CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 291 enrolled
Drug / intervention
E2006 +1 moredrug
Likely dose
E2006 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01995838
NCT01995838Phase 2Completed
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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

Eisai Inc.·interventional·Posted Nov 27, 2013·Updated Jan 31, 2020

In Brief

A Phase 2 clinical trial evaluating E2006 and Placebo for Chronic Insomnia and 2 related conditions. Completed, enrolled 291 participants across 29 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Insomnia, Adults, Elderly
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 27, 2013
Enrollment StartNov 13, 2013
Primary CompletionApr 29, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.6 years ago

Interventions

E2006drug

E2006 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg, in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights

Placebodrug

E2006-matched placebo in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights