E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Insomnia disorder |
trastorno de insomnio |
|
E.1.1.1 | Medical condition in easily understood language |
Difficulty to sleep |
Dificultada para dormir |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
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 | 10022437 |
E.1.2 | Term | Insomnia |
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 efficacy of 25 mg and 50 mg ACT-541468 on objective sleep parameters in subjects with insomnia disorder. |
Evaluar la eficacia de ACT-541468 en dosis de 25 mg y 50 mg según parámetros de sueño objetivos en sujetos con un trastorno de insomnio. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of 25 mg and 50 mg ACT-541468 on subjective sleep parameters and next-day functioning in subjects with insomnia disorder; - To assess the safety and tolerability of ACT-541468 in subjects with insomnia disorder during treatment and upon treatment discontinuation. |
- Evaluar la eficacia de ACT-541468 en dosis de 25 mg y 50 mg según parámetros de sueño subjetivos y atendiendo al funcionamiento al día siguiente en sujetos con un trastorno de insomnio. - Evaluar la seguridad y la tolerabilidad de ACT-541468 en sujetos con insomnio durante el tratamiento y al interrumpir el tratamiento. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A sub-study [PAtient Preferences StUdy in InSomnia (PAUSe)] to collect data on the subject’s preferences will be performed, aiming to enroll at least 360 subjects both from the USA and Germany who are part of the approximately 900 subjects enrolled in the ID-078A301 study. This sub-study has the following objectives: 1) To describe the stated preferences of insomnia disorder subjects within a clinical trial by applying the DCE technique; 2) To describe the impact of treatment on the preferences of insomnia subjects; 3) To describe the relationship between demographic, disease characteristics, previous medical history and elicited preferences among insomnia subjects. In addition, the results of the sub-study may contribute to the construction of a patient-oriented benefit-risk assessment model. |
Se llevará a cabo un subestudio para recopilar datos sobre preferencias del paciente. El objetivo de la metodología de los experimentos de elección discreta es recopilar preferencias de resultados de tratamientos concretos en un subgrupo de al menos 360 sujetos en EE. UU. y Alemania que forman parte de los aproximadamente 900 sujetos inscritos en el estudio ID-078A301 empleando el cuestionario del PAUSe (PAtient Preference StUdy in InSomnia) desarrollado por Idorsia.
Este subestudio tiene los siguientes objectivos: a) describir las preferencias de los sujetos con trastorno de insomnio dentro de un ensayo clínico mediante la aplicación de técnica DCE; 2) describir el impacto del tratamiento en las preferencia de los sujetos con insomnio; d) describir la relación entre datos demográficos, características de la enfermedad, historial médico previo y preferencias entre los sujetos con insomnio. Además, los resultados del subestudio contribuirán a generar un modelo de evaluación riesgo-beneficio orientada al paciente |
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E.3 | Principal inclusion criteria |
- Signed informed consent prior to any study-mandated procedure; - Male or female aged > o = 18 years; - Insomnia disorder according to DSM-5 criteria; - Insomnia Severity Index score > or = 15; - Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography; - Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake. |
- El consentimiento informado se ha firmado antes de llevar a cabo cualquier procedimiento del estudio. - Hombre o mujer > o = 18 años de edad. - Trastorno de insomnio de acuerdo con los criterios DSM-5 - Puntuación ISI (Insomnia Severity Index) > o = 15 - Cantidad de sueño insuficiente tal y como quede anotada subjetivamente en el diario de sueño y validada objetivamente mediante polisomnografía - En el caso de las mujeres en edad fértil, se requiere resultado negativo de la prueba de embarazo en orina y usar un método anticonceptivo tal como lo exige el protocolo hasta al menos 30 días tras la última toma del tratamiento del estudio |
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E.4 | Principal exclusion criteria |
