This definition is based on the timepoint for primary endpoint assessment. A safety follow-up phase of 6 weeks will occur following the Week 12 or End of Study [EOS] visit.
    Se considerará que un paciente ha finalizado el estudio AG251 al concluir las 12 semanas de tratamiento (es decir, semana 12 o final del estudio [FDE]).

    Esta definición se basa en los tiempos de valoración de los criterios de valoración primarios. Después de la Semana 12 o de la visita de final del estudio tendrá lugar una fase de seguimiento de seguridad de 6 semanas
    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 months1
    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 months1
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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
    Allowing for a patient's legally authorised representative to provide informed consent with the patient's assent, if the patient is deemed not competent to provide informed consent.
    En el caso de que el paciente no sea competente para dar su
    consentimiento informado, permitir que el representante legal
    autorizado dé el consentimiento informado cuando el paciente acceda.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 400
    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
    Ninguno
    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 Decision2013-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-08-18
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