Clinical Trials Register

Summary
EudraCT Number:	2017-003471-54
Sponsor's Protocol Code Number:	TAK-831-2002
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:	2018-01-05
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-003471-54

A.3

Full title of the trial

A Phase 2, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Dose levels of TAK-831 in Adjunctive Treatment of Adult Subjects With Negative Symptoms of Schizophrenia

Estudio de fase II, aleatorizado, con doble enmascaramiento, controlado con placebo y con grupos paralelos de 12 semanas de duración, para evaluar la eficacia, seguridad, tolerabilidad y farmacocinética de 3 dosis de TAK-831 en el tratamiento adyuvante de sujetos adultos con síntomas negativos de esquizofrenia

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to evaluate the efficacy, safety and tolerability of TAK-831 in patients
with schizophrenia

Estudio para evaluar la eficacia, seguridad y tolerabilidad de TAK-831 en pacientes con esquizofrenia.

A.4.1

Sponsor's protocol code number

TAK-831-2002

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1201-2722

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Millennium Pharmaceuticals Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Millennium Pharmaceuticals, Inc
B.5.2	Functional name of contact point	Medical Director
B.5.3	Address:
B.5.3.1	Street Address	40 Landsdowne St.,
B.5.3.2	Town/ city	Cambridge, MA
B.5.3.3	Post code	02139
B.5.3.4	Country	United States
B.5.4	Telephone number	900 811 335
B.5.5	Fax number	0018576004140
B.5.6	E-mail	nicholas.demartinis@takeda.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	TAK-831
D.3.2	Product code	TAK-831
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TAK-831
D.3.9.2	Current sponsor code	TAK-831
D.3.9.3	Other descriptive name	TAK-831
D.3.9.4	EV Substance Code	SUB177202
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	TAK-831
D.3.2	Product code	TAK-831
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TAK-831
D.3.9.2	Current sponsor code	TAk-831
D.3.9.3	Other descriptive name	TAK-831
D.3.9.4	EV Substance Code	SUB177202
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	TAK-831
D.3.2	Product code	TAK-831
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TAK-831
D.3.9.2	Current sponsor code	TAK-831
D.3.9.3	Other descriptive name	TAK-831
D.3.9.4	EV Substance Code	SUB177202
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Schizophrenia

Esquizofrenia

E.1.1.1

Medical condition in easily understood language

Schizophrenia

Esquizofrenia

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10039626
E.1.2	Term	Schizophrenia
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine whether add-on TAK-831 is superior to placebo
on the Positive and Negative Syndrome Scale Negative Symptom Factor Score (PANSS NSFS).

Determinar si el tratamiento complementario con TAK-831 es superior al placebo en cuanto a la puntuación factorial para síntomas negativos de la escala de síndromes positivo y negativo (PANSS NSFS).

E.2.2

Secondary objectives of the trial

To determine whether add-on TAK-831 is superior to placebo on the Brief Negative Symptom Scale (BNSS) total score, on the Brief Assessment of Cognition in Schizophrenia (BACS) composite cognition score, on global severity as measured by the Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S) score, on global improvement as measured by the Clinical Global Impression-Schizophrenia-Improvement (CGI-SCH-I) score, on the Schizophrenia Cognition Rating Scale (SCoRS) assessment of cognitive functional outcome.To determine whether add-on TAK-831 is superior to placebo on the Positive and Negative Syndrome Scale (PANSS) total score and additional subscales and factors. To determine whether add-on TAK-831 is superior to placebo on subject-reported quality of life as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire-18 item version (Q-LES-Q-18) total score and subscales.
To assess the safety and tolerability of TAK-831. To assess the PK of TAK-831.

