E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute pre/agitated patients with personality disorder |
Agitación en pacientes con trastorno de personalidad. |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with personality disorder that arrive to the ER with an acute pre/agitation state |
Pacientes con trastorno de personalidad que acuden a urgencias en un estado de agitación o pre-agitación agudo. |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
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 main objective of the clinical trial is to assess the effectiveness, defined as time respone of loxapine 9.1mg in acute pre/agitated patients with personality disorder. This respones is define as 1 (very much improvement) or 2 (much improvement) score in the Clinical Global Impression – Improvement scale (CGI-I) |
El objetivo principal del ensayo es evaluar la eficacia, definida como el tiempo hasta la respuesta a la loxapina 9.1mg en pacientes con pre/agitación aguda asociada a trastorno de personalidad. La respuesta se define como una puntuación de 1(“Enorme mejoría”) o 2 (“Gran mejoría”) en la escala de Impresión Clínica Global de Mejoría (CGI-I). |
|
E.2.2 | Secondary objectives of the trial |
To assess the effectiveness defined as PANSS-EC total score ≤14 and sub-item scale <4
To assess the effectiveness, defined as 4 (normal), 5 (mild calmness) or 6 (moderate calmness) score in the Agitation-Calmness (ACES)
To assess the effectiveness, defined as % pacients who respond to treatment 10, 20 and 60 minutes after loxapine 9.1mg inhalation
To assess the number of patients who need rescue treatment.
To assess the safety and tolerability of the IMP
To assess the use of mechanic restrain in the subjects of the study |
Evaluar la eficacia, definida como una puntuación total de la PANSS-EC ≤14 y que los sub-ítem de la escala sean <4.
Evaluar la eficacia, definida como una puntuación de 4 (Normal), 5(Levemente calmado), o 6(moderadamente calmado) en la escala de Agitation-Calmness (ACES)
Evaluar la eficacia, definida como el porcentaje de pacientes que responde al tratamiento 10’, 20’ y 60’ después de la loxapina inhalada 9.1mg.
Evaluar la proporción de pacientes que necesitan una dosis adicional del medicamento del ensayo.
Evaluar la proporción de paciente que necesitan medicación de rescate.
Evaluar la seguridad y tolerabilidad del medicamento del ensayo.
Evaluar la utilización de la contención mecánica en los pacientes del ensayo. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient able to read and understand the patient's information sheet Patient who had signed voluntarily the informed consent form Men or women between ≥ 18 and ≤ 65 years old Pacient with a personality disorder diagnosis (as DSM-5) Pacient considered to be clinically pre-agitated or agitated with a CGI-S score above or equal to 4. |
Paciente capaz de leer y entender la hoja de Información al Paciente.
Paciente que haya firmado el formulario de Consentimiento Informado.
Hombre o mujer con edad ≥ 18 años y ≤ 65 años.
Paciente diagnosticado de trastorno de personalidad (según criterios DSM-5).
Paciente que se considere que está clínicamente pre-agitado o agitado con un valor superior o igual a 4 en la escala CGI-S. |
|
E.4 | Principal exclusion criteria |
Any specific contraindication stated in the Summary of product characteristics. Patients with any allergy or intolerance to loxapine or amoxapine Patients with agitation caused basically by an acute intoxication (according to the investigator) Patients who are thought to have a relevant suicide risk (according to the investigator) Patients with alcohol or psycho-active drugs withdrawal symptoms or intoxication, incompatible with their clinical trial participation (according to the investigator) Patients with acute respiratory symptoms or active airway illness (such as asthma or COPD). Women with childbearing potential with a positive urine test result or women who are breastfeeding Patients with any severe acute illness or instable medical condition (other than personality disorder) that might prevent their participation in the study (according to the investigator) Any team staff or their family members, or any subordinate (or relatives) of the team staff Patients who had been given the IMP 30 days prior to the selection visit Patients who (according to the investigator) cannot follow the study procedures. |
- Cualquier contraindicación especificada en la Ficha Técnica (Apéndice 3)
- Paciente con alergia o intolerancia a la loxapina o a la amoxapina.
- Pacientes con agitación causada principalmente por una intoxicación aguda (a juicio del investigador).
- Pacientes que el investigador considere que tienen un riesgo importante de suicidio.
- Pacientes con síntomas de abstinencia o intoxicación aguda por alcohol o fármacos psicoactivos, incompatibles con su participación en el ensayo a juicio del investigador.
- Pacientes con síntomas respiratorios agudos o enfermedad activa de las vías respiratorias (como asma o enfermedad pulmonar obstructiva crónica).
- Mujeres en edad fértil que tengan un resultado positivo en una prueba de embarazo en orina en la visita inicial o estén amamantando.
- Paciente con alguna enfermedad aguda grave o patología médica inestable (que no sea el trastorno de personalidad) que pudiera comprometer la participación del paciente en el estudio a juicio del investigador.
- El paciente es un miembro del personal involucrado en el estudio o de sus familiares más cercanos, o es un subordinado (o un familiar directo de un subordinado) del personal involucrado en el estudio.
- Pacientes que hayan recibido un producto en investigación en los 30 días anteriores a la selección.
- Paciente que, en opinión del investigador, no pueda cumplir con los procedimientos del protocolo del estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Clinical Global Impression-Severity (CGI-S) Clinical Global Impression-Improvement (CGI-I) |
Escala de Impresión Clínica Global - Severidad Escala de Impresión Clínica Global - Mejoría |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
0 ,10, 20 and 60 minutes |
0, 10, 20 y 60 minutos |
|
E.5.2 | Secondary end point(s) |
Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC) Agitation-Calmness Evaluation Scale (ACES) |
Escala de Síndrome Positivo y Negativo-Componente de Excitación (PANSS-EC) Escala de evaluación de la Agitación - Sedación (ACES) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
0 ,10, 20 and 60 minutes |
0, 10, 20 y 60 minutos |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
naturalistic, prospective, unicentric pilot study |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |