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    Summary
    EudraCT Number:2012-003228-19
    Sponsor's Protocol Code Number:EVP-6124-017
    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:2014-01-10
    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 number2012-003228-19
    A.3Full title of the trial
    A Multicenter 26-Week Extension Study to Evaluate the Safety and Clinical Effects of Prolonged Exposure to 1 and 2 mg Doses of EVP-6124, an Alpha- 7 Nicotinic Acetylcholine Receptor Agonist, as an Adjunctive Pro-cognitive Treatment in Subjects with Schizophrenia on Chronic Stable Atypical Antipsychotic Therapy
    Estudio de Extensión, Multicéntrico de 26 semanas, para evaluar la Seguridad y Efecto Clínico de la Exposición Prolongada a dosis de 1 y 2 mg de EVP-6124, un Agonista del Receptor Nicotínico de Acetilcolina Alfa-7 como Tratamiento Adyuvante Pro-Cognitivo en Sujetos con Esquizofrenia en Tratamiento Crónico Estable con Antipsicóticos Atípicos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To assess the long-term safety of EVP-6124 in Schizophrenia subjects.
    Evaluar la seguridad a largo plazo de EVP-6124 en sujetos con Esquizofrenia
    A.4.1Sponsor's protocol code numberEVP-6124-017
    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 SponsorEnVivo 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 supportEnVivo Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINC Research
    B.5.2Functional name of contact pointRegulatory Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressRiver View, The Meadows Business Park, Station Approach, Blackwater
    B.5.3.2Town/ cityCamberley, Surrey
    B.5.3.3Post codeGU17 9AB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441276481000
    B.5.5Fax number+44127635743
    B.5.6E-mailSM_Regaffairs_eu_ap@incresearch.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
    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 number1
    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
    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.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
    Cognitive impairment associated with schizophrenia
    Deficiencia cognitiva asociada a esquizofrenia
    E.1.1.1Medical condition in easily understood language
    Disorder that affects the ability to think, concentrate, formulate ideas, reason and remember and is associated with schizophrenia
    Desorden que afecta a la capacidad de pensar, concentrarse, formular ideas, razonar y recordar y está asociado con la esquizofrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10009846
    E.1.2Term Cognitive impairment
    E.1.2System Organ Class 100000004852
    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 long-term safety of 1 and 2 mg doses of EVP-6124 tablets administered once daily for up to 52 weeks in subjects who received EVP-6124 in both the pivotal and extension studies and up to 26 weeks in subjects who were randomized from placebo to EVP-6124 upon entry into this extension study.
    Evaluar la seguridad a largo plazo de comprimidos de EVP-6124 en dosis de 1 y 2 mg administradas una vez al día, por un máximo de 52 semanas en sujetos que recibieron EVP-6124 en los estudios principal y de extensión y hasta 26 semanas en sujetos que fueron aleatorizados desde el placebo hasta el EVP-6124 al ingresar en este estudio de extensión
    E.2.2Secondary objectives of the trial
    To assess the extended clinical effects of 1 and 2 mg doses of EVP-6124 tablets administered once daily for up to 26 weeks. Clinical effects assessments will include Clinical Global Impression (CGI) ? Severity (CGI-S) and Change (CGI-C) scales, quality of life using the EuroQol-5D? (EQ-5D-5L), and healthcare resource utilization using the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRIEU).
    Evaluar los efectos clínicos extendidos de las dosis de 1 y 2 mg de los comprimidos de EVP-6124 administrados una vez al día por un máximo de 26 semanas. Las evaluaciones de los efectos clínicos incluirán Impresión clínica global (CGI) ? Escala de gravedad (CGI-S) y Escala de cambio (CGI-C), calidad de vida utilizando el cuestionario EuroQol5D? (EQ 5D 5L) y uso de los recursos médicos a través del Inventario socio-demográfico y de recepción de servicios por el paciente ? Versión europea (CSSRI-EU)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completion of the Day 182 visit in a previous 26-week double-blind study (EVP-6124-015 or EVP-6124-016).
    2. Subject has signed informed consent for this extension study, indicating that the subject understands the purpose of and procedures required for the study, before the initiation of any extension study specific procedures. Subjects who are unable to provide informed consent will not be included in the study.
    3. No clinically significant changes in the subject's medical status during participation in EVP-6124-015 or EVP-6124-016. Any significant changes in health care status and their impact on subject eligibility will be reviewed by the investigator and sponsor on a case-by-case basis.
    4. In the opinion of the investigator, the 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. Females and the female partners of males must be surgically sterile (hysterectomy or 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 one barrier method]). Female subjects must have a negative urine pregnancy test predose on Day 1.
    1. Cumplimiento de la visita del Día 182 en un estudio a doble ciego de 26 semanas anterior (EVP-6124-015 o EVP-6124-016).
    2. El sujeto ha firmado el consentimiento informado para este estudio de extensión, indicando que el sujeto entiende el fin y los procedimientos necesarios para el estudio, antes de la iniciación de cualquier procedimiento específico del estudio de extensión. Los sujetos que no puedan proveer el consentimiento informado no se incluirán en el estudio.
