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    Summary
    EudraCT Number:2013-000208-41
    Sponsor's Protocol Code Number:TV1380-COA-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-12
    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 number2013-000208-41
    A.3Full title of the trial
    A 12-week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Once-Weekly Intra-Muscular Injections of TV-1380 (150 mg/week or 300 mg/week) as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
    Estudio de 12 semanas, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y la seguridad de una inyección intramuscular semanal de TV-1380 (150 mg/semana o 300 mg/semana) como tratamiento facilitador de la abstinencia en sujetos dependientes de la cocaína
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-week study in cocaine dependent subjects to evaluate safety and efficacy of a once-weekly intra-muscular injection of TV1380 (150mg/week or 300mg/per week) as a treatment to facilitate cocaine abstinence compared to placebo.
    Estudio de 12 semanas en sujetos dependientes de cocaína para evaluar la eficacia y la seguridad de una inyección intramuscular semanal de TV-1380 (150 mg/semana o 300 mg/semana) como tratamiento que facilite la abstinencia comparado con placebo.
    A.4.1Sponsor's protocol code numberTV1380-COA-201
    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 SponsorTeva Pharmaceutical Industries Ltd.
    B.1.3.4CountryIsrael
    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 supportTeva Pharmaceutical Industries Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressWaldeckerstrasse 7
    B.5.3.2Town/ cityMoerfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number000000000000000
    B.5.5Fax number0000000000000000
    B.5.6E-mailInfo-era-clinical@teva.de
    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 nameAlbuBChE
    D.3.2Product code TV-1380
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeTV-1380
    D.3.9.3Other descriptive nameAlbuBChE, proteína de fusión entre el dominio catalítico de la butirilcolinesterasa con la albúmina humana
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
    Tratamiento facilitador de la abstinencia en sujetos dependientes de la cocaína
    E.1.1.1Medical condition in easily understood language
    Treatment of cocaine addiction
    Tratamiento de la adicción a la cocaína
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10009815
    E.1.2Term Cocaine addiction
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy and safety of TV-1380 in facilitating abstinence in cocaine-dependent subjects.
    El objetivo principal de este estudio es valorar la eficacia y la seguridad de TV-1380 para facilitar la abstinencia en sujetos dependientes de la cocaína.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess the efficacy of TV-1380 in reducing measures of cocaine use compared to placebo treatment.
    El objetivo secundario del estudio es valorar la eficacia de TV-1380 para reducir los criterios de consumo de cocaína en comparación con el tratamiento con placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.
    b. Male or female aged 18-60 years (inclusive).
    c. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for cocaine dependence as determined by the Structured Clinical Interview (SCID) in screening.
    d. Seek treatment for cocaine dependence.
    e. Provide at least four urine samples and have at least one cocaine-positive urine sample during the two-week screening period as measured by an on-site, qualitative benzoylecgonine (BE) assay.
    f. Have a home address and can give contact locator information.
    g. Are, in the opinion of the investigator, likely to complete the 12-week treatment phase of the study.
    a. Capacidad de entender y que hayan entendido y que den su consentimiento informado por escrito para cumplir el protocolo de tratamiento.
    b. Varones o mujeres de 18 a 60 años de edad (ambos inclusive).
    c. Cumplimiento de los criterios diagnósticos de dependencia de la cocaína del Manual diagnóstico y estadístico de los trastornos mentales, cuarta edición, texto revisado (DSM-IV-TR) en la Entrevista clínica estructurada (SCID) en la selección.
    d. Solicitud de tratamiento de la dependencia de la cocaína.
    e. Que den al menos cuatro muestras de orina y tengan al menos una muestra de orina positiva para cocaína durante el período de selección de dos semanas en el análisis cualitativo de benzoilecgonina (BE) (tiras reactivas) realizado en el centro.
    f. Que tengan un domicilio y puedan dar información de una persona de contacto.
    g. En opinión del investigador, que tengan probabilidad de completar la fase de tratamiento de 12 semanas del estudio.
    E.4Principal exclusion criteria
    a. Meet DSM-IV-TR criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, benzodiazepines, or marijuana OR have physiological dependence on alcohol requiring detoxification.
    b. Have all the available urine tests positive for opiates during the 2 weeks screening period (episodic urine tests positive for opiates are allowed).
    c. Are currently treated with an opiate-substitute (buprenorphine or methadone) maintenance treatment or received therapy with any opiate-substitute within 90 days preceding screening.
    d. Have one or more severe psychiatric disorders as determined by the Mini International Neuropsychiatric Interview (MINI) such as psychosis, schizophrenia, bipolar disease, major depression, or eating disorders in screening.
    e. Have one or more major neurologic disorders such as dementia or organic brain disease.
    f. Have other serious medical illnesses or other potentially life threatening or progressive medical illness that may compromise subject safety or study conduct as determined by the site MD.
    g. Had previous suicidal attempt or current suicidal risk as determined by the site MD
    h. Have liver function tests (ALT, AST) greater than x3 times upper limit of normal (ULN) or any other clinically significant abnormal laboratory value during the screening period as determined by the site MD.
    i. Have known allergy or hypersensitivity to natural or recombinant butyrylcholinesterase (BChE), human serum albumin (HSA) or any other component of the formulation.
    j. Current court mandated cocaine use treatment.
    k. Have been treated for cocaine addiction within the 30 days preceding screening.
    l. Are unable to complete the study protocol because of probable incarceration or relocation from the clinical area.
    m. Have taken any investigational drugs within 60 days preceding screening.
    n. Have participated in an experimental trial assessing a cocaine vaccine anytime before study screening.
