A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

Phase 4

Completed

• Conditions: Insomnia Disorder; Nocturia
• Interventions: Drug: Daridorexant; Drug: Placebo

• Registration Number: NCT05597020
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-27
• Study Start: 2023-02-16
• Primary Completion: 2024-04-12
• Study Completion: 2024-04-18
• Status Verified: 2025-04
• Results First Submitted: 2025-04-01
• Results First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Results First Posted: 2025-04-18
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
50 mg daridorexant	Daridorexant	Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed.
Placebo	Placebo	Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 4 in sTST	From baseline to Week 4 per treatment period.	Subjective total sleep time (sTST) is the total sleep time reported by the subject in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST.; Baseline is the mean value based on the subject's sleep diary entries for sTST on the 7 days preceding randomization.; Week 4 is the mean value based on the subject's sleep diary entries for sTST on study days 23-29 of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).

Trial Locations

Locations (16)

Accellacare Research of Cary; 🇺🇸 Cary, North Carolina, United States

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

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

UROCLINICA Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta del Mar (HUPM); 🇪🇸 Cadiz, Spain

Hospital Universitario Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Praxisklinik am Franziskushospital - Urologisches Zentrum Euregio; 🇩🇪 Aachen, Germany

Hospital del Mar; 🇪🇸 Barcelona, Spain

Ochsner LSU Health Shreveport-Regional Urology; 🇺🇸 Shreveport, Louisiana, United States

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Hospitalario Universitario de Canarias; 🇪🇸 San Cristóbal de La Laguna, Spain