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    Summary
    EudraCT Number:2019-002813-20
    Sponsor's Protocol Code Number:331-201-00242
    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:2019-12-20
    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 number2019-002813-20
    A.3Full title of the trial
    A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder
    Ensayo multicéntrico, aleatorizado, de dosis flexible y doble ciego de brexpiprazol frente a placebo para el tratamiento de adultos con trastorno límite de la personalidad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
    Ensayo de brexpiprazol para el tratamiento con trastorno límite de la personalidad
    A.3.2Name or abbreviated title of the trial where available
    A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
    Ensayo de brexpiprazol para el tratamiento con trastorno límite de la personalidad
    A.4.1Sponsor's protocol code number331-201-00242
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04100096
    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 pointHeather Sutton
    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 number+14436210289
    B.5.6E-mailheather.sutton-cw@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.3.9.4EV 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    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 compare the efficacy of brexpiprazole versus placebo for the treatment of subjects with a diagnosis of BPD.
    Comparar la eficacia de brexpiprazol frente a placebo para el tratamiento de pacientes con diagnóstico de TLP
    E.2.2Secondary objectives 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 la tolerabilidad de brexpiprazol para el tratamiento de pacientes con diagnósticos de TLP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subjects, ages 18 to 65, inclusive, at the time of informed consent
    - Subjects with a primary DSM-5 diagnosis of BPD confirmed by the SCID-5-PD at screening.
    - At screening and Day 0, subjects must have a total score ≥ 12 on the ZAN-BPD scale.
    - Subjects who, in the investigator's judgment, require treatment with a medication for BPD.
    - Subjects willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
    - Pacientes de ambos sexos, con edades entre 18 y 65 años inclusive, en el momento de la firma del consentimiento
    - Los pacientes tendrán un diagnóstico DSM-5 de TLP confirmado por el SCID-5-PD en la selección.
    - En la en la selección y el día 0, los pacientes tendrán y una puntuación total ≥ 12 en la escala ZAN-BPD.
    - Pacientes que, a criterio del investigador, requieren tratamiento con un medicamento para el trastorno límite de la personalidad.
    - Pacientes dispuestos a suspender todos los medicamentos prohibidos para cumplir los períodos de reposo farmacológico exigidos por el protocolo antes y durante el período del ensayo.
    E.4Principal exclusion criteria
    - Sexually active males or females of childbearing potential 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. Male or female subjects identifying as homosexual with exclusively homosexual 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 through 30 days after the last dose of IMP.
    - Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
    - Subjects with a concurrent DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Also, subjects with a concurrent diagnosis of bipolar I disorder, bipolar II disorder, delirium, dementia, amnesia, eating disorder, antisocial personality disorder, or other cognitive disorders. Subjects with MDD, PTSD, ADHD, panic disorder, or generalized anxiety can be included if symptoms have been stable, these disorders are not the primary focus of treatment and changes in any treatment for these disorders would not likely be required for the duration of the trial.
    - Subjects currently in psychotherapy specifically used to target BPD symptoms at time of screening.
    - Subjects who have had electroconvulsive treatment or transcranial magnetic stimulation.
    - Subjects with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit.
    - Subjects who fulfill the following criteria related to suicide and/or suicidal ideation are excluded:
    - Subjects who have a significant risk of committing violent acts, serious self-harm, or suicide based on history or routine psychiatric status examination, or those who are homicidal or considered to be a high risk to others, or subjects with a response of "yes" on the C-SSRS Suicidal Ideation Item 5, OR
    - Subjects with a response of "yes" on the C-SSRS Suicidal Behavior Items, OR
    - Subjects who have had 3 suicide attempts, OR,
    - Subjects who have had 3 or more hospitalizations due to suicidal behavior. Note that subjects who have engaged in non-suicidal self-injurious behavior within the 90 days prior to screening or at Day 0 are eligible, unless the behavior is better described as an actual attempt, interrupted attempt, or aborted attempt according to C-SSRS definition and/or investigator judgment and therefore exclusionary.
    Subjects with a response of "yes" on the C-SSRS Suicidal Ideation Item 4 within the 90 days prior to screening or at Day 0 may be included following discussion with a medical monitor.
    - Subjects with hypothyroidism or hyperthyroidism or an abnormal result for free T4 at screening.
    - Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.
    - Subjects with uncontrolled hypertension, symptomatic hypotension, or orthostatic hypotension.
    - Subjects with epilepsy or a history of seizures, except for a single seizure episode.
    - Subjects who received brexpiprazole in any prior clinical trial or subjects who have taken or are taking commercially available brexpiprazole (Rexulti®).
