Study of an Evening Dose of Eszopiclone on Next Day Driving Ability & Psychomotor/Memory Function in Healthy Volunteers

Insomnia Clinical Trial

Official title: The Effects of a Single Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability and Psychomotor/Memory Function in Healthy Volunteers Compared to Placebo

Status Completed

Clinical Trial Summary

Male and female healthy volunteers. Patients must also possess a full current driving license (for at least one year), and be a regular car driver.

Clinical Trial Description

The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 healthy male and female volunteers. The medications under investigation are eszopiclone and placebo. Volunteers will receive the study medications and placebo on the evening of Day 2 of each treatment period. Performance will be assessed on Day 3 of each treatment period. Each treatment period will be separated by at least a 7-day washout period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

• NCT number: NCT00368160
• Study type: Interventional
• Source: Sunovion
• Status: Completed
• Phase: Phase 1
• Start date: March 2004
• Completion date: July 2005