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    Summary
    EudraCT Number:2013-002654-75
    Sponsor's Protocol Code Number:EVP-6124-026
    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:2014-06-05
    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 number2013-002654-75
    A.3Full title of the trial
    A 26-Week Extension Study of the Safety and Clinical Effects of EVP-6124 in Subjects with Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication
    Ensayo de extensión de 26 semanas de la seguridad y efectos clínicos de EVP-6124 en pacientes con enfermedad de Alzheimer que estén recibiendo o hayan recibido anteriormente tratamiento con un medicamento inhibidor de la acetilcolinesterasa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the safety and effectiveness of investigational study drug EVP-6124 in subjects with Alzheimer's Disease
    Ensayo de la seguridad y efectividad de EVP-6124 en pacientes con enfermedad de Alzheimer
    A.4.1Sponsor's protocol code numberEVP-6124-026
    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 SponsorForum Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    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 supportForum Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationinVentiv Health Clinical UK Ltd
    B.5.2Functional name of contact pointFranz Buchholzer
    B.5.3 Address:
    B.5.3.1Street AddressThames House, 17 Marlow Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 7AA
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailRegopseurope@inventivhealth.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 nameEVP-6124
    D.3.2Product code EVP-6124
    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 INNEVP-6124
    D.3.9.1CAS number 1350343-61-1
    D.3.9.2Current sponsor codeEVP-6124 HCl Monohydrate
    D.3.9.3Other descriptive nameEVP-6124 HCL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB31361
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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 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 nameEVP-6124
    D.3.2Product code EVP-6124
    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 INNEVP-6124
    D.3.9.1CAS number 1350343-61-1
    D.3.9.2Current sponsor codeEVP-6124 HCl Monohydrate
    D.3.9.3Other descriptive nameEVP-6124 HCL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB31361
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer?s Disease
    Enfermedad de Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer?s Disease
    Enfermedad de Alzheimer
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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
    To assess the safety of 2 fixed doses of EVP-6124 (2 or 3 mg daily) for up to 52 weeks in subjects with Alzheimer?s disease (AD) who complete (Day 182) studies EVP-6124-024 or EVP-6124-025
    Los objetivos principales son evaluar la seguridad de 2 dosis fijas de EVP-6124 (2 o 3 mg al día) hasta durante 52 semanas en pacientes con Enfermedad de Alzheimer (EA) que concluyan (día 182) los ensayos EVP-6124-024 o EVP-6124-025.
    E.2.2Secondary objectives of the trial
    To assess the duration of clinical effects of EVP-6124 for up to 52 weeks on the following endpoints:
    ? Cognition using the Mini-Mental State Examination (MMSE)
    ? Psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI)
    ? Quality of life using the EuroQol-5D? (EQ-5D), pharmacoeconomic outcomes using the Resource Utilization in Dementia (RUD-Lite© 3.3), and caregiver perceived burden using the Zarit Burden Interview (ZBI)
    Los objetivos secundarios son evaluar la duración de los efectos clínicos de EVP-6124 hasta durante 52 semanas en los siguientes criterios de valoración:
    - Cognición mediante el Examen mental abreviado (Mini-Mental State Examination, MMSE)
    - Síntomas psiquiátricos y conductuales mediante el Inventario Neuropsiquiátrico (Neuropsychiatric Inventory, NPI)
    - Calidad de vida utilizando el cuestionario EuroQol-5D? (EQ-5D), los resultados farmacoeconómicos mediante el Cuestionario sobre la utilización de recursos en la demencia (Resource Utilization in Dementia, RUD-Lite© 3.3) y la sobrecarga percibida por el cuidador utilizando el Cuestionario sobre la carga del/de la cuidador/a de Zarit (Zarit Burden Interview, ZBI)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent form (ICF) for this extension study signed by the subject or legally acceptable representative and an ICF signed by the support person/caregiver before initiation of any study-specific extension procedures
    2. Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025
    3. No clinically significant change in the judgment of the investigator in the subject?s medical status during study EVP-6124-024 or EVP-6124-025
    4. In the judgment of the investigator, extension treatment is in the best interest of the subject
    5. Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or Protocol EVP-6124-026; 12 September 2013 Page 9 of 66 Forum Pharmaceuticals Inc. CONFIDENTIAL EVP-6124 bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method])
    6. Reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible
    1. Formulario de consentimiento informado (FCI) para este ensayo de extensión firmado por el paciente o su representante legalmente autorizado y un FCI firmado por la persona de apoyo o el cuidador antes del comienzo de cualquier procedimiento específico del ensayo
    2. Conclusión con éxito (día 182) del ensayo EVP-6124-024 o del ensayo EVP-6124-025
    3. Ningún cambio clínicamente significativo, en opinión del investigador, en el estado médico del paciente durante el ensayo EVP-6124-024 o el ensayo EVP-6124-025
