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

Sponsor
Idorsia Pharmaceuticals Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05597020
Collaborator
(none)
50
Enrollment
6
Locations
2
Arms
4.4
Anticipated Duration (Months)
8.3
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This is a multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over post-approval study.This is a multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over post-approval study.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Jun 29, 2023
Anticipated Study Completion Date :
Jun 29, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline to Week 4 in subjective total sleep time (sTST) [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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  • Nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction.

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Bernardino Urological Associates Medical Group San Bernardino California United States 92404
2 Urology Research Network Hialeah Florida United States 33016
3 Clinical Research Center of Florida Pompano Beach Florida United States 33060
4 Ochsner LSU Health Shreveport-Regional Urology Shreveport Louisiana United States 71106
5 Columbia University Irving Medical Center New York New York United States 10032
6 Accellacare Research of Cary Cary North Carolina United States 27518

Sponsors and Collaborators

  • Idorsia Pharmaceuticals Ltd.

Investigators

  • Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT05597020
Other Study ID Numbers:
  • ID-078A401
  • 2022-501246-30-00
First Posted:
Oct 27, 2022
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Nocturia

Study Results

No Results Posted as of Jan 31, 2023