    - Subjects with a history of neuroleptic malignant syndrome, serotonin syndrome, or clinically significant tardive dyskinesia.
    - Subjects with a history of true allergic response to more than 1 class of medication.
    - Subjects who are currently either inpatient or partially hospitalized.
    - Subjects who participated in a clinical trial within 90 days prior to screening or who participated in more than 2 clinical trials within a year prior to screening.
    - Hombres o mujeres sexualmente activos y con capacidad para procrear que no aceptan utilizar dos métodos anticonceptivos diferentes o practicar la abstinencia sexual durante el ensayo y 30 días después de la última dosis del PEI. Es posible que no se requiera utilizar métodos anticonceptivos a los pacientes hombres o mujeres que se identifiquen como homosexuales y que tengan exclusivamente parejas del mismo sexo, después de hablar sobre ello con el investigador y el monitor médico. Los pacientes hombres también deben aceptar no donar esperma desde la selección para el ensayo hasta 30 días después de la última dosis del PEI.
    - Mujeres en período de lactancia o con una prueba de embarazo positiva antes de recibir el PEI.
    - Pacientes con diagnóstico simultáneo de esquizofrenia o trastorno esquizoafectivo según el DSM-5. Además, los pacientes con diagnóstico simultáneo de trastorno bipolar I, trastorno bipolar II, delirio, demencia, amnesia, trastorno alimentario, trastorno de personalidad asocial u otros trastornos cognitivos. Además, se puede incluir a pacientes con trastorno depresivo mayor, trastorno por estrés postraumático, trastorno por déficit de atención con hiperactividad, trastorno de pánico o ansiedad generalizada si los síntomas se han mantenido estables, si estos trastornos no son el enfoque principal del tratamiento y si es probable que no se requieran cambios durante el ensayo en ninguno de los tratamientos para estos trastornos.
    - Pacientes que reciben en el momento de la selección psicoterapia específicamente para los síntomas de trastorno límite de la personalidad.
    - Pacientes que han recibido tratamiento electroconvulsivo o estimulación magnética transcraneal.
    - Pacientes con un diagnóstico de trastorno por abuso de sustancias o alcohol en los 90 días anteriores a la visita de selección.
    - Los pacientes que cumplan los siguientes criterios relacionados con el suicidio y/o ideas de suicidio están excluidos:
    - los pacientes que tengan un riesgo significativo de cometer actos violentos, riesgo de hacerse daños graves a sí mismos o de suicidio en función de los antecedentes o el examen de estado psiquiátrico, o los que se consideren homicidas o que representan un alto riesgo para los demás, o pacientes que respondieron “sí” al ítem 5 de ideas suicidas en la C-SSRS; O
    - los pacientes que respondieron “sí” a los puntos de comportamiento suicida en la C-SSRS; O
    - los pacientes que hayan tenido 3 intentos de suicidio; O
    - los pacientes que hayan estado hospitalizados 3 veces o más debido a su comportamiento suicida. Tenga en cuenta que los pacientes que hayan tenido un comportamiento autolesivo sin ánimo de suicidarse en los 90 días anteriores a la selección o en el día 0 son elegibles, a menos que el comportamiento se describa mejor como un intento real, un intento interrumpido o un intento abortado conforme a la definición de la C-SSRS y/o el criterio del investigador y por lo tanto, queden excluidos.
    Los pacientes que respondieron “sí” al ítem 4 de ideas suicidas de la C-SSRS en los 90 días anteriores a la selección o en el día 0 pueden incluirse después de conversar sobre ello con el monitor médico.
    - Pacientes con hipotiroidismo o hipertiroidismo o un resultado anormal de la T4 libre en la selección.
    - Los pacientes que presenten actualmente trastornos neurológicos, hepáticos, renales, metabólicos, hematológicos, inmunitarios, cardiovasculares, pulmonares o gastrointestinales clínicamente importantes.
    - Los pacientes con hipertensión, hipotensión sintomática o hipotensión ortostática no controlada.
    - Los pacientes con epilepsia o antecedentes de convulsiones, excepto si solo han tenido un episodio de convulsiones.
    - Los pacientes que han recibido brexpiprazol en cualquier ensayo clínico anterior o que han tomado o están tomando actualmente brexpiprazol disponible comercialmente (Rexulti®).
    - Los pacientes con antecedentes de síndrome neuroléptico maligno, síndrome serotoninérgico o discinesia tardía clínicamente importante.
    - Los pacientes con antecedentes de respuesta alérgica verdadera a más de 1 clase de medicamentos
    - Los pacientes que están actualmente ingresados o parcialmente ingresados.
    - Los pacientes que hayan participado en un estudio clínico en los 90 días anteriores a la selección o que hayan participado en más de 2 ensayos clínicos en el último año.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) total score
    A clinician-administered scale with a total score range of 0 to 36. A higher score represents a higher severity of disease symptoms.
    1. Variación en la puntuación total de la escala de calificación de Zanarini para el trastorno de límite de la personalidad (ZAN-BPD) respecto al valor inicial.
    Una escala que administra el médico con un rango de puntuación total de 0 a 36. Una puntuación más alta representa una mayor gravedad de los síntomas de la enfermedad.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: Up to 12 weeks
    Duración: hasta 12 semanas
    E.5.2Secondary end point(s)
    1. Change from baseline in the Clinical Global Impression - Severity of Illness (CGI-S) score
    An observer-rated scale with a total score range of 0 to 7. A higher score represents a worse outcome.

