A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia
Completed · Phase 4 · Has a placebo group
Conditions studied: Insomnia Disorder, Nocturia
In brief
A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia
Key facts
- Study ID
- NCT05597020
- Run by
- Idorsia Pharmaceuticals Ltd.
- People needed
- 60
- Starts
- 2023-02-16
- Expected to finish
- 2024-04-18
- Last updated by the study team
- 2025-04-18
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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