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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: Completed Phase 1 study, sponsored by Eisai.
NCT02350309 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The multiple sleep latency test (MSLT) is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four Sleep Latency Tests (SLTs), with the first starting at 45 minutes after morning wake time, and the subsequ
Interventions
- DRUG Lemborexant 10 mg
- DRUG Lemborexant 5 mg
- DRUG Lemborexant-matched placebo.
- DRUG Flurazepam 30 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2014-12-13 |
| Est. Completion | 2015-04-21 |
| Phase | Phase 1 |
What the finished NCT02350309 record still lists
NCT02350309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 4 interventions - of which Lemborexant 10 mg is the first listed.
NCT02350309 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02350309's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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