A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia
NCT ID: NCT05597020
Last Updated: 2025-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2023-02-16
2024-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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50 mg daridorexant
Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed.
Daridorexant
Daridorexant is available as oral film-coated tablets at a strength of 50 mg.
Placebo
Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed.
Placebo
Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.
Interventions
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Daridorexant
Daridorexant is available as oral film-coated tablets at a strength of 50 mg.
Placebo
Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.
Eligibility Criteria
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Inclusion Criteria
* 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.
* Insomnia Severity Index© (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
* Planned travel across ≥ 3 time zones during study.
* Life time history of suicidality assessed via Columbia Suicide Severity Rating Scale© (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 rapid eye movement (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.
55 Years
ALL
No
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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Quantum Clinical Trials
Miami Beach, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Encore Medical Research of Weston
Weston, Florida, United States
Ochsner LSU Health Shreveport-Regional Urology
Shreveport, Louisiana, United States
Accellacare Research of Cary
Cary, North Carolina, United States
Praxisklinik am Franziskushospital - Urologisches Zentrum Euregio
Aachen, , Germany
ASR Advanced Sleep Research GmBH
Berlin, , Germany
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, , Germany
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital del Mar
Barcelona, , Spain
UROCLINICA Barcelona
Barcelona, , Spain
Hospital Universitario Puerta del Mar (HUPM)
Cadiz, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospitalario Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-501246-30-00
Identifier Type: OTHER
Identifier Source: secondary_id
ID-078A401
Identifier Type: -
Identifier Source: org_study_id
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