    3. No se presentaron cambios clínicamente significativos en el estado de salud del sujeto durante la participación en EVP-6124-015 o EVP-6124-016. Cualquier cambio significativo en el estado de atención médica y su impacto en la elegibilidad del sujeto será revisado por el investigador y el promotor según cada caso en particular.
    4. De acuerdo con la opinión del investigador, el tratamiento de extensión es lo más conveniente para el sujeto.
    5. Los sujetos sexualmente activos, fértiles (hombres y mujeres) deben usar un método anticonceptivo eficaz durante el estudio. Las participantes y la pareja de sexo femenino de un sujeto masculino deben ser quirúrgicamente estériles (histerectomía o ligadura de trompas bilateral), deben haber tenido la menopausia durante por lo menos 1 año o deben estar dispuestas a utilizar métodos anticonceptivos adecuados si tienen capacidad de concebir (definido como el uso sistemático de métodos anticonceptivos eficaces combinados [incluido al menos 1 método de barrera]). Las participantes deben tener una prueba de embarazo en orina negativa antes de la dosis el Día 1.
    E.4Principal exclusion criteria
    1. Significant risk for suicidal or violent behavior, as determined by the investigator. Significant risk for suicidal behavior is defined as 1) suicidal ideation as endorsed on items 4 and 5 of the C-SSRS; 2) suicidal behaviors detected by the C-SSRS; or 3) psychiatric interview and examination.
    2. Adverse events from the previous study (EVP-6124-015 or EVP-6124-016) that have not resolved, are of moderate or greater severity, and judged to be possibly related or related to study drug and are thought by
    the investigator to be contraindications to study participation.
    3. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
    4. Female subjects who are pregnant.
    5. Subjects who received any other investigational treatment during participation in either EVP-6124-015 or EVP-6124-016 other than assigned study medication.
    1. Riesgo significativo de comportamiento violento o suicida, según lo determine el investigador. El riesgo significativo de comportamiento suicida se define como: 1) ideación suicida respaldada por los puntos 4 y 5 de la Escala de Columbia para evaluar el riesgo de suicidio (C-SSRS); 2) comportamientos suicidas detectados por la C-SSRS; o 3) entrevista psiquiátrica y examen.
    2. Acontecimientos adversos del estudio anterior (EVP-6124-015 o EVP-6124-016) que no se han resuelto, sean de gravedad moderada o severa, se consideren posiblemente relacionados o relacionados con el fármaco del estudio, y el investigador opine que sean contraindicaciones para la participación en el estudio.
    3. Cualquier afección que haría que el sujeto, según la opinión del investigador, no sea adecuado para el estudio.
    4. Participantes embarazadas.
    5. Sujetos que recibieron cualquier otro tratamiento en investigación durante la participación en EVP-6124-015 o EVP-6124-016, que no sea el medicamento del estudio asignado.
    E.5 End points
    E.5.1Primary end point(s)
    The safety analysis is intended to describe the safety and tolerability of each dose of EVP-6124 (1 and 2 mg). The assessment of safety will be based primarily on the following assessments: AEs, clinical laboratory tests, vital signs measurements, ECGs, SAS, CDSS, C-SSRS, and directed physical examinations. All safety data will be analyzed descriptively.
    El análisis de seguridad pretende describir la seguridad y la tolerabilidad de cada dosis de EVP-6124 (1 y 2 mg). La evaluación de la seguridad se basará principalmente en las siguientes evaluaciones: AA, análisis de laboratorio clínico, mediciones de signos vitales, ECG, SAS, CDSS, C-SSRS y exámenes físicos dirigidos. Todos los datos de seguridad se analizarán en forma descriptiva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at each study visit
    en cada visita del estudio
    E.5.2Secondary end point(s)
    Clinical efficacy will be evaluated by the CGI-S, CGI-C, EQ-5D and the CSSRI-EU. Descriptive statistics to assess the change from baseline will be provided for each clinical effects variable by dose group and overall at each visit.
    La eficacia clínica será evaluada a través de CGI-S, CGI-C, EQ-5D y CSSRI-EU. Las estadísticas descriptivas para evaluar cambios desde el inicio será proporcionadas para cada efecto clínico variable por grupo de dosis y en general en cada visita.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All efficacy assessments will be performed on one or more of the following study visits Days 1, 56, 112, and 182/ET.
    Todas las evaluaciones de eficacia serán llevadas a cabo en una o más de las visitas del estudio de los días 1, 56, 112, y 182/FP
    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    2 different doses
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Italy
    Netherlands
    Romania
    Argentina
    Australia
    Colombia
    Germany
    Spain
    Mexico
    Poland
    Russian Federation
    Serbia
    Singapore
    Ukraine
    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
    LVLS
    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 months0
    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 months0
    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: 1050
    F.1.3Elderly (>=65 years) No
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 310
    F.4.2.2In the whole clinical trial 1050
    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)
    The subjects will continue on their standard of care treatment based on the judgment of their treating physician.
    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 Decision2014-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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