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    Summary
    EudraCT Number:2014-000424-23
    Sponsor's Protocol Code Number:331-13-211
    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:2014-08-14
    Trial 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 number2014-000424-23
    A.3Full title of the trial
    A 2-month, Observational, Rollover Trial to Evaluate the Safety of Subjects with Agitation Associated with Dementia of the Alzheimer?s Type who were Previously Treated with Brexpiprazole (OPC-34712) or Placebo in a Phase 3, Double-blind Trial
    Estudio clínico observacional de continuación de 2 meses de duración para evaluar la seguridad de pacientes con agitación asociada a demencia del tipo Alzheimer que recibieron tratamiento previamente con brexpiprazol (OPC-34712) o placebo en un estudio clínico doble ciego de fase III
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Observational Trial to Evaluate the Safety of Subjects with Agitation Associated with Dementia of the Alzheimer?s Type who were Previously Treated with Brexpiprazole or Placebo
    Ensayo observacional para evaluar la seguridad de pacientes con agitación asociada a demencia del tipo Alzheimer que recibieron tratamiento previamente con brexpiprazol o placebo
    A.4.1Sponsor's protocol code number331-13-211
    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 SponsorOtsuka Pharmaceutical Development & Commercialization, 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 supportOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.5.2Functional name of contact pointCatherine Aurang
    B.5.3 Address:
    B.5.3.1Street Address1 University Square Drive, Suite 500
    B.5.3.2Town/ cityPrinceton, NJ
    B.5.3.3Post code08540
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34917088660
    B.5.5Fax number+12403996202
    B.5.6E-mailCatherine.Aurang@otsuka-us.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 nameBrexpiprazole
    D.3.2Product code OPC-34712
    D.3.4Pharmaceutical form 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 INNBrexpiprazole
    D.3.9.1CAS number 913611-97-9
    D.3.9.2Current sponsor codeOPC-34712
    D.3.9.3Other descriptive nameBREXPIPRAZOLE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    Agitation Associated with Dementia of the Alzheimer's Type
    Agitación asociada con demencia del tipo Alzheimer
    E.1.1.1Medical condition in easily understood language
    Dementia of the Alzheimer's Type
    Demencia del tipo Alzheimer
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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 of subjects with agitation associated
    with dementia of the Alzheimer?s type who were previously
    treated with brexpiprazole (0.5, 1, or 2 mg/day) or placebo
    during Trial 331-12-283 or Trial 331-12-284
    Evaluar la seguridad de pacientes con agitación asociada con demencia del tipo Alzheimer que recibieron tratamiento previamente con brexpiprazol (0,5; 1 o 2 mg/día) o placebo durante el estudio clínico 331-12-283 o el estudio clínico 331 12 284
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -The investigator must assess the capacity of the subject to provide informed consent prior to enrollment and throughout the course of the trial. Once this determination is made by the investigator, the options for obtaining informed consent from and/or on behalf of the subject must be followed accordingly:
    - If the subject is deemed capable by the investigator, written informed consent will be obtained from the subject prior to the initiation of any trial protocol-required procedures. In such cases, acknowledgement from the subject?s legally acceptable representative (an individual, or judicial or other body, authorized under applicable law to consent to the subject?s participation in the clinical trial on behalf of that prospective subject) will also be obtained in accordance with state and/or local regulations prior to initiation of any trial protocol-required procedures.
    - If the subject was initially deemed capable of providing informed consent but is no longer deemed so, informed consent must be obtained from the subject?s legally acceptable representative, and assent from the subject, if possible, will be confirmed in accordance with state and/or local regulations prior to the initiation of any trial protocol-required procedures.
    - If the subject is deemed incapable by the investigator of providing consent (eg, subjects with severe dementia), written informed consent will be obtained from the subject?s legally acceptable representative prior to initiation of any trial protocol-required procedures. In such cases, assent from the subject, if possible, will be confirmed in accordance with state and/or local regulations prior to the initiation of any trial protocol-required procedures.
    - If the subject cannot provide assent, and does not dissent, then the consent of the legally acceptable representative is sufficient unless otherwise required by the governing ethics body and/or applicable state and/or local regulations.
    - If the subject dissents, then the subject is not eligible for participation in the trial.
    - If the subject initially provided assent at trial entry, but subsequently dissents to participate in the trial, then the subject will be early terminated from the trial.
    - Male and female subjects who completed both the 12-week double-blind treatment period and the 30-day safety follow-up visit of Trials 283/284.
    - Subjects with an identified caregiver who is usually assigned to care for the subject on a regular basis, has sufficient contact to describe the subjects? symptoms, and has direct observation of the subjects? behavior. The identified caregiver will be a member of the residential facility staff or other individual (eg, family member, family friend, hired professional caregiver) who meets the caregiver requirements.
    - Subjects able to satisfactorily comply with the protocol
    requirements.
    - El investigador debe evaluar la capacidad del paciente para proporcionar el consentimiento informado antes de la inscripción y a lo largo del estudio clínico. Una vez que el investigador realice esta determinación, las opciones para obtener el consentimiento informado del paciente o en nombre del paciente deben establecerse en consecuencia:
    - Si el investigador considera que el paciente está capacitado, se obtendrá el consentimiento informado por escrito del paciente antes de iniciar cualquiera de los procedimientos exigidos por el protocolo del estudio clínico. En dichos casos, también se obtendrá la aceptación del representante legalmente aceptable del paciente (una persona u órgano judicial o de otro tipo, autorizado en virtud de la ley aplicable a prestar el consentimiento para la participación del paciente en el estudio clínico en nombre de ese posible paciente) de acuerdo con las normativas nacionales, regionales y/o locales antes de iniciar cualquiera de los procedimientos exigidos por el protocolo del estudio clínico.
