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

Phase 4

Completed

• Conditions: Insomnia Disorder; Nocturia

• Registration Number: 2022-501246-30-00
• Lead Sponsor: Idorsia Pharmaceuticals Ltd., Idorsia Pharmaceuticals Ltd.

Brief Summary

To assess whether daridorexant improves insomnia in subjects with insomnia and comorbid nocturia.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2023-03-02
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: Ended
• Sex: Not specified
• Target Recruitment: 35

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, 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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline to Week 4 in subjective total sleep time (sTST).		Change from baseline to Week 4 in subjective total sleep time (sTST).

Trial Locations

Locations (13)

Complexo Hospitalario Universitario A Coruna; 🇪🇸 A Coruna, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta Del Mar; 🇪🇸 Cadiz, Spain

Uroclinica Barcelona SLP; 🇪🇸 Barcelona, Spain

University Hospital Of Canary Islands; 🇪🇸 San Cristobal De La Laguna, Spain

Hospital Universitario Central De Asturias; 🇪🇸 Oviedo, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Gemeinschaftspraxis Michael Berse & Hans Schippel; 🇩🇪 Duisburg, Germany

Urologicum Duisburg; 🇩🇪 Duisburg, Germany

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Complexo Hospitalario Universitario A Coruna

🇪🇸A Coruna, Spain

Jose Maria Sanchez Merino

Site contact

981178000

Jose.Maria.Sanchez.Merino@sergas.es