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    Summary
    EudraCT Number:2019-002897-30
    Sponsor's Protocol Code Number:331-201-00195
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-10
    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 number2019-002897-30
    A.3Full title of the trial
    A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Adult Subjects With Borderline Personality Disorder
    Ensayo multicéntrico en abierto para evaluar la seguridad y tolerabilidad de brexpiprazol en el tratamiento de sujetos adultos con trastorno límite de la personalidad”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
    Ensayo en abierto de brexpiprazol en el tratamiento del trastorno límite de la personalidad
    A.4.1Sponsor's protocol code number331-201-00195
    A.5.4Other Identifiers
    Name:INDNumber:141091
    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 pointOtsuka Call Center
    B.5.3 Address:
    B.5.3.1Street Address2440 Research Boulevard
    B.5.3.2Town/ cityRockville
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number844-687-8522
    B.5.6E-mailOtsukaRMReconciliation@rmpdc.org
    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.3.9.4EV Substance CodeSUB91646
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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
    Borderline Personality Disorder
    Trastorno límite de la personalidad
    E.1.1.1Medical condition in easily understood language
    Borderline Personality Disorder
    Trastorno límite de la personalidad
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10006034
    E.1.2Term Borderline personality disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10006033
    E.1.2Term Borderline personality
    E.1.2System Organ Class 10037175 - Psychiatric 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 evaluate the safety and tolerability of brexpiprazole for the treatment of subjects with a diagnosis of BPD.
    Evaluar la seguridad y tolerabilidad de brexpiprazol para el tratamiento de sujetos con diagnóstico de TLP.
    E.2.2Secondary objectives of the trial
    Exploratory Efficacy
    Eficacia exploratoria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects, who completed the last treatment visit of the previous double-blind brexpiprazole BPD trial and who, in the opinion of the investigator, could potentially benefit from administration of brexpiprazole for the treatment of BPD.
    2) Male or female outpatients, ages 18 to 65 years, inclusive, at the time of informed consent of the previous double-blind brexpiprazole BPD trial.
    3) Subjects who are able to complete the consent process and/or consent obtained from a legally acceptable representative (as required by the institutional review board [IRB]/independent ethics committee [IEC]) prior to the initiation of any protocol-required procedures.
    4) Ability, in the opinion of the principal investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited medication, and to read and understand the written word in order to be reliably rated on assessment scales.
    1) Pacientes que completaron la última visita de tratamiento del anterior ensayo doble ciego con brexpiprazol para el TLP y que, a criterio del investigador, podrían llegar a beneficiarse de la administración de brexpiprazol para el tratamiento contra el TLP.
    2) Pacientes ambulatorios, de ambos sexos, de entre 18 y 65 años de edad (inclusive) en el momento del consentimiento informado del anterior ensayo doble ciego con brexpiprazol contra el TLP.
    3) Pacientes que puedan completar el proceso de consentimiento u obtención del consentimiento de un representante legal (según lo exija el Comité de Revisión Institucional [CRI]/Comité de Ética Independiente [CEI]), antes de comenzar ningún procedimiento que requiera el protocolo.
    4) Capacidad, a criterio del investigador principal, de comprender la naturaleza del ensayo y de cumplir los requisitos del protocolo, inclusive las pautas posológicas prescritas, la toma de comprimidos y la suspensión de los medicamentos prohibidos, además de capacidad de leer y comprender textos escritos para poder disponer de una puntuación fiable en las escalas de evaluación.
    E.4Principal exclusion criteria
    1) Sexually active males or females of childbearing potential (FOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, intrauterine device, birth control pill, birth control implant, birth control depot injection, condom with spermicide, sponge with spermicide, or occlusive cap (vaginal diaphragm or cervical/vault cap) with spermicide. Male or female subjects identifying as homosexual with exclusively same-sex partners may not be required to practice birth control methods following discussion with the investigator and medical monitor.
    Male subjects must also agree not to donate sperm from trial screening/baseline through 30 days after the last dose of IMP.
