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

Sponsor:	Sunovion
Information provided by:	Sunovion
ClinicalTrials.gov Identifier:	NCT00368160

Purpose

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.

Condition	Intervention	Phase
Insomnia	Drug: Eszopiclone Drug: Placebo	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Memory

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

next day performance in a standardised test of car driving [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Compensatory Tracking Task (CTT) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
Rapid Visual Information Processing (RVIP) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
Sternberg's Short-term Memory Scanning task (STM) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
Critical Flicker Fusion (CFF) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
Digit Symbol Substitution Test (DSST) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
Choice Reaction Time (CRT) [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]
Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales [ Time Frame: 9.5 hours post dose ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	March 2004
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 eszopiclone 3 mg	Drug: Eszopiclone eszopiclone 3 mg Other Names: S-Zopiclone Lunesta
Placebo Comparator: 2 Placebo tablet	Drug: Placebo Placebo tablet

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Aged between 18 and 55 years inclusive
In good health as determined by a medical history, ECG, haematology, blood and urine biochemistry and physical examination by the doctor
A body mass index greater than or equal to 18 and less than or equal to 30
Registered with a general practitioner (GP)
Hold a full current driving licence for at least one year, and be regular car drivers

Exclusion Criteria

Clinically significant use of psychotropic medication in the last three months. For example, this would include the prolonged use of antidepressants, antipsychotics, or antihistamines, but would exclude the occasional use of cold or flu remedies (which often contain antihistamines and/ or opiates)
The use of any other medication in the last two weeks with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol
Significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol)
Any subject with known hypersensitivity to any of the study treatments
A sleep/ wake cycle (e.g. shift work) liable to prejudice the results of the study
Pregnant or lactating females, and females of child bearing potential not using effective contraception
Volunteers who habitually smoke more than 5 cigarettes per day
Caffeine consumption of more than 5 cups or glasses per day
History of alcohol or drug dependence or intake of more than the equivalent of 14 units of alcohol per week for females and 21 units per week for males
Current participation in another clinical trial, or participation in a clinical trial within the last 90 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368160

Locations

United Kingdom
HPRU Medical Research Centre
Guildford, Surrey, United Kingdom

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Eszopiclone Medical Director, Sunovion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00368160 History of Changes
Other Study ID Numbers:	190-059
Study First Received:	August 23, 2006
Last Updated:	November 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

Next day driving

Additional relevant MeSH terms:

Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012