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NCT05423717 · ClinicalTrials.gov registry record · Phase 2

Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

A Phase 2 study, sponsored by Idorsia Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
166
Enrollment target

NCT05423717 is a Phase 2 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 166 participants.

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The verdict

NCT05423717, a Phase 2 study, has completed, sponsored by Idorsia Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
166 participants
Enrollment target

Study Summary

This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to \< 18 years with insomnia disorder.

Interventions

  • DRUG Placebo
  • DRUG Daridorexant 50 mg
  • DRUG Daridorexant 25 mg
  • DRUG Daridorexant 10 mg

Trial Details

FieldValue
Enrollment Target 166 participants
Start Date 2022-09-06
Est. Completion 2026-02-05
Phase Phase 2

Sponsor

Idorsia Pharmaceuticals

34 total trials

What the Registry Record Tells You About NCT05423717

The ClinicalTrials.gov registry entry for NCT05423717 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Idorsia Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT05423717 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05423717 about?

NCT05423717 is a clinical study titled "Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder". This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to \< 18 years with insomnia disorder.

What is the current status of trial NCT05423717?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2022-09-06. Estimated completion is 2026-02-05.

What interventions are being tested in trial NCT05423717?

The interventions under investigation include: Placebo (DRUG), Daridorexant 50 mg (DRUG), Daridorexant 25 mg (DRUG), Daridorexant 10 mg (DRUG).

Who is sponsoring clinical trial NCT05423717?

This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.