Determinar si el tratamiento complementario con TAK-831 es superior al placebo en cuanto a la puntuación total de la BNSS,en cuanto a la puntuación compuesta de la evaluación breve de cognición en esquizofrenia (BACS),en la gravedad global medida con la puntuación de la escala de impresión clínica global de la esquizofrenia - escala de gravedad (CGI-SCH-S), en la evaluación de la actividad cognitiva mediante la escala de valoración de la cognición en la esquizofrenia (SCoRS), en cuanto a la puntuación total de la PANSS y otras subescalas y factores.
Determinar si el tratamiento complementario con TAK-831 es superior al placebo en la calidad de vida comunicada por el paciente y medida con la puntuación total del cuestionario sobre calidad de vida, disfrute y satisfacción de 18 elementos (Q-LES-Q-18) y sus subescalas.
Evaluar la seguridad y tolerabilidad de TAK-831.
Evaluar la FC de TAK-831.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• The subject has a current diagnosis of schizophrenia as defined by the MINI 7.0.2 for Psychotic Disorders for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The subject’s initial diagnosis must be ≥1 year from Screening.
• The subject is male or female and aged 18 to 50 years, inclusive.
• The subject is receiving primary background antipsychotic therapy at a total daily dose between 2 and 6 mg of risperidone equivalents or its equivalent (as outlined in an Antipsychotic Dose Equivalency reference supplied to the sites). Concomitant treatment with a subtherapeutic dose of a second antipsychotic may be permitted with sponsor or designee approval if used as a hypnotic (maximum of quetiapine 100 mg or its equivalent once daily at bedtime [QHS]), but not if it is used for refractory positive psychosis symptoms. Under this exception, the total daily dose the second antipsychotic will not have to be included in the calculation of the 6 mg/day risperidone-equivalent limit.
• The subject is treated with a stable regimen of psychotropic medications with no clinically meaningful change (no increase in dose, <20% decrease in dose for tolerability) the 2 months prior to the Screening Visit.
• The subject has a BNSS total score (12-item, excluding number 4) ≥28; stable Single-Blind Placebo Run-in and Baseline scores (≤20% change from the Screening score).
• The subject has no more than moderate-severe (≤5) rating on PANSS positive symptom items P1, P3, P4, P5, P6, or unusual thought content (G9), with a maximum of 2 of these items rated '5'; no more than moderate (≤4) rating on conceptual disorganization (P2). In addition, the subject must demonstrate stable Single-Blind Placebo and Baseline scores (≤20% change from the Screening score) in the total of these PANSS items.
• There is evidence that the subject has stable symptomatology ≥3 months prior to the Screening Visit (eg, no hospitalizations for schizophrenia, no emergency room admission due to symptoms of schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia).
• The subject must have an adult informant (eg, family member, social worker, caseworker, residential facility staff, or nurse who spends ≥4 hours/week with the subject) considered reliable by the investigator who will be able to provide input for completing study rating scales, including the PANSS and SCoRS.

•El sujeto está diagnosticado de esquizofrenia tal y como se define en la MINI 7.0.2 para los trastornos psicóticos para el Manual diagnóstico y estadístico de los trastornos mentales quinta edición (DSM-5). El diagnóstico inicial del paciente debe datar de ≥ 1 año antes de la selección.
•El sujeto, hombre o mujer, tiene entre 18 y 50 años de edad, inclusive.
•El sujeto recibe una dosis total diaria de entre 2 y 6 mg de equivalentes de la risperidona o sus equivalentes como principal medicación antipsicótica de fondo (según una tabla de equivalencia de dosis de antipsicóticos proporcionada a los centros). Puede permitirse el tratamiento concurrente con una dosis subterapéutica de un segundo antipsicótico con la aprobación del promotor, o quien este designe, si se utiliza como hipnótico (máximo 100 mg de quetiapina o sus equivalentes una vez al día, por la noche antes de acostarse), pero no si se emplea para tratar síntomas positivos refractarios de psicosis. Para esta excepción, la dosis total diaria del segundo antipsicótico no se incluirá en la determinación del límite de 6 mg/día de risperidona o equivalente.
•El sujeto se trata con una pauta estable de psicotrópico sin ningún cambio clínicamente significativo (ningún aumento de la dosis, disminución < 20 % de la dosis para tolerabilidad) durante los 2 meses previos a la visita de selección.
•El sujeto presenta una puntuación total ≥28 en la BNSS (12 puntos, excluido el número 4) y puntaciones estables iniciales y en el rodaje con placebo y enmascaramiento doble (cambio ≤20 % desde la puntuación inicial).
•El sujeto no presenta una valoración superior a moderada-grave (≤ 5) en los elementos de síntomas positivos de la escala PANSS P1, P3, P4, P5, P6 o contenido insólito del pensamiento (G9), con un máximo de 2 de estos elementos calificados como "5"; ausencia de valoración superior a moderada (≤ 4) en desorganización conceptual (P2). Además, el sujeto debe demostrar puntuaciones iniciales y en el rodaje con placebo y enmascaramiento único estables (cambio ≤20 % desde la puntuación inicial) en el total de estos elementos de PANSS.
•Existen pruebas de que el sujeto presenta una sintomatología estable ≥3 meses antes de la visita de selección (p. ej., ningún ingreso hospitalario por esquizofrenia, ningún ingreso en urgencias debido a síntomas de esquizofrenia, ningún aumento en el nivel de atención psiquiátrica debido a la agravación de los síntomas de esquizofrenia, etc.).
•El sujeto debe contar con un informante adulto (p. ej., un miembro de la familia, trabajador social, asistente social, empleado de institución residencial o enfermero que pase ≥4 horas/semana con el paciente) y fiable, a juicio del investigador, que pueda aportar datos para rellenar las escalas de valoración del estudio, como PANSS y SCoRS.

