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 - ID-078A401

Idorsia Pharmaceuticals Ltd.0 个研究点目标入组 50 人开始时间: 2022年10月26日最近更新: 2024年7月22日

试验速览

暂无简介。

•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., 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.

•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, and central or nephrogenic diabetes insipidus, and primary/secondary polydipsia within the last 6 months prior to Visit 1., 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.

发起方