    - Si se consideró al paciente capacitado inicialmente para proporcionar el consentimiento informado pero ya no, debe obtenerse el consentimiento informado del representante legalmente aceptable del paciente, y se confirmará la aceptación del paciente, si es posible, de acuerdo con las normativas nacionales, regionales y/o locales antes de iniciar cualquiera de los procedimientos exigidos por el protocolo del estudio clínico.
    - Si el investigador considera que el paciente no está capacitado para proporcionar el consentimiento (p. ej., pacientes con demencia grave), se obtendrá el consentimiento informado por escrito del representante legalmente aceptable del paciente antes del inicio de cualquiera de los procedimientos exigidos por el protocolo del estudio clínico. En tales casos, se confirmará la aceptación del paciente, si es posible, de acuerdo con las normativas nacionales, regionales y/o locales antes del inicio de cualquiera de los procedimientos exigidos por el protocolo del estudio clínico.
    - Si el paciente no puede proporcionar la aceptación y no disiente, el consentimiento del representante legalmente aceptable será suficiente salvo que un organismo ético supervisor o las normativas nacionales, regionales y/o locales exijan lo contrario.
    - Si el paciente disiente, no reunirá los requisitos para participar en el estudio clínico.
    - Si el paciente acepta inicialmente en el momento de incorporarse al estudio, pero posteriormente retira su consentimiento para participar en el estudio clínico, tendrá que procederse a la finalización anticipada del estudio clínico del paciente.
    - Pacientes de sexo masculino y femenino que completaron el período de tratamiento doble ciego de 12 semanas y la visita de seguimiento de seguridad a los 30 días de los estudios clínicos 283/284.
    - Pacientes con un cuidador identificado que está normalmente asignado al cuidado habitual del paciente, tiene suficiente contacto como para describir los síntomas del paciente y puede observar directamente la conducta del paciente. El cuidador identificado será un miembro del personal del centro residencial u otra persona (p. ej., familiar, amigo, cuidador profesional contratado) que cumpla los requisitos del cuidador.
    - Pacientes que puedan cumplir satisfactoriamente con los requisitos del protocolo.
    E.4Principal exclusion criteria
    Key exclusion criteria include the following:
    - Subjects who, in the opinion of the investigator, medical monitor, or sponsor should not participate in the trial.
    Los criterios de exclusión clave incluyen los siguientes:
    - Pacientes que, en opinión del investigador, monitor médico o promotor, no deban participar en el estudio clínico.
    E.5 End points
    E.5.1Primary end point(s)
    The following safety endpoints will be evaluated during this trial.
    - Frequency and severity of AEs, serious AEs, and discontinuations from the trial due to AEs.
    - Frequency and severity of AEs related to the worsening of agitation associated with Alzheimer?s disease.
    - Frequency and severity of AEs related to the worsening of cognition associated with Alzheimer?s disease.
    - Frequency and severity of other AEs of interest (eg, falls, sedation, weight changes, or deaths).
    - Newly initiated concomitant medications for the treatment of agitation associated with Alzheimer?s disease.
    - Newly initiated concomitant medications for the treatment of cognitive symptoms associated with Alzheimer?s disease.
    - Mean change in the MMSE score from baseline (Week 12 MMSE from Trials 283/284) to Month 2/ET.
    Durante todo este estudio clínico se evaluarán los siguientes criterios de valoración de seguridad.
    - Frecuencia e intensidad de los AA, AA graves e interrupciones del estudio clínico debido a AA.
    - Frecuencia e intensidad de los AA relacionados con el empeoramiento de la agitación asociada con la enfermedad de Alzheimer.
    - Frecuencia e intensidad de los AA relacionados con el empeoramiento de la cognición asociada con la enfermedad de Alzheimer.
    - Frecuencia e intensidad de otros AA de interés (p. ej., caídas, sedación, cambios de peso o fallecimientos).
    - Medicamentos concomitantes recién iniciados para el tratamiento de la agitación asociada con la enfermedad de Alzheimer.
    - Medicamentos concomitantes recién iniciados para el tratamiento de los síntomas cognitivos asociados con la enfermedad de Alzheimer.
    - Cambio medio en la puntuación de la MMSE respecto al inicio (MMSE de la semana 12 de los estudios clínicos 283/284) hasta el mes 2/FA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    No Aplica
    E.5.2Secondary end point(s)
    Not applicable
    No Aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No Aplica
    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 No
    E.6.6Pharmacokinetic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Ensayo observacional de continuación
    Observational rollover trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA55
    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
    Croatia
    Finland
    France
    Germany
    Russian Federation
    Serbia
    Slovenia
    Spain
    Ukraine
    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
    The End of Trial Date is defined as the date for the Month 2/ET visit, or the last Date of Contact or the Date of Final Contact Attempt if the Month 2/ET visit does not occur as a clinic visit.
    La fecha de finalización del estudio clínico se define como la fecha de la visita del mes 2/FA, o la última fecha de contacto o la fecha del intento de contacto final si la visita del mes 2/FA no se produce como una visita clínica.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 494
    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 trial population will consist of male and female subjects who completed both the 12-week double-blind treatment period and the 30-day safety follow-up visit of Trials 283/284.
    La población del estudio clínico constará de pacientes de sexo masculino y femenino que completaron el período de tratamiento doble ciego de 12 semanas y la visita de seguimiento de seguridad a los 30 días de los estudios clínicos 283/284.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 520
    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 Decision2014-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-30
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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