Nocturia Clinical Trial
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
Verified date | May 2024 |
Source | Idorsia Pharmaceuticals Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A post approval study to investigate the efficacy of daridorexant in subjects with insomnia and comorbid nocturia
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Idorsia Pharmaceuticals Ltd. |
United States, Germany, Spain,
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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