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More info
You can access this
clinical trial
if you have
Insomnia
and you are
between 18 and 64
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects. Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects with primary insomnia following single oral dosing of E2006 in the evening approximately 30 minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.

Provided treatments

  • Drug: E2006 1.0 mg
  • Drug: E2006 2.5 mg
  • Drug: E2006 5.0 mg
  • Drug: E2006 10.0 mg
  • Drug: E2006 25.0 mg
  • Drug: E2006 50.0 mg
  • Drug: E2006 100 mg
  • Drug: E2006 200 mg
  • Drug: Zolpidem 10 mg
  • Drug: E2006 Matched Placebo or Zolpidem Matched Placebo
  • Drug: E2006 Matched Placebo

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01463098. The sponsor of the trial is Eisai Inc. and it is looking for 122 volunteers for the current phase.
Official trial title:
A 2-Part, Randomized, Double-Blind, Placebo- and Active- Controlled, Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Subjects and Otherwise Healthy Subjects With Primary Insomnia