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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: Completed Phase 1 study of Healthy Subjects, sponsored by Eisai.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Magnitude of body sway upon being awakened at approximately 4 hours after receiving lemborexant 5 milligrams (mg) (LEM5), lemborexant 10 mg (LEM10), zolpidem 6.25 mg, or placebo.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-11-21 |
| Est. Completion | 2018-01-03 |
| Phase | Phase 1 |
What the finished NCT03008447 record still lists
NCT03008447 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (53% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03008447's enrollment target sits among peer trials
60 22nd of 69 higher than 47 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects 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.
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