E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment-resistant schizophrenia |
Esquizofrenia resistente al tratamiento |
|
E.1.1.1 | Medical condition in easily understood language |
Treatment-resistant schizophrenia |
Esquizofrenia resistente al tratamiento |
|
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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10072913 |
E.1.2 | Term | Treatment-resistant schizophrenia |
E.1.2 | System Organ Class | 100000004873 |
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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 tolerability of the long-term treatment with Lu AF35700 |
Evaluar la seguridad y la tolerabilidad del tratamiento a largo plazo con Lu AF35700 |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Not applicable |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For 16159A-patients • The patient has completed Study 16159A. • The patient is able to read and understand the Informed Consent Form. • The patient has signed the Informed Consent Form specific for Study 16159B. • The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator’s clinical judgement.
For 16323A-patients • The patient has completed the dosing period of Study 16323A. • The patient is able to read and understand the Informed Consent Form. • The patient has signed the Informed Consent Form specific Study 16159B. • The patient has a confirmed diagnosis of schizophrenia according to DSM-5™. • The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator’s clinical judgement.
For Other Patients • The patient has schizophrenia, diagnosed according to DSM-5™. • The patient is a man or woman, aged ≥18 years. • The patient has been prescribed oral antipsychotic treatment at the recommended dose range as stated in the summary of product characteristics or equivalent label for 6 weeks prior to the Screening Visit. • The patient has a PANSS total score ≥60 and ≤90 at Screening and Baseline Visits. • The patient has a Clinical Global Impression – Severity of Illness (CGI-S) score ≤4. • The patient is in need of a change in the current antipsychotic treatment and, according to the investigator’s clinical judgement, the patient can potentially benefit from a switch to another treatment including, but not limited to, any of the following reasons: - lack of adequate response to his or her current antipsychotic medication; - poor tolerability to his or her current antipsychotic medication; - unwillingness of the patient to adhere to his or her current antipsychotic medication. |
Pacientes 16159A que: • El paciente ha completado el estudio 16159A; • El paciente es capaz de leer y comprender el Formulario de Consentimiento Informado; • El paciente ha firmado el Formulario de Consentimiento Informado específico del estudio 16159B; • El paciente puede potencialmente beneficiarse con el tratamiento de 52 semanas con Lu AF35700 de acuerdo con el criterio clínico del investigador.
Pacientes 16323A que: • El paciente ha completado el periodo de administración del estudio 16323A; • El paciente es capaz de leer y comprender el Formulario de Consentimiento Informado; • El paciente ha firmado el Formulario de Consentimiento Informado específico del estudio 16159B; • El paciente tiene un diagnóstico confirmado de esquizofrenia de acuerdo con el DSM-5™. • El paciente puede potencialmente beneficiarse con el tratamiento de 52 semanas con Lu AF35700 de acuerdo con el criterio clínico del investigador.
Para Otros pacientes: • El paciente tiene esquizofrenia, diagnosticada de acuerdo con el DSM-5™. • El paciente es capaz de leer y comprender el Formulario de Consentimiento Informado; • El paciente ha firmado el Formulario de Consentimiento Informado específico del estudio 16159B; • El paciente es hombre o mujer, de 18 años de edad o más; • Al paciente se le ha recetado un tratamiento con antipsicóticos orales dentro del rango de dosis recomendadas establecido en el SmPC o en un documento/etiqueta equivalente durante 6 semanas antes de la Visita de Selección; • El paciente tiene una puntuación total en la escala PANSS ≥60 y 90 en las Visitas de Selección e Inicial; • El paciente tiene una puntuación en la Impresión Clínica Global – Gravedad de la Enfermedad (ICG-GE) 4. • El paciente necesita un cambio en su tratamiento antipsicótico actual y, de acuerdo con el juicio clínico del investigador, el paciente potencialmente puede beneficiarse del cambio a otro tratamiento por razones que incluyen, pero no se limitan, a las siguientes: - falta de respuesta adecuada a su medicamento antipsicótico actual; - poca tolerabilidad a su medicamento antipsicótico actual; - poca disposición del paciente para adherirse a su tratamiento antipsicótico actual. |
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E.4 | Principal exclusion criteria |
For 16159A-patients • The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16159A. • The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers “Yes” to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers “Yes” to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
For 16323A-patients • The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16323A. • The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers “Yes” to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers “Yes” to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
For Other Patients • The patient has any current psychiatric disorder (DSM-5™ criteria) other than schizophrenia established as the primary diagnosis. • The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit. • The patient is treated with clozapine at the time of the Screening Visit. • The patient has a substance use disorder (except nicotine) which according to the investigator’s judgment may compromise the patient’s ability to comply with the study procedures, or preclude the benefits of the study medication. • The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers “Yes” to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers “Yes” to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS |
Para pacientes 16159A: • El paciente se ha diagnosticado con un trastorno psiquiátrico primario distinto a la esquizofrenia durante el estudio 16159A. • El paciente, en opinión del investigador, presenta un riesgo significativo de suicidio, o: - Responde «Sí» a cualquier pregunta en la sección de Comportamiento Suicida del C-SSRS, o: - Responde «Sí» a las preguntas 4 y 5 de la sección Ideas Suicidas del C-SSRS. Para pacientes 16323A: • Al paciente se le ha diagnosticado un trastorno psiquiátrico primario diferente a la esquizofrenia durante el estudio 16323A. • El paciente, en opinión del investigador, presenta un riesgo significativo de suicidio, o: - Responde «Sí» a cualquier pregunta en la sección de Comportamiento Suicida del C-SSRS, o: - Responde «Sí» a las preguntas 4 y 5 en la sección Ideas Suicidas del C-SSRS.
Para Otros pacientes: • El paciente tiene cualquier trastorno psiquiátrico actual (criterios del DSM-5™) distinto a la esquizofrenia como su diagnóstico principal. • El paciente está experimentando una exacerbación aguda de sus síntomas psicóticos en la Visita de Selección, entre la Visita de Selección y la Visita Inicial o en la Visita Inicial; • El paciente recibe tratamiento con clozapina en el momento de la Visita de Selección; • El paciente sufre de un trastorno deconsumo de sustancias que, a juicio del investigador, podría afectar la capacidad del paciente para cumplir con los procedimientos del estudio o, evitar los beneficios del medicamento del estudio. • El paciente, en opinión del investigador, presenta un riesgo significativo de suicidio, o: - Responde «Sí» a cualquier pregunta de la sección Comportamiento Suicida del C-SSRS, o: - Responde «Sí» a las preguntas 4 y 5 de la sección Ideas Suicidas del C-SSRS. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability Based on the Safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, waist circumference and ECG |
Seguridad y tolerabilidad Basado en variables de seguridad (acontecimientos adversos, pruebas de laboratorio, constantes vitales, masa corporal, perímetro de cintura y ECG |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From dosing to end of study (57 weeks) |
Desde la administración al final del estudio (57 semanas) |
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E.5.2 | Secondary end point(s) |
Not applicable |
not applicable |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Not applicable |
|
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 49 |
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 |
Argentina |
Bulgaria |
Canada |
Czech Republic |
Estonia |
Finland |
Italy |
Mexico |
Poland |
Romania |
Russian Federation |
Serbia |
Slovakia |
Spain |
United States |
|
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
|
The last protocol-specified contact with the last patient ongoing in the study |
ultimo contacto según especificaciones del protocolo del ultimo participante activo en el estudio |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |