E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 |
|
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 10 mg and 25 mg ACT-541468 on objective sleep parameters in subjects with insomnia disorder. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of 10 mg and 25 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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed informed consent prior to any study-mandated procedure; - Male or female aged ≥ 18 years; - Insomnia disorder according to DSM-5 criteria; - Insomnia Severity Index score ≥ 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. |
|
E.4 | Principal exclusion criteria |
- Body mass index below 18.5 or above 40.0 kg/m2; - Any lifetime history of of 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 ≥ 1 hour per day and ≥ 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 ≥ 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. |
|
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). |
|
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. |
|
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. |
|
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. |
|
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 |
|
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
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 |
Belgium |
Bulgaria |
Canada |
Czech Republic |
Finland |
France |
Germany |
Hungary |
Sweden |
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 |
|
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 |