E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Negative symptoms of schizophrenia |
Síntomas negativos de la esquizofrenia |
|
E.1.1.1 | Medical condition in easily understood language |
Negative symptoms of schizophrenia |
Síntomas negativos de la esquizofrenia |
|
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 | 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 | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia. |
Evaluar la eficacia, la seguridad y la tolerabilidad de AVP-786, comparado con placebo, para el tratamiento de .los síntomas negativos de la esquizofrenia |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effects of AVP-786, as compared with placebo, on global assessments of severity and improvement of negative symptoms of schizophrenia. |
Evaluar los efectos de AVP-786, en comparación con placebo, en las evaluaciones globales de la gravedad y la mejora de los síntomas negativos de la esquizofrenia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients 18 to 60 years of age, inclusive, at time of informed consent. 2. Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria for schizophrenia confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Version 7.0.2 3. Participants must have well-controlled positive symptoms and prominent negative symptoms as defined by Positive and Negative Syndrome Scale (PANSS) criteria. 4. Participants should be treated with second-generation atypical antipsychotic drug (SGA) including long-acting injectable (LAI) treatments, are eligible if they are stable and adherent to their dosing schedule. 5. Participants must have a reliable informant (e.g., case manager, social worker, family member). The informant should be able to spend an adequate amount of time with the participant to be able to address behaviors, activities, and symptoms.
Please refer to the protocol for complete list of inclusion criteria. |
1. Pacientes de 18 a 60 años de edad, inclusive, al momento del consentimiento informado 2. Pacientes que cumplan con los criterios de diagnóstico de la esquizofrenia del Manual de diagnóstico y estadística de trastornos mentales, 5.a edición (DSM-V) confirmados a través de la Minientrevista neuropsiquiátrica internacional (M.I.N.I.) Versión 7.0.2 3. Los pacientes deben tener los síntomas positivos bien controlados y síntomas negativos destacables según los criterios de la Escala de síndrome positivo y negativo (PANSS). 4. Los pacientes deben estar recibiendo tratamiento con un fármaco antipsicótico atípico de segunda generación (SGA), incluidos los tratamientos inyectables de acción prolongada (LAI), son elegibles si están estables y se adhieren a su calendario de dosis. 5. Los pacientes deben tener un informante confiable (p. ej., coordinador asistencial, trabajador social, familiar). El informante debe pasar una cantidad suficiente de tiempo con el paciente para poder abordar comportamientos, actividades y síntomas.
Refiéranse al protocolo para una lista completa de criterios de inclusión. |
|
E.4 | Principal exclusion criteria |
1. Participants with current major depressive disorder (MDD) 2. Patients with a diagnosis of schizoaffective disorder or bipolar disorder. 3. Participants currently using anticholinergic medications 4. Participants recently hospitalized as in-patients
Please refer to protocol for complete list of exclusion criteria. |
1. Pacientes con trastorno depresivo mayor (MDD). 2. Pacientes con diagnóstico de trastorno esquizoafectivo o trastorno bipolar. 3. Pacientes que están usando medicamentos anticolinérgicos actualmente. 4. Pacientes hospitalizados actualmente como pacientes ingresados.
Refiéranse al protocolo para una lista completa de criterios de inclusión. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the change from Baseline to Week 15 in the PANSS Marder negative factors score. |
El criterio de valoración principal de eficacia es el cambio desde el inicio hasta la semana 15 en el puntaje de los factores negativos de Marder de la PANSS. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Baseline to Week 15 |
Desde el inicio hasta la semana 15 |
|
E.5.2 | Secondary end point(s) |
Secondary efficacy endpoints include change from Baseline to Week 15 for the following outcomes measures: - NSA-16 Global Negative Symptom Score - PGI-S - PGI-C |
Los criterios de valoración secundarios incluyen el cambio desde el inicio hasta la semana 15 en los siguientes: • Puntaje global de síntomas negativos de la NSA-16 • PGI-S • PGI-C |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From Baseline to Week 15 |
Desde el inicio hasta la semana 15 |
|
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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tolerabilidad |
|
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) | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 2 |
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 |
United States |
Poland |
Bulgaria |
Spain |
Hungary |
Ukraine |
Serbia |
|
E.8.7 | Trial 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
|
LVLS |
Última visita de último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |