Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability - Full Text View

Sponsor:	Sunovion
Information provided by:	Sunovion
ClinicalTrials.gov Identifier:	NCT00368056

Purpose

To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.

Condition	Intervention	Phase
Primary Insomnia	Drug: Eszopiclone Drug: Placebo	Phase III

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:	Effects of a Single Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability and Psychomotor/Memory Function in Patients With Primary Insomnia 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:	April 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (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 male and female primary insomnia patients. The medications under investigation are eszopiclone and placebo. Patients 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:	No

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
Diagnostic and statistical manual of mental disorders, defined primary insomnia
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

The use of any other medication during the study with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol. A 7-day washout period is required for any patient currently receiving prescription or non-prescription sleep medication.
Diagnosed sleep disorder or confirmed symptoms other than primary insomnia (e.g. restless leg syndrome, sleep apnoea)
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 other than primary insomnia (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
Patients 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: NCT00368056

Locations

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

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Eszopiclone Medical Director, Sunovion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00368056 History of Changes
Other Study ID Numbers:	190-060
Study First Received:	August 23, 2006
Last Updated:	November 1, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
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