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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05597020
Other study ID # ID-078A401
Secondary ID 2022-501246-30-0
Status Completed
Phase Phase 4
First received
Last updated
Start date January 18, 2023
Est. completion date April 18, 2024

Study information

Verified date May 2024
Source Idorsia Pharmaceuticals Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 18, 2024
Est. primary completion date April 15, 2024
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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. - ISIĀ© 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Germany 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
Spain 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
United States 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 Ochsner LSU Health Shreveport-Regional Urology Shreveport Louisiana
United States Encore Medical Research of Weston Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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