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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 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 63 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03001557
The ClinicalTrials.gov registry entry for NCT03001557 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 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 5 interventions - of which Lemborexant 10 mg is the first listed.
NCT03001557 reports 0 study locations.
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.
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