    2) Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
    3) Subjects who fulfill the following criteria related to suicide and/or suicidal ideation at entry are excluded:
    - Subjects who have a significant risk of committing violent acts, serious self-harm, or suicide, or those who are homicidal or considered to be a high
    risk to others, or subjects with a response of “yes” on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item 5 (Active Suicidal
    Ideation with Specific Plan and Intent), OR
    - Subjects with a response of “yes” on the C-SSRS Suicidal Behavior Items Actual Attempt, Interrupted Attempt, or Aborted Attempt
    - Subjects who endorse engaging in preparatory acts and/or non-suicidal self-injury may be included according to investigator judgment, provided the
    behavior has not increased significantly in frequency or severity during the preceding double-blind trial period, and after discussion and approval by the medical monitor.
    4) Subjects with abnormal laboratory tests results, vital signs results, or electrocardiogram (ECG) findings, unless, based on the investigator’s judgment, the findings are not medically significant and would not impact the safety of the subject or the interpretation of the trial results. The medical monitor should be contacted to discuss individual cases, as needed. In addition, subjects with the following laboratory test and ECG results at
    screening must be excluded from the trial:
     Platelets ≤ 75000/mm3
     Hemoglobin ≤ 9 g/dL
     Neutrophils, absolute ≤ 1000/mm3
     Aspartate aminotransferase (AST) > 2 × the upper limit of normal (ULN)
     Alanine aminotransferase (ALT) > 2 × ULN
     Creatine phosphokinase (CPK) > 3 × ULN, unless discussed with and approved by the medical monitor
     Creatinine ≥ 2 mg/dL
     QT interval corrected for heart rate using Fridericia’s formula (QTcF) ≥ 450 msec in men and ≥ 470 msec in women, unless due to ventricular
    pacing. Tests with exclusionary results should be repeated to ensure reproducibility of the abnormality before excluding a subject based on the criteria noted above. For ECGs, perform 3 consecutive recordings. If 2 of the 3 remain exclusionary then the subject must be excluded.
    1) Hombres sexualmente activos o mujeres en edad fértil que no acepten la utilización de 2 métodos distintos de control anticonceptivo o la abstinencia durante el ensayo y durante los 30 días siguientes a la última dosis del PEI. Si se utiliza algún método anticonceptivo, deben usarse dos de los siguientes métodos: vasectomía, ligadura de trompas, dispositivo intrauterino, píldora anticonceptiva, implante anticonceptivo, inyecciones anticonceptivas de depósito, preservativo o esponja con espermicida o capuchón oclusivo (diafragma vaginal o capuchón cervical/cúpula vaginal) con espermicida. Es posible que, tras comentarlo con el investigador y el supervisor médico, no se exija que utilicen métodos anticonceptivos a los participantes que se identifiquen como homosexuales con parejas exclusivamente del mismo sexo.
    Los pacientes hombres deben estar de acuerdo, además, en no donar esperma desde la selección/el inicio del ensayo y durante los 30 días siguientes a la administración de la última dosis del PEI.
    2) Mujeres en período de lactancia o que hayan obtenido un resultado positivo en alguna prueba de embarazo antes de recibir el PEI.
    3) Se excluirá a los pacientes que cumplan con los siguientes criterios relacionados con el suicidio o las tendencias suicidas en el momento de su incorporación:
    - Pacientes que presenten un riesgo considerable de cometer actos violentos, autolesionarse gravemente o suicidarse, o los que presenten tendencias homicidas o se consideren un gran riesgo para otras personas, así como pacientes con una respuesta afirmativa en el ítem 5 sobre ideación suicida de la Escala de puntuación de la intensidad de las intenciones suicidas de Columbia (Columbia-Suicide Severity Rating Scale, C-SSRS; ideación suicida activa con plan específico e intención); O
    - Pacientes con una respuesta afirmativa a los ítems de conducta suicida de la C-SSRS, intento real, intento interrumpido o intento abortado;
    - Podrá incluirse a los pacientes que apoyen la participación en actos preparatorios o autolesiones no suicidas, a criterio del investigador, siempre y cuando la frecuencia o gravedad de tal conducta no hayan aumentado de modo considerable durante el período del anterior ensayo doble ciego y tras comentarlo con el supervisor médico y recibir su aprobación.
