Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability

Primary Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368056
• Other study ID #: 190-060
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2006
• Last updated: February 21, 2012
• Start date: April 2005
• Est. completion date: June 2006

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

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

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Eszopiclone
eszopiclone 3 mg
• Placebo
Placebo tablet

Locations

Country	Name	City	State
United Kingdom	HPRU Medical Research Centre, University of Surrey	Guildford	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	next day performance in a standardised test of car driving		9.5 hours post dose	Yes
Secondary	Compensatory Tracking Task (CTT)		9.5 hours post dose	No
Secondary	Rapid Visual Information Processing (RVIP)		9.5 hours post dose	No
Secondary	Sternberg's Short-term Memory Scanning task (STM)		9.5 hours post dose	No
Secondary	Critical Flicker Fusion (CFF)		9.5 hours post dose	No
Secondary	Digit Symbol Substitution Test (DSST)		9.5 hours post dose	No
Secondary	Choice Reaction Time (CRT)		9.5 hours post dose	No
Secondary	Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales		9.5 hours post dose	No