    4. El tratamiento de la extensión es, a juicio del investigador, lo mejor para el paciente
    5. Los pacientes (varones y mujeres) fértiles sexualmente activos deberán utilizar durante el ensayo un método anticonceptivo efectivo. Si son potencialmente fértiles, las pacientes y las parejas de sexo femenino de los pacientes varones deberán haberse sometido a una esterilización quirúrgica (histerectomía o ligadura bilateral de trompas) o ser posmenopáusicas desde al menos 1 año antes, o bien estar dispuestas a utilizar métodos anticonceptivos adecuados (definidos como el uso de una combinación de métodos anticonceptivos efectivos [que incluya al menos 1 método de barrera])
    6. Una persona de apoyo o un cuidador fiable y capacitado, que, si no vive en el mismo domicilio, interaccione con el paciente aproximadamente 4 veces por semana y se encuentre disponible para asistir personalmente a las visitas al centro cuando sea posible
    E.4Principal exclusion criteria
    1. Significant risk of suicidal or violent behavior in the judgment of the investigator
    2. Adverse events (AEs) from the previous study (EVP-6124-024 or EVP-6124-025) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation
    3. Any condition that would make the subject in the judgment of the investigator unsuitable for the study
    4. Female subjects who are pregnant, nursing, or planning to become pregnant during the extension study
    1. Riesgo significativo, a juicio del investigador, de conductas suicidas o violentas
    2. Reacciones adversas del ensayo anterior (EVP-6124-024 o EVP-6124-025) que no se hayan resuelto, que sean moderadas o intensas, que se evalúen como posiblemente relacionadas o relacionadas con el fármaco del ensayo y que el investigador considere que constituyen una contraindicación para la participación en el ensayo de extensión
    3. Todo estado que haga que el paciente, en opinión del investigador, no sea adecuado para el ensayo
    4. Pacientes que estén embarazadas o en período de lactancia o que pretendan quedarse embarazadas durante el ensayo de extensión
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoints for this study include the mean change from baseline to Day 182 in the Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory (NPI).
    Los criterios de valoración de eficacia primaria para este estudio incluyen el cambio medio desde el inicio hasta el día 182 en el Mini Examen del Estado Mental (MMSE) y el Inventario Neuropsiquiátrico (NPI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    (MMSE) : baseline (Extension Study Day 1) and Days 84 and 182 or early termination.
    (NPI): baseline (Extension Study Day 1) and Days 84 and 182 or early termination.
    (MMSE): basal (día 1 del estudio de extensión) y días 84 y 182 o finalización anticipada
    (NPI): basal (día 1 del estudio de extensión) y días 84 y 182 o finalización anticipada
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints for this study include the mean change from baseline to Day 182 in the Resource Utilization in Dementia (RUD-Lite© 3.3), Zarit Burden Interview (ZBI), EuroQol-5D (EQ-5D) and Geriatric Depression Scale (GDS).
    Las variables secundarias de eficacia de este estudio incluyen el cambio medio desde el inicio hasta el día 182 en el cuestionario sobre la utilización de recursos en la demencia (RUD-Lite © 3.3), cuestionario sobre la carga del/de la cuidador/a de Zaritla (ZBI), EuroQol-5D (EQ-5D) y la Escala de Depresión Geriátrica (GDS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Resource Utilization in Dementia (RUD-Lite© 3.3): baseline (Extension Study Day 1) and Days 84 and 182 or early termination.
    Zarit Burden Interview (ZBI): baseline (Extension Study Day 1) and Days 84 and 182 or early termination.
    EuroQol-5D (EQ-5D): baseline (Extension Study Day 1) and Days 84 and 182 or early termination.
    Geriatric Depression Scale (GDS): baseline (Extension Study Day 1) and Days 84 and 182 or early termination.
    Cuestionario sobre la utilización de recursos en la demencia (RUD-Lite © 3.3): basal (día 1 del estudio de extensión) y días 84 y 182 o finalización anticipada.
    Cuestionario sobre la carga del/de la cuidador/a de Zaritla (ZBI): basal (día 1 del estudio de extensión) y días 84 y 182 o finalización anticipada.
    EuroQol-5D (EQ-5D): basal (día 1 del estudio de extensión) y días 84 y 182 o finalización anticipada.
    Escala de Depresión Geriátrica (GDS): basal (día 1 del estudio de extensión) y días 84 y 182 o finalización anticipada.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    estudio de extensión
    extension study
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Argentina
    Australia
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Portugal
    South Africa
    Spain
    United Kingdom
    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
    LVLS
    Última visita del último paciente
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1422
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 469
    F.4.2.2In the whole clinical trial 1580
    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)
    Subjects who complete extension treatment will be contacted by telephone for a safety follow-up visit (Day 189) that will include as assessment of concomitant medications, AEs, and constipation and other GI-related events using a structured questionnaire.
    Additionally, subjects including those who prematurely discontinue will be contacted by telephone to assess any serious adverse event (SAE) experienced within 30 days after the last dose of EVP-6124.
    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 Decision2014-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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