    o. Are currently exposed to or have been exposed to pesticides or any other organophosphates (e.g., agricultural workers) within 60 days preceding screening.
    p. Women of child-bearing potential who do not practice an acceptable method of birth control.
    q. Pregnant or nursing women.
    a. Cumplimiento de los criterios del DSM-IV-TR de dependencia actual de cualquier sustancia psicoactiva diferente de cocaína, alcohol, nicotina, benzodiacepinas o marihuana O dependencia fisiológica del alcohol que exija desintoxicación.
    b. Resultados positivos para opiáceos en todas las pruebas de orina durante el período de selección de 2 semanas (se permiten pruebas de orina episódica positivas para opiáceos).
    c. Tratamiento de mantenimiento actual con un sustitutivo de los opiáceos (buprenorfina o metadona) o tratamiento con sustitutivos de los opiáceos en los 90 días previos a la selección.
    d. Uno o más trastornos psiquiátricos graves determinados por la Minientrevista neuropsiquiátrica internacional (MINI) como psicosis, esquizofrenia, enfermedad bipolar, depresión mayor o trastornos de la conducta alimentaria en la selección.
    e. Uno o más trastornos neurológicos importantes, como demencia o enfermedad cerebral orgánica.
    f. Otras enfermedades médicas graves u otra enfermedad médica peligrosa para la vida o progresiva que pueda comprometer la seguridad de los sujetos o la realización del estudio determinada por el médico del centro.
    g. Intento de suicidio previo o riesgo de suicidio actual determinado por el médico del centro.
    h. Pruebas de función hepática (ALT, AST) más de x3 veces el límite superior normal (LSN) o cualquier valor analítico anormal de importancia clínica durante el período de selección determinado por el médico del centro.
    i. Alergia o hipersensibilidad conocida a la butirilcolinesterasa (BChE) natural o recombinante, la albúmina sérica humana (HSA) o cualquier otro componente de la formulación.
    j. Tratamiento en curso del consumo de cocaína por mandato de un tribunal.
    k. Tratamiento de la adicción a la cocaína en los 30 días previos a la selección.
    l. Imposibilidad de completar el protocolo del estudio por probable encarcelamiento o mudanza fuera de la zona clínica.
    m. Toma de cualquier fármaco en investigación en los 60 días anteriores a la selección.
    n. Participación en un ensayo experimental en el que se valore una vacuna contra la cocaína en cualquier momento antes de la selección para el estudio.
    o. Exposición actual o previa a plaguicidas u otros organofosforados (p. ej., agricultores) en los 60 días previos a la selección.
    p. Mujeres en edad fértil que no utilicen un método anticonceptivo aceptable.
    q. Mujeres embarazadas o en período de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study is defined as abstinence from cocaine during the last three weeks of the treatment phase (weeks 10-12), based on daily self-report of no use confirmed by urine samples considered negative for cocaine metabolites.
    El criterio de valoración de la eficacia principal de este estudio es la abstinencia de cocaína durante las tres últimas semanas de la fase de tratamiento (semanas 10-12), basado en la autoevaluación diaria de ausencia de consumo confirmada mediante muestras de orina que se consideren negativas para los metabolitos de la cocaína.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint for this study is defined as abstinence from cocaine during the last 3 weeks of the treatment phase (weeks 10-12), based on daily self-report of no-use confirmed by urine samples considered negative for cocaine metabolites.
    El criterio de valoración de la eficacia principal de este estudio es la abstinencia de cocaína durante las tres últimas semanas de la fase de tratamiento (semanas 10-12), basada en la autoevaluación diaria de ausencia de consumo confirmada mediante muestras de orina que se consideren negativas para los metabolitos de la cocaína.
    E.5.2Secondary end point(s)
    The secondary objective of the study is to assess the efficacy of TV-1380 in reducing measures of cocaine use compared to placebo treatment.
    El objetivo secundario del estudio es valorar la eficacia de TV-1380 para reducir los criterios de consumo de cocaína en comparación con el tratamiento con placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary efficacy endpoint for this study is defined as percent of urine samples that are considered negative for cocaine metabolites out of all planned urine samples during the last 8 weeks of the treatment phase (weeks 5-12, 24 samples).
    Missing or not analyzable urine samples will be considered as not negative for cocaine metabolites.
    El criterio de valoración secundario de la eficacia de este estudio es el porcentaje de muestras de orina que se consideran negativas para los metabolitos de la cocaína de todas las muestras de orina programadas durante las 8 últimas semanas de la fase de tratamiento (semanas 5-12, 24 muestras).
    Las muestras de orina no disponibles o no analizables se considerarán no negativas para los metabolitos de la cocaína.
    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 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 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.8.2.4Number of treatment arms in the trial3
    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 EEA7
    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
    Spain
    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
    Follow-up visit 4 weeks after the last study drug dose (EoS visit, week 20).
    In subjects with a positive immunogenicity result at the EOS visit (planned Visit 43, or 4 weeks after the last study drug dose in case of early termination), additional testing for antibodies will be done targeting 6+/-2 months after last study drug dose.
    Visita de seguimiento 4 semanas después de la última dosis del fármaco del estudio (visita de FE, semana 20).
    En los sujetos con resultado de inmunogenicidad positiva en la visita del FE (visita 43 prevista, o 4 semanas después de la última dosis del fármaco del estudio en caso de terminación prematura), se harán análisis adicionales de anticuerpos centrados en los 6+/-2 meses después de la última dosis del fármaco del estudio.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 210
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 210
    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 Decision2013-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
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