E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cognitive Impairment Associated With Schizophrenia |
Deterioro cognitivo asociado a la esquizofrenia |
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E.1.1.1 | Medical condition in easily understood language |
Cognitive Impairment and Schizophrenia |
Deterioro Cognitivo y Esquizofrenia |
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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 |
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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 |
To evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in subjects with schizophrenia. |
Evaluar la seguridad y la eficacia de Luvadaxistat en comparación con un placebo en la mejora del rendimiento cognitivo en participantes con esquizofrenia. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of luvadaxistat compared with placebo on improving cognitive function in subjects with schizophrenia. |
Evaluar la eficacia de Luvadaxistat en comparación con un placebo en la mejora del rendimiento cognitivo en participantes con esquizofrenia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Completed written informed consent 2. Subject must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures. 3. Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 4. The initial diagnosis of schizophrenia must be ≥1 year before screening. 5. The subject is currently receiving a stable regimen of psychotropic medications 6. Subject has stable symptomatology ≥3 months before the screening visit. 7. The subject must have an adult informant. 8. A body weight of at least 45 kg and a body mass index (BMI) of 18.0 to 45.0 kg/m2, inclusive. |
1. Haber cumplimentado el consentimiento informado por escrito. 2. El participante debe tener entre 18 y 50 años de edad (incluído) para cumplir con todos los procedimientos del protocolo. 3. Diagnóstico de esquizofrenia según la definición del Manual diagnóstico y estadístico de los trastornos mentalesm(DSM-5). 4. El diagnóstico inicial de esquizofrenia debe haberse hecho, como mínimo, 1 año antes de la selección. 5. El participante está recibiendo actualmente un tratamiento estable de medicamentos psicotrópicos. 6. El participante presenta una sintomatología estable ≥3 meses antes de la visita de selección. 7. El participante debe tener un informante adulto. 8. Un peso corporal de al menos 45 kg y un índice de masa corporal (IMC) de entre 18,0 y 45,0 kg/m2. |
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E.4 | Principal exclusion criteria |
1. Pregnant or breastfeeding or plans to become pregnant during the study. 2. Exhibit more than a minimal level of extrapyramidal signs/symptoms. 3. Schizophrenia diagnosis occurred before 12 years of age. 4. Lifetime diagnosis of schizoaffective disorder, bipolar disorder, or obsessive-compulsive disorder. 5. Recent occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions. 6. 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 6 months before screening. 7. Diagnosis of moderate or severe substance use disorder (with the exception of nicotine dependence) within 12 months prior to screening. 8. Positive drug screen for disallowed substances 9. Any other medical or psychiatric condition or cognitive impairment that may interfere with study conduct or clinical assessments. |
1. Estar embarazada, en periodo de lactancia o tener previsto quedarse embarazada durante el estudio. 2. Mostrar más de un nivel mínimo de signos/síntomas extrapiramidales. 3. El diagnóstico de esquizofrenia se produjo antes de los 12 años de edad. 4. Diagnóstico de trastorno esquizoafectivo, diagnóstico de trastorno bipolar o diagnóstico de trastorno obsesivo-compulsivo de por vida. 5. Trastorno de pánico, episodio depresivo u otras afecciones psiquiátricas concomitantes recientes. 6. El investigador considera que tiene un riesgo inminente de suicidio o de autolesiones, de lesionar a otras personas o dañar bienes, o que ha presentado un comportamiento suicida en los 6 meses anteriores a la selección. 7. Diagnóstico de trastorno moderado o grave por uso de sustancias (con la excepción de la dependencia a la nicotina) en los 12 meses anteriores a la selección. 8. Detección de drogas positiva para sustancias no permitidas. 9. Cualquier otra afección médica o psiquiátrica o deterioro cognitivo que pueda interferir con la realización del estudio o las evaluaciones clínicas. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) composite score. |
Variación con respecto al valor inicial en la puntuación compuesta de la evaluación breve de la cognición en la esquizofrenia (BACS). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline to Day 98. |
Valor inicial hasta el día 98. |
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E.5.2 | Secondary end point(s) |
- Change from baseline on the Schizophrenia Cognition Rating Scale (SCoRS) interviewer score. - Change from baseline on the Continuous Performance Test-Identical Pairs (CPT-IP) test. - Change from baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) test. - Change from baseline on the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT). - Change from baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT). - Change from baseline on the Clinical Global Impression-Severity Scale (CGI-S) score. |
- Variación con respecto al valor inicial en la puntuación del entrevistador de la escala de evaluación cognitiva en esquizofrenia (SCoRS). - Variación con respecto al valor inicial en la prueba de rendimiento continuo, versión pares idénticos (CPT-IP). - Variación con respecto al valor inicial en la prueba breve de memoria visuoespacial revisada (BVMT-R). - Variación con respecto al valor inicial en la prueba de inteligencia emocional de Mayer-Salovey-Caruso (MSCEIT). - Variación con respecto al valor inicial en la herramienta de evaluación para la medición de la capacidad funcional con realidad virtual (VRFCAT). - Variación con respecto al valor inicial en la puntuación de la escala de impresión clínica global de la gravedad (CGI-S). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline to Day 98. |
Valor inicial hasta el día 98. |
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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 | No |
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Estudio aleatorizado, doble ciego, comparativo con placebo, seguido de un tratamiento abierto |
A Randomized, Double-Blind, Placebo-Controlled, Followed by Open-Label Treatment |
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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 | 3 |
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 | 22 |
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 |
Mexico |
United States |
Bulgaria |
Spain |
Czechia |
Serbia |
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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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Last Patient Last Visit |
Último paciente Última visita |
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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 | 3 |
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 | 3 |