E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Schizophrenia |
Esquizofrenia |
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E.1.1.1 | Medical condition in easily understood language |
Schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hearing or seeing things that are not there, suspiciousness and delusions (false beliefs). |
Esquizofrenia, enfermedad mental con una serie de síntomas, incluidos pensamiento y discurso desorganizado, ilusiones auditivas y visuales, suspicacia y delirios (creencias falsas). |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039636 |
E.1.2 | Term | Schizophrenia simple |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months. |
El objetivo de este estudio es estimar el porcentaje de sujetos que cumplen los criterios de remisión sintomática tras una transición de 12 meses de tratamiento con dosis flexibles de PP3M en sujetos con esquizofrenia previamente estabilizados con PP1M durante al menos 4 meses. |
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E.2.2 | Secondary objectives of the trial |
To determine :
. Percentage of Participants Achieving Symptomatic remission Based on Positive and Negative Syndrome scale (PANSS) at Month 6, 9 and 12.
. Time to Symptomatic Remission.
. Percentage of Participants who Meet the Remission Severity Criteria.
. Non-Inferiority of Change in PANSS Total Score From Baseline to Month 12 last-observation-carried-forward (LOCF) Endpoint.
. Percentage of Participants With PANSS Total Score of greater than or equal to (>=)20 Percent. |
Para determinar:
. Proporción de sujetos que cumplen los criterios de remisión sintomática basada en la escala de síndromes positivo y negativo (PANSS) en los meses 6, 9 y 12.
. El tiempo hasta la remisión sintomática.
. La proporción de sujetos que cumplen los criterios de intensidad de la remisión.
. Cambio no inferior de la puntuación total de la escala PANSS desde el momento basal a la última observación arrastrada (UOA) al mes 12.
. Proporción de sujetos con respuesta de la escala PANSS, definida como la mejoría ?20 % de la puntuación total de la escala PANSS. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
. Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a diagnosis of schizophrenia . Able to read, understand, and sign the informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study . Willing and able to fill out self-administered questionnaires . Willing and able to adhere to the prohibitions and restrictions specified in the protocol . A woman of childbearing potential must have a negative urine pregnancy test at Screening and baseline . A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug |
. Cumplir los criterios del Manual diagnóstico y estadístico de los trastornos mentales, quinta edición (DSM-5)para un diagnóstico de esquizofrenia. . Ser capaz de leer, entender y firmar el formulario de consentimiento informado indicando que entiene el objetivo y los procedimientos del estudio y que desea participar en el estudio. . Estar dispuesto y ser capaz de responder a los cuestionarios de autoevaluación. . Estar dispuesto y ser capaz de respetar las prohibiciones y las restricciones especificadas en este protocolo. . Las mujeres en edad fértil deberán dar negativo en una prueba de embarazo en orina en la visita de selección y en el momento basal. . Las mujeres deberán comprometerse a no donar óvulos con fines de reproducción asistida durante el estudio y durante 6 meses después de recibir la última dosis del fármaco del estudio |
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E.4 | Principal exclusion criteria |
. His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example, clinically notable hypothyroidism, organic brain disorder) . Experienced intolerable side effects during treatment with paliperidone palmitate 1-month formulation (PP1M) . Has a known hypersensitivity to paliperidone or risperidone . Has received any other long-acting injectable antipsychotic medication other than PP1M within the last 4 months before the first injection of the study drug paliperidone palmitate 3-month formulation (PP3M) . Has received clozapine during the last 3 months before the Screening visit. . Is considered to be at imminent risk of suicide, even after clinical intervention . Has a serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities . Has a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome . Is a woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of PP3M - Has participated in an investigational drug trial in the 30 days prior to the Screening visit |
. Su diagnóstico psiquiátrico se debe a los efectos farmacológicos directos de una sustancia (p. ej., una droga de abuso o un medicamento) o a un proceso médico general (p. ej., hipotiroidismo clínicamente notable, trastorno cerebral orgánico). . Ha sufrido efectos secundarios intolerables durante el tratamiento con PP1M. . Tiene hipersensibilidad conocida a la paliperidona o la risperidona. . Ha recibido cualquier otra medicación antipsicótica inyectable de acción prolongada distinta de PP1M en los últimos 4 meses previos a la primera inyección del fármaco del estudio (PP3M). . Ha recibido clozapina durante los últimos 3 meses previos a la visita de selección. . Se considera que existe un riesgo inminente de suicidio, incluso después de la intervención clínica. . Padece un proceso médico grave e inestable, incluidas anomalías analíticas de importancia clínica recientes y actuales. . Tiene antecedentes o síntomas actuales de disquinesia tardía o síndrome neuroléptico maligno. . Es una mujer que está embarazada o en periodo de lactancia, o que planea quedarse embarazada mientras participe en este estudio o en los 6 meses siguientes a la última dosis de PP3M. . Ha participado en un ensayo con un fármaco en investigación en los 30 días previos a la visita de selección. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS) |
Porcentaje de sujetos que cumplen los criterios de remisión sintomática según la escala de síndromes negativo y positivo (PANSS). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At last-observation-carried-forward (LOCF) Endpoint. |
En el punto final última observación arrastrada. |
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E.5.2 | Secondary end point(s) |
(1) Percentage of Participants Achieving Symptomatic Remission Based on Positive and Negative Syndrome Scale (PANSS) at Month 6, 9 and 12 (2) Time to Symptomatic Remission (3) Percentage of Participants who Meet the Remission Severity Criteria (4) Non-Inferiority of Change in PANSS Total Score From Baseline to Month 12 last-observation-carried-forward (LOCF) Endpoint (5) Percentage of Participants With PANSS Total Score of greater than or equal to (>=)20 Percent |
(1) Proporción de sujetos que cumplen los criterios de remisión sintomática basada en la escala de síndromes positivo y negativo (PANSS) en los meses 6, 9 y 12.
(2) El tiempo hasta la remisión sintomática.
(3) La proporción de sujetos que cumplen los criterios de intensidad de la remisión.
(4) Cambio no inferior de la puntuación total de la escala PANSS desde el momento basal a la última observación arrastrada (UOA) al mes 12.
(5) Proporción de sujetos con respuesta de la escala PANSS, definida como la mejoría mayor o igual al 20 % de la puntuación total de la escala PANSS. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
(1) Month 6, month 9 , and month 12 (2) - (5) Up to Month 12 |
(1) Mes 6, mes 9 y mes 12. (2) - (5) Hasta el mes 12. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
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 | No |
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 |
Croatia |
Denmark |
France |
Germany |
Greece |
Israel |
Italy |
Korea, Democratic People's Republic of |
Netherlands |
Russian Federation |
Saudi Arabia |
Spain |
Sweden |
Taiwan |
Turkey |
United Kingdom |
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E.8.7 | Trial 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
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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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |