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NCT03001557 · ClinicalTrials.gov registry record · Phase 2
Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT03001557: Completed Phase 2 study, sponsored by Eisai.
NCT03001557 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03001557, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
This study will be conducted to determine the dose response of lemborexant (LEM) on the change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters, and circadian-rhythm related parameters. Following the eligibility screening period, eligible participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks. After a 2-week follow-up period, eligible participants may enter an open-label extension period for up to 30 months or until the program discontinuation.
Primary Outcome
aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to
Interventions
- DRUG Lemborexant 10 mg
- DRUG Lemborexant-matched placebo
- DRUG Lemborexant 2.5 mg
- DRUG Lemborexant 5 mg
- DRUG Lemborexant 15 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2016-12-20 |
| Est. Completion | 2020-04-17 |
| Phase | Phase 2 |
What the finished NCT03001557 record still lists
NCT03001557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 5 interventions - of which Lemborexant 10 mg is the first listed.
NCT03001557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03001557 about?
NCT03001557 is a clinical study titled "Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia". This study will be conducted to determine the dose response of lemborexant (LEM) on the change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters, and circadian-rhythm related parameters. Following the eligibility screening period, eligible participants will be ass...
What is the current status of trial NCT03001557?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2016-12-20. Estimated completion is 2020-04-17.
What interventions are being tested in trial NCT03001557?
The interventions under investigation include: Lemborexant 10 mg (DRUG), Lemborexant-matched placebo (DRUG), Lemborexant 2.5 mg (DRUG), Lemborexant 5 mg (DRUG), Lemborexant 15 mg (DRUG).
Who is sponsoring clinical trial NCT03001557?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03001557's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 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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