    2. Change from baseline in the Patient's Global Impression of Severity (PGI-S) for each trial visit during the double-blind treatment period
    A 7-point single-item self-report scale for the patient to rate the severity of symptoms of BPD. A higher score denotes more severe symptoms.

    3. Patient's Global Impression of Change (PGI-C) Scale Score
    A 7-point single-item self-report scale depicting a subject's rating of overall change in their condition since starting trial medication. With a higher score denoting a worse outcome.

    4. Clinical Global Impression - Improvement (CGI-I) Scale Score
    An observer-rated scale with a total score of 0 to 7. A higher score represents a worse outcome.
    1. Variación en la puntuación de la Impresión clínica global respecto al valor inicial: escala de gravedad de la enfermedad (CGI-S).
    Una escala que administra un observador con un rango de puntuación total de 0 a 7. Una puntuación más alta representa un resultado peor.

    2. Variación en la impresión global del paciente sobre la gravedad (PGI-S) respecto al valor inicial para cada visita del ensayo durante el período de tratamiento con doble enmascaramiento.
    Una escala autoinformada de un solo ítem y de 7 puntos para que el paciente califique la gravedad de los síntomas del trastorno límite de personalidad. Una puntuación más alta indica síntomas más graves.

    3. Puntuación de la escala de impresión global del paciente sobre el cambio (PGI-C).
    Una escala autoinformada de un solo ítem y de 7 puntos para que el paciente califique la variación en general de su afección desde que comenzó con el medicamento del ensayo. Una puntuación más alta representa un resultado peor.

    4. Impresión clínica global: escala de mejoría (CGI-I).
    Una escala que administra un observador con una puntuación total de 0 a 7. Una puntuación más alta representa un resultado peor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time Frame: Up to 12 weeks
    Duración: 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 Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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: 240
    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 may be offered entry into an open-label extension trial.
    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 Decision2020-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-27
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