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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Nocturia; Insomnia Disorder
• Intervention / Treatment: Drug: Daridorexant; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Idorsia Clinical Trials Information; Phone Number: +1 856 66 13 721; Email: idorsiaclinicaltrials@idorsia.com

Study Locations

• Germany
  • Aachen, Germany, 52064
    • Praxisklinik am Franziskushospital - Urologisches Zentrum Euregio
  • Berlin, Germany, 10117
    • ASR Advanced Sleep Research GmBH
  • Schwerin, Germany, 19053
    • SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 08006
    • UROCLINICA Barcelona
  • Cadiz, Spain, 11009
    • Hospital Universitario Puerta del Mar (HUPM)
  • Madrid, Spain, 28040
    • Hospital Universitario Fundación Jiménez Díaz
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • San Cristóbal de La Laguna, Spain, 38320
    • Hospitalario Universitario de Canarias
• United States
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Quantum Clinical Trials
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center of Florida
    • Weston, Florida, United States, 33331
      • Encore Medical Research of Weston
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Ochsner LSU Health Shreveport-Regional Urology
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Accellacare Research of Cary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 mg daridorexant; Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed.	Drug: Daridorexant; Daridorexant is available as oral film-coated tablets at a strength of 50 mg.
Placebo Comparator: Placebo; Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed.	Drug: Placebo; Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Investigators: Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Actual): April 15, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Sleep Initiation and Maintenance Disorders; Nocturia
• Other Study ID Numbers: ID-078A401; 2022-501246-30-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No