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COMPLETED Phase 4

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

NCT05597020 · View on ClinicalTrials.gov ↗

Study Summary

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

Interventions

  • DRUG Placebo
  • DRUG Daridorexant

Study Locations (16)

Other

  • Praxisklinik am Franziskushospital - Urologisches Zentrum Euregio — Aachen
  • ASR Advanced Sleep Research GmBH — Berlin
  • SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH — Schwerin
  • Complejo Hospitalario Universitario A Coruña — A Coruña
  • Hospital del Mar — Barcelona
  • UROCLINICA Barcelona — Barcelona
  • Hospital Universitario Puerta del Mar (HUPM) — Cadiz
  • Hospital Universitario Fundación Jiménez Díaz — Madrid
  • Hospital Universitario La Paz — Madrid
  • Hospital Universitario Central de Asturias — Oviedo
  • Hospitalario Universitario de Canarias — San Cristóbal de La Laguna

Florida

  • Quantum Clinical Trials — Miami Beach
  • Clinical Research Center of Florida — Pompano Beach
  • Encore Medical Research of Weston — Weston

Louisiana

  • Ochsner LSU Health Shreveport-Regional Urology — Shreveport

North Carolina

  • Accellacare Research of Cary — Cary

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2023-02-16
Est. Completion 2024-04-18
Phase Phase 4

Sponsor

Idorsia Pharmaceuticals

38 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05597020

The ClinicalTrials.gov registry entry for NCT05597020 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Idorsia Pharmaceuticals, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Nocturia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05597020 reports 16 study locations spanning 4 distinct geographic areas — top geographies include Other, Florida, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05597020 about?

NCT05597020 is a clinical study titled "A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia". A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia

What is the current status of trial NCT05597020?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2023-02-16. Estimated completion is 2024-04-18.

What conditions does trial NCT05597020 study?

This clinical trial studies the following conditions: Nocturia, Insomnia Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05597020?

The interventions under investigation include: Placebo (DRUG), Daridorexant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05597020?

This trial is sponsored by Idorsia Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05597020 being conducted?

This trial has 16 study locations across Florida, Louisiana, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial