Clinical trial NCT05597020: A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia Disorder
Nocturia
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over post-approval study.
Primary purpose: TREATMENT

Brief summary: A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent form (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.
* 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:

* 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 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.

Primary outcomes:
measure: Change From Baseline to Week 4 in sTST
timeFrame: From baseline to Week 4 per treatment period.
Secondary outcomes:
Other outcomes:
measure: Change From Baseline to Week 4 in Number of Nocturnal Voids Assessed Using a Voiding Diary
timeFrame: From baseline to Week 4 per treatment period.
Locations:
city: Miami Beach
country: United States
facility: Quantum Clinical Trials
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Weston
country: United States
facility: Encore Medical Research of Weston
state: Florida
city: Shreveport
country: United States
facility: Ochsner LSU Health Shreveport-Regional Urology
state: Louisiana
city: Cary
country: United States
facility: Accellacare Research of Cary
state: North Carolina
city: Aachen
country: Germany
facility: Praxisklinik am Franziskushospital - Urologisches Zentrum Euregio
city: Berlin
country: Germany
facility: ASR Advanced Sleep Research GmBH
city: Schwerin
country: Germany
facility: SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: UROCLINICA Barcelona
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar (HUPM)
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: San Cristóbal de La Laguna
country: Spain
facility: Hospitalario Universitario de Canarias
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: