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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Insomnia Disorder; Nocturia

Treatments: Drug: Placebo; Drug: Daridorexant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05597020

ID-078A401

2022-501246-30-00 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

50 mg daridorexant

Experimental group

Description:

Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed.

Treatment:

Drug: Daridorexant

Placebo

Placebo Comparator group

Description:

Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed.

Treatment:

Drug: Placebo