Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
- Conditions
- Insomnia Disorder
- Interventions
- Registration Number
- NCT03545191
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 930
- 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;
- 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.
- 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) only allowed if, the treatment 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daridorexant 50 mg Daridorexant 50 mg - Placebo Placebo - Daridorexant 25 mg Daridorexant 25 mg -
- Primary Outcome Measures
Name Time Method Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) From baseline to Month 1 (i.e. for up to 1 month) "Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) From baseline to Month 3 (i.e. for up to 3 months) "Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS) From baseline to Month 3 (i.e. for up to 3 months) "Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) From baseline to Month 1 (i.e. for up to 1 month) "Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST) From baseline to Month 3 (i.e. for up to 3 months) "Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score From baseline to Month 1 (i.e. for up to 1 month) The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score From baseline to Month 3 (i.e. for up to 3 months) The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST) From baseline to Month 1 (i.e. for up to 1 month) "Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Trial Locations
- Locations (81)
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Pulmonary Associates of the Southeast/WCR
🇺🇸Birmingham, Alabama, United States
Preferred Research Partners, Inc
🇺🇸Little Rock, Arkansas, United States
Woodland Research Northwest
🇺🇸Rogers, Arkansas, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
St. Francis Sleep Allergy and Lung Institute
🇺🇸Clearwater, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Hialeah, Florida, United States
Scroll for more (71 remaining)Pinnacle Research Group, LLC🇺🇸Anniston, Alabama, United States