E.4

Principal exclusion criteria

• The subject has a lifetime diagnosis of schizoaffective disorder; a lifetime diagnosis of bipolar disorder; or a lifetime diagnosis of obsessive compulsive disorder based on the MINI combined with the general psychiatric evaluation. As an exception, subjects with a historical prior lifetime diagnosis of schizoaffective disorder may be enrolled in the study with sponsor or designee approval provided that the principal investigator can attest that the subject’s overall history and current clinical presentation and history is most consistent with schizophrenia, not schizoaffective disorder.
• The subject has a recent (within the last 6 months) diagnosis of panic disorder, depressive episode, or other comorbid psychiatric conditions requiring clinical attention based on the MINI for DSM-5 and the general psychiatric evaluation.
• The subject has a diagnosis of substance use disorder (with the exception of nicotine dependence) within the preceding 6 months based on the MINI for DSM-5 and the general psychiatric evaluation.
• The subject is participating in a formal structured nonpharmacological therapeutic treatment program (cognitive remediation, cognitive-behavioral therapy, intensive symptom/vocational rehabilitation) for <3 months prior to randomization. In addition, initiation of such nonpharmacological treatment programs is not permitted during study participation through the Day 84 Visit.
• The subject exhibits more than a minimal level of antipsychotic-induced parkinsonism symptoms, as documented by a score on the modified Simpson Angus Scale (SAS) (excluding item number 10, Akathisia) >6.
• The subject has evidence of depression as measured by a Calgary Depression Scale Score (CDSS) >9.
• The subject's diagnosis of schizophrenia occurred prior to 12 years of age.
• The subject has a history of developmental intellectual disability or mental retardation.
• Antipsychotic plasma levels for the subject’s primary background antipsychotic are below the minimum acceptable concentration criteria per the Antipsychotic Drug Level Reference Document at the Screening or Placebo Run-in Visits. This criterion is not applicable to subjects on a primary background antipsychotic for which a clinical assay is unavailable (ie, not listed in the Antipsychotic Drug Level Reference Document).
• The subject has received clozapine for the treatment of schizophrenia within a 5-year period before Screening.
• The subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the subject has attempted suicide within the past year prior to Screening. Subjects who have positive answers on item number 4 or 5 on the C-SSRS (based on the past year) prior to randomization are excluded.
• The subject has a history of brain trauma associated with loss of consciousness for >15 minutes.
• The subject has received electroconvulsive therapy within 6 months (180 days) before Screening.
• The subject does not have a stable residence or is homeless.

