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NCT02839200 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

A Phase 2 study, sponsored by Idorsia Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
360
Enrollment target

NCT02839200: Completed Phase 2 study, sponsored by Idorsia Pharmaceuticals.

NCT02839200 is a Phase 2 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 360 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (171% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02839200, a Phase 2 study, has completed, sponsored by Idorsia Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
360 participants
Enrollment target

Study Summary

This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.

Primary Outcome

WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)

Interventions

  • DRUG Placebo 1
  • DRUG Zolpidem
  • DRUG ACT-541468 5 mg
  • DRUG ACT-541468 10 mg
  • DRUG ACT-541468 25 mg

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2016-10-04
Est. Completion 2017-06-20
Phase Phase 2
Idorsia Pharmaceuticals

34 total trials

What the finished NCT02839200 record still lists

NCT02839200 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (171% higher).

The record links to 0 conditions, and to 5 interventions - of which Placebo 1 is the first listed.

NCT02839200 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02839200 about?

NCT02839200 is a clinical study titled "Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder". This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.

What is the current status of trial NCT02839200?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2016-10-04. Estimated completion is 2017-06-20.

What interventions are being tested in trial NCT02839200?

The interventions under investigation include: Placebo 1 (DRUG), Zolpidem (DRUG), ACT-541468 5 mg (DRUG), ACT-541468 10 mg (DRUG), ACT-541468 25 mg (DRUG).

Who is sponsoring clinical trial NCT02839200?

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

How this trial's enrollment target compares

Where NCT02839200's enrollment target sits among peer trials

360 123rd of 2000 higher than 1,874 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02839200, the US trial registry maintained by the National Library of Medicine. NCT02839200 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.