Clinical Trials Logo
  1. Home
  2. Insomnia
  3. NCT01463098

A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006

Insomnia Clinical Trial

Official 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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Clinical Trial Details
NCT number NCT01463098
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 1
Start date October 5, 2011
Completion date August 11, 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05963542 - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia N/A
Completed NCT06339853 - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia N/A
Recruiting NCT04069247 - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia N/A
Completed NCT04493593 - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility N/A
Recruiting NCT06278077 - Neurexan - a Clinical Trial in Short-Term Insomnia Patients Phase 2
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Recruiting NCT06207279 - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting NCT06006299 - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC) N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04035200 - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation Phase 2
Active, not recruiting NCT05027438 - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention N/A
Recruiting NCT06053840 - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia Phase 4
Not yet recruiting NCT06348082 - Project Women's Insomnia Sleep Health Equity Study (WISHES) N/A
Not yet recruiting NCT06363799 - Osteopathic Protocol for Insomnia in College Students N/A
Not yet recruiting NCT06025968 - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis N/A
Not yet recruiting NCT05991492 - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application N/A