•El sujeto presenta un diagnóstico de trastorno esquizoafectivo, trastorno bipolar o trastorno obsesivo-compulsivo crónicos según la entrevista MINI y el examen psiquiátrico general. Como excepción, los sujetos con un diagnóstico previo de trastorno esquizoafectivo pueden participar en el estudio tras obtener la autorización del promotor o quien este designe siempre que el investigador principal confirme que los antecedentes globales del sujeto y la presentación clínica actual así como los antecedentes son más coherentes con esquizofrenia que con trastorno esquizoafectivo.
•El paciente presenta un diagnóstico reciente (en los últimos 6 meses) de trastorno de angustia, episodio depresivo u otras afecciones psiquiátricas concurrentes que requieran atención clínica según la MINI para el DSM-5 y el examen psiquiátrico general.
•El sujeto presenta un diagnóstico de trastorno por uso de sustancias ilícitas (con la excepción de la dependencia nicotínica) en los 6 meses anteriores según la MINI para el DSM-5 y el examen psiquiátrico general.
•El sujeto está participando en algún programa estructurado de tratamiento no farmacológico (rehabilitación cognitiva, terapia cognitivo-conductual o rehabilitación sintomática o vocacional intensiva) durante <3 meses antes de la aleatorización. Además, el inicio de estos programas de tratamiento no farmacológico no está permitido durante la participación en el estudio hasta el día de la Visita 84.
•El sujeto muestra más que un nivel mínimo de síntomas de parkinsonismo inducidos por antipsicóticos tal y como indica una puntuación de la escala de Angus Simpson modificada (SAS) (excluido el elemento número 10, acatisia) >6.
•El sujeto presenta signos de depresión determinados por la escala de depresión de Calgary (CDSS) >9.
•El diagnóstico de esquizofrenia del sujeto se emitió antes de los 12 años de edad.
•El sujeto presenta antecedentes de discapacidad intelectual y del desarrollo o retraso mental.
•Concentraciones plasmáticas del antipsicótico de fondo principal de los pacientes por debajo de los criterios para la concentración mínima aceptable según el documento de referencia de fármacos antipsicóticos en las visitas de selección o del periodo de rodaje con placebo. Este criterio no resulta aplicable a los pacientes tratados con un antipsicótico de fondo principal para el que no se disponga de ensayo clínico (es decir, no incluido en el documento de referencia de nivel de fármacos antipsicóticos).
•El sujeto ha recibido clozapina para el tratamiento de la esquizofrenia durante 5 años anteriormente a la selección.
•El sujeto recibe un tratamiento concurrente susceptible de afectar a la cognición según determine el investigador principal junto con el promotor o quien este designe.

E.5 End points

E.5.1

Primary end point(s)

Change from Baseline on the PANSS NSFS.

Cambios desde basal en PANSS NSFS

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 84

Día 84

E.5.2

Secondary end point(s)

Change from Baseline on the PANSS NSFS at Days 28 and 56.
Change from Baseline on the BNSS at Day 84.
Change from Baseline on the BACS composite score at Day 84.
Change from Baseline on the CGI-SCH-S score at Day 84.
CGI-SCH-I score at Day 84.
Change from Baseline on the SCoRS at Day 84.
Change from Baseline on the PANSS total score and additional subscales and factors at Day 84.
Change from Baseline on the Q-LES-Q-18 total score and subscales at Day 84.
TAK-831 plasma concentrations.

•Cambio respecto al valor de referencia en PANSS NSFS en los Días 28 y 56.
•Cambio respecto al valor de referencia en BNSS en el Día 84.
•Cambio respecto al valor de referencia en la puntuación compuesta de BACS en el Día 84.
•Cambio respecto al valor de referencia en la puntuación de CGI-SCH-S en el Día 84.
•La puntuación de CGI-SCH-I en el Día 84.
•Cambio respecto al valor de referencia en SCoRS en el Día 84.
•Cambio respecto al valor de referencia en la puntuación total de PANSS y otras subescalas y factores en el Día 84.
•Cambio respecto al valor de referencia en la puntuación total de Q-LES-Q-18 en el Día 84.
•Concentraciones plasmáticas de TAK-831.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 28, 56 and 84.

Dias 28, 56 y 84.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Italy

Spain

United States

E.8.7

Trial has a data monitoring committee

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

Last patient last safety follow up visit

Última visita de seguimiento de seguridad del último paciente.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

315

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Mental illness

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

158

F.4.2.2

In the whole clinical trial

315

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-05-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-03-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-01-12

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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