Insomnia disorder MedDRA version: 20.0 Level: PT Classification code 10022437 Term: Insomnia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
Idorsia Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 540 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 360
Exclusion criteria
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 = 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 25 mg and 50 mg ACT-541468 on objective sleep parameters in subjects with insomnia disorder.;Secondary Objective: - 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.;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).;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;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. | — |
Countries
Australia, Canada, Denmark, Germany, Italy, Poland, Serbia, Spain, Switzerland, United States
Contacts
Public ContactClinical Trial Disclosure Desk
Idorsia Pharmaceuticals Ltd
Outcome results
None listed