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

NCT05597020 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: ID-078A4012022-501246-30-00
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 16

Brief Summary

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

Conditions

Insomnia Disorder; Nocturia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 4 in sTST

  Subjective total sleep time (sTST) is the total sleep time reported by the subject in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. Baseline is the mean value based on the subject's sleep diary entries for sTST on the 7 days preceding randomization. Week 4 is the mean value based on the subject's sleep diary entries for sTST on study days 23-29 of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).

  From baseline to Week 4 per treatment period.

Other Outcomes (1)

• Change From Baseline to Week 4 in Number of Nocturnal Voids Assessed Using a Voiding Diary

  From baseline to Week 4 per treatment period.

Study Arms (2)

50 mg daridorexant

EXPERIMENTAL

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

Drug: Daridorexant

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Daridorexant DRUG

Daridorexant is available as oral film-coated tablets at a strength of 50 mg.

50 mg daridorexant

Placebo DRUG

Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (16)

Quantum Clinical Trials

Miami Beach, Florida, 33140, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Encore Medical Research of Weston

Weston, Florida, 33331, United States

Location

Ochsner LSU Health Shreveport-Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Accellacare Research of Cary

Cary, North Carolina, 27518, United States

Location

Praxisklinik am Franziskushospital - Urologisches Zentrum Euregio

Aachen, 52064, Germany

Location

ASR Advanced Sleep Research GmBH

Berlin, 10117, Germany

Location

SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, 19053, Germany

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

UROCLINICA Barcelona

Barcelona, 08006, Spain

Location

Hospital Universitario Puerta del Mar (HUPM)

Cadiz, 11009, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospitalario Universitario de Canarias

San Cristóbal de La Laguna, 38320, Spain

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Nocturia

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Idorsia Clinical Trial Information
• Organization: Idorsia Pharmaceuticals Ltd

idorsiaclinicaltrials@idorsia.com

+1 856 661 3721

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over post-approval study.

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 27, 2022
• Study Start: February 16, 2023
• Primary Completion: April 12, 2024
• Study Completion: April 18, 2024
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8); US (5); DE (3)