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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05597020
• Other study ID #: ID-078A401
• Secondary ID: 2022-501246-30-0
• Status: Completed
• Phase: Phase 4
• Start date: January 18, 2023
• Est. completion date: April 18, 2024

Study information

• Verified date: May 2024
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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.

• 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, 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.

Related Conditions & MeSH terms

• Insomnia Disorder
• Nocturia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Daridorexant
Daridorexant is available as oral film-coated tablets at a strength of 50 mg.
• Placebo
Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

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.