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NCT03008447 · ClinicalTrials.gov registry record · Phase 1

Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older

A Phase 1 study of Healthy Subjects, sponsored by Eisai.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
4
Study locations

NCT03008447 is a Phase 1 study of Healthy Subjects that has completed, run by Eisai. The registered enrollment target is 60 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (53% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT03008447, a Phase 1 study of Healthy Subjects, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
4
Study locations

Study Summary

E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose administration at bedtime.

Conditions Studied

Healthy Subjects

Interventions

  • DRUG LEM5
  • DRUG LEM10
  • DRUG ZOL
  • DRUG PBO

Study Locations (4)

Georgia

  • NeuroTrials Research, Inc - Atlanta

New York

  • Clinilabs, Inc - New York

North Carolina

  • Wake Research Assoicates, LLC - Raleigh

Ohio

  • Community Research Management Associates d/b/a CTI Clinical Research Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2016-11-21
Est. Completion 2018-01-03
Phase Phase 1

Sponsor

Eisai

287 total trials

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What the Registry Record Tells You About NCT03008447

The ClinicalTrials.gov registry entry for NCT03008447 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (53% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 4 interventions - of which LEM5 is the first listed.

NCT03008447 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Georgia, New York, North Carolina.

Frequently Asked Questions

What is clinical trial NCT03008447 about?

NCT03008447 is a clinical study titled "Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older". E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a...

What is the current status of trial NCT03008447?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2016-11-21. Estimated completion is 2018-01-03.

What conditions does trial NCT03008447 study?

This clinical trial studies the following conditions: Healthy Subjects.

What interventions are being tested in trial NCT03008447?

The interventions under investigation include: LEM5 (DRUG), LEM10 (DRUG), ZOL (DRUG), PBO (DRUG).

Who is sponsoring clinical trial NCT03008447?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03008447 being conducted?

This trial has 4 study locations across Georgia, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.