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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 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 291 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG E2006

Trial Details

FieldValue
Enrollment Target 291 participants
Start Date 2013-11-13
Est. Completion 2014-04-29
Phase Phase 2

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT01995838

The ClinicalTrials.gov registry entry for NCT01995838 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 291 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 2 interventions - of which Placebo is the first listed.

NCT01995838 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.