- Body mass index below 18.5 or above 40.0 kg/m2; - Any lifetime history of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/hypopnea; - Cognitive behavioral therapy (CBT) for any indication is allowed, only, if CBT started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study; - Self-reported usual daytime napping > o = 1 hour per day and > o = 3 days per week; - Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview; - Mini Mental State Examination (MMSE) score < 25 in subjects > o = 50 years; - For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study; - History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments. - Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol. |
- Índice de masa corporal inferior a 18,5 o superior a 40,0 kg/m2. - Antecedentes de trastornos respiratorios relacionados con el sueño, como la enfermedad obstructiva pulmonar crónica y la apnea del sueño. - La terapia cognitivo-conductual (TCC) para cualquier indicación se permite solo si la TCC se inició al menos 1 mes antes de la visita 3 y el sujeto acepta seguir con la terapia durante el estudio. - Siestas diurnas notificadas por el sujeto de > o = 1 h al día y > o = 3 días a la semana. - Trastornos mentales agudos o que provoquen inestabilidad diagnosticados por medio de la Mini International Neuropsychiatric Interview (Mini Entrevista Neuropsiquiátrica Internacional) - Puntuación Mini Mental State Examination (Mini Examen del Estado Mental) < 25 en sujetos > 0 = 50 años de edad. - En el caso de sujetos mujeres: estar embarazadas, en periodo de lactancia o tener previsto quedarse embarazadas durante la duración prevista del estudio. - Historial o evidencia clínica de enfermedad, condición médica o tratamiento que pueda poner al paciente en riesgo al participar en el estudio o pueda interferir con las evaluaciones del estudio - Cualquier circunstancia o condición que en opinión del investigador pueda afectar a que el paciente participe en el estudio o cumpla con lo requerido de él |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. The change from baseline to Month 1 in Wake After Sleep Onset (WASO) (sleep maintenance); 2. The change from baseline to Month 3 in Wake After Sleep Onset (WASO); 3. The change from baseline to Month 1 in Latency to Persistent Sleep (LPS) (sleep onset); 4. The change from baseline to Month 3 in Latency to Persistent Sleep (LPS). |
1. el cambio en el WASO (mantenimiento del sueño) desde el momento basal hasta el mes 1 2. el cambio en el WASO desde el momento basal hasta el mes 3 3. el cambio en la LPS (inicio del sueño) desde el momento basal hasta el mes 1 4. el cambio en la LPS desde el momento basal hasta el mes 3 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. From baseline to Month 1; 2. From baseline to Month 3; 3. From baseline to Month 1; 4. From baseline to Month 3. |
1. De basal al mes 1 2. De basal al mes 3 3. De basal al mes 1 4. De basal al mes 3 |
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E.5.2 | Secondary end point(s) |
1. The change from baseline to Month 1 in the subjective Total Sleep Time (sTST); 2. The change from baseline to Month 3 in the subjective Total Sleep Time (sTST); 3. The change from baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) sleepiness domain score; 4. The change from baseline to Month 3 in IDSIQ sleepiness domain score. |
• el cambio en el sTST desde el momento basala hasta el mes 1b. • el cambio en el sTST desde el momento basala hasta el mes 3c. • el cambio en la puntuación del dominio de la somnolencia IDSIQ (Insomnia Daytime Symptoms and Impacts Questionnaire) desde el momento basala hasta el mes 1b. • el cambio en la puntuación del dominio de la somnolencia IDSIQ desde el momento basala hasta el mes 3c. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. From baseline to Month 1; 2. From baseline to Month 3; 3. From baseline to Month 1; 4. From baseline to Month 3. |
1. De basal al mes 1 2. De basal al mes 3 3. De basal al mes 1 4. De basal al mes 3 |
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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 | 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 | 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) | 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 | 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 | 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 |
Australia |
Canada |
Denmark |
Germany |
Italy |
Poland |
Serbia |
Spain |
Switzerland |
United States |
|
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, intended as last telephone call for the 30-day follow-up (Visit 11) or last date of enrolment into the ID-078A303 extension study |
La última visita del último paciente, que se pretende que sea un contacto telefónico a los 30 días (visita 11) como seguimiento o la fecha correspondiente a la última inclusión en el estudio de extensión ID-078A303 |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |