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NCT04009577 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 53
- Enrollment target
NCT04009577: Completed Phase 3 study, sponsored by Eisai.
NCT04009577 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 53 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04009577, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 53 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the proportion of adult \[greater than or equal to (\>=) 18 years\] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate extended release (ZOL-ER), intermittently or frequently, who transition to lemborexant 5 milligram (mg) (LEM5) or 10 mg (LEM10) after 2 weeks of receiving LEM.
Primary Outcome
Transition to LEM was defined as participant who remained on LEM at the end of the 2-week titration period and either 1) entered the extension phase, or 2) chooses to not enter the extension phase for reasons not related to LEM (including, but not limited to, time commitment related to the study, study-related travel expenses or preference to continue insomnia management with another health care provider).
Interventions
- DRUG LEM 5 mg
- DRUG LEM 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2020-06-26 |
| Phase | Phase 3 |
What the finished NCT04009577 record still lists
NCT04009577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which LEM 5 mg is the first listed.
NCT04009577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04009577 about?
NCT04009577 is a clinical study titled "A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia". The primary objective of the study is to evaluate the proportion of adult \[greater than or equal to (\>=) 18 years\] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate extended release (ZOL-ER), intermittently or frequently, who transition t...
What is the current status of trial NCT04009577?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2019-07-15. Estimated completion is 2020-06-26.
What interventions are being tested in trial NCT04009577?
The interventions under investigation include: LEM 5 mg (DRUG), LEM 10 mg (DRUG).
Who is sponsoring clinical trial NCT04009577?
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 NCT04009577's enrollment target sits among peer trials
53 1839th of 2000 higher than 160 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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