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NCT02350309 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder

A Phase 1 study, sponsored by Eisai.

Completed
Registry status
Phase 1
Development phase
69
Enrollment target

NCT02350309 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 69 participants.

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The verdict

NCT02350309, a Phase 1 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 1
Development phase
69 participants
Enrollment target

Study Summary

This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.

Interventions

  • DRUG Lemborexant 10 mg
  • DRUG Lemborexant 5 mg
  • DRUG Lemborexant-matched placebo.
  • DRUG Flurazepam 30 mg

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2014-12-13
Est. Completion 2015-04-21
Phase Phase 1

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT02350309

The ClinicalTrials.gov registry entry for NCT02350309 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Lemborexant 10 mg is the first listed.

NCT02350309 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02350309 about?

NCT02350309 is a clinical study titled "Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder". This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.

What is the current status of trial NCT02350309?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2014-12-13. Estimated completion is 2015-04-21.

What interventions are being tested in trial NCT02350309?

The interventions under investigation include: Lemborexant 10 mg (DRUG), Lemborexant 5 mg (DRUG), Lemborexant-matched placebo. (DRUG), Flurazepam 30 mg (DRUG).

Who is sponsoring clinical trial NCT02350309?

This trial is sponsored by Eisai, which has 287 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.