A Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Criteria

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.

• 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 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.

• Nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction.

• 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.