    4) Pacientes con anomalías en los resultados de los análisis de laboratorio, las constantes vitales o los resultados de los electrocardiogramas (ECG) a menos que, según el criterio del investigador, los resultados no sean clínicamente importantes y no afecten a la seguridad del paciente ni a la interpretación de los resultados del ensayo. Se deberá consultar con el supervisor médico para comentar los casos particulares, según sea necesario. Además, debe excluirse del ensayo a los pacientes con los siguientes resultados en las pruebas analíticas y los ECG en el momento de la selección:
    Plaquetas ≤ 75 000/mm3
    Hemoglobina ≤ 9 g/dl
    Neutrófilos, cantidad absoluta, ≤ 1000/mm3
    Aspartato aminotransferasa (AST) > 2 veces el límite superior de la normalidad (LSN)
    Alanina aminotransferasa (ALT) > 2 veces el LSN
    Creatinfosfocinasa (CPK) > 3 veces el LSN, salvo que se haya consultado con el supervisor médico y lo haya aprobado
    Creatinina ≥ 2 mg/dl
    Intervalo QT corregido para la frecuencia cardíaca mediante la fórmula de Fridericia (QTcF) ≥ 450 ms en hombres y ≥ 470 ms en mujeres, a menos que dispongan de estimulación ventricular. Antes de excluir a un paciente basándose en los criterios señalados antes, deben repetirse una vez las pruebas con resultados excluyentes para garantizar la reproducibilidad de la anomalía. En el caso de los ECG, deben realizarse 3 pruebas consecutivas. Si dos de las 3 continúan siendo excluyentes, deberá excluirse al paciente.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of AEs.
    Frecuencia y gravedad de los EA
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 12 weeks
    Hasta 12 semanas
    E.5.2Secondary end point(s)
     Changes in: ECGs, vital signs, clinical laboratory tests including prolactin, changes in body weight, and physical examinations;
     EPS: SAS, AIMS, and BARS;
     Suicidal ideation and behavior will be assessed using the C-SSRS.
     Change from baseline in the ZAN-BPD total score by trial visit and at the last visit (ie, Week 12/ET);
     Change from baseline in the ZAN-BPD sector scores by trial visit and at the last visit (ie, Week 12/ET);
     Change from baseline in the CGI-S score, by trial visit and at the last visit (ie, Week 12/ET);
     CGI-I score;
     Change from baseline in the PGI-S (ie, Week 12/ET);
     PGI-C score;
     Change from baseline in the HADS-A and HADS-D score (ie, Week 12/ET);
     Change from baseline in the WHODAS 2.0 score (ie, Week 12/ET);
     Change from baseline in the CGI-SS-extended scale (ie, Week 12/ET).
    Cambios en los ECG, las constantes vitales, los análisis clínicos de laboratorio (incluida la prolactina), el peso corporal y las exploraciones físicas;
    SEP: SAS, AIMS y BARS;
    Las ideas y la conducta suicidas se evaluarán mediante la escala C-SSRS.
    Variación con respecto al valor inicial en la puntuación total de ZAN-BPD, por visita del estudio y en la última visita (es decir, semana 12/FA);
    Variación con respecto al valor inicial en las puntuaciones de sectores de ZAN-BPD, por visita del estudio y en la última visita (es decir, semana 12/FA);
    Variación con respecto al valor inicial de la puntuación de la CGI-S, por visita del estudio y en la última visita (es decir, semana 12/FA);
    Puntuación en la escala CGI-I;
    Variación con respecto al valor inicial de la puntuación de la PGI-S (es decir, semana 12/FA);
    Puntuación en el cuestionario PGIC;
    Variación con respecto al valor inicial de la puntuación de HADS-A y HADS-D (es decir, semana 12/FA)
    Variación con respecto al valor inicial de la puntuación de WHODAS (es decir, semana 12/FA)
    Variación con respecto al valor inicial de la puntuación de la escala CGI-SS-extendida (es decir, semana 12/FA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 12 weeks
    Hasta 12 semanas
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Germany
    Spain
    Ukraine
    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 years1
    E.8.9.1In the Member State concerned months3
    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 months3
    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: 195
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 240
    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 all trial visits through Week 12 with no major protocol deviations will be entered into post-treatment follow-up period for up to 24 days.
    Los pacientes que completen todas las visitas del ensayo hasta la semana 12 sin desviaciones importantes del protocolo pasarán al período de seguimiento posterior al tratamiento durante un máximo de 24 días.
    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 Decision2020-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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