A Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia

Study Overview
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Brief Summary
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A post approval study to investigate the efficacy of daridorexant in subjects with insomnia and comorbid nocturia

Official Title
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A Multi-center, Double-blind, Randomized, Placebo-controlled, 2-way Cross-over Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia

Conditions
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Nocturia, Insomnia Disorder

Intervention / Treatment
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* Drug: Daridorexant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated ICF prior to any study-mandated procedure. Male or female subjects ≥ 55 years old at the time of signing the ICF. Insomnia complaints for at least 3 months prior to Visit 1. ISI© score ≥ 13 at Visit 1. Nocturia severity: on average ≥ 3 nocturnal voids per night reported by the subjects for at least 1 month prior to Visit 1. Ability to communicate well with the investigator, to understand the study requirements and judged by the investigator to be alert and oriented to person, place, time, and situation. Exclusion Criteria: Woman of childbearing potential, pregnant or plans to become pregnant. Planned travel across ≥ 3 time zones during study. Life time history of suicidality assessed via C-SSRS. Regular caffeine consumption after 4 pm. Unable to refrain from smoking during the night. Known and documented diagnosis of narcolepsy, periodic limb movement disorder, moderate to severe obstructive sleep apnea, restless legs syndrome, circadian rhythm sleep-wake disorder, or REM sleep behavior disorder. Known and documented diagnosis of Type 1 diabetes mellitus, uncontrolled Type 2 diabetes mellitus, central or nephrogenic diabetes insipidus, and primary/secondary polydipsia. Known and documented nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction within the last 6 months prior to Visit 1. Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over post-approval study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg daridorexant<br>Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed. | Drug: Daridorexant<br>* Daridorexant is available as oral film-coated tablets at a strength of 50 mg.<br>|
| Placebo Comparator: Placebo<br>Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed. | Drug: Placebo<br>* Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 4 in subjective total sleep time (sTST) | Baseline is the mean value based on the screening sleep diary for sTST, performed on the 7 days preceding randomization. Week 4 is the mean value based on the sleep diary entries for sTST performed on study days 23-29 of each treatment period. | From baseline to Week 4 (i.e., up to 5 weeks) per treatment period. Total duration (incl. 2 to 3-week washout): approximately 3.5 months. |