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NCT01995838 · ClinicalTrials.gov registry record · Phase 2
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 291
- Enrollment target
NCT01995838: Completed Phase 2 study, sponsored by Eisai.
NCT01995838 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 291 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (119% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01995838, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 291 participants
- Enrollment target
Study Summary
This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, parallel-group, Bayesian adaptive, dose response study in subjects with chronic insomnia. Subjects will be randomized to 1 of 6 doses of E2006 (1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg) or placebo.
Primary Outcome
The utility of a dose was a function of both Sleep Efficiency (SE) and Karolinska Sleepiness Scale (KSS), constructed by specifying the 1-dimensional component for each outcome measure and then combining them multiplicatively. Sufficient utility was defined as a probability of having utility function \>1. Probability of having utility function \>1 at the end of study visit (full analysis) was reported.
Interventions
- DRUG Placebo
- DRUG E2006
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2013-11-13 |
| Est. Completion | 2014-04-29 |
| Phase | Phase 2 |
What the finished NCT01995838 record still lists
NCT01995838 is an interventional study that assigns participants to a tested intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (119% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01995838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01995838 about?
NCT01995838 is a clinical study titled "A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia". This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, parallel-group, Bayesian adaptive, dose response study in subjects with chronic insomnia. Subjects will be randomized to 1 of 6 doses of E2006 (1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg) or placebo.
What is the current status of trial NCT01995838?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 291 participants. The study started on 2013-11-13. Estimated completion is 2014-04-29.
What interventions are being tested in trial NCT01995838?
The interventions under investigation include: Placebo (DRUG), E2006 (DRUG).
Who is sponsoring clinical trial NCT01995838?
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 NCT01995838's enrollment target sits among peer trials
291 191st of 2000 higher than 1,810 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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