Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability
Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Insomnia
Intervention: Eszopiclone (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sunovion
Summary
To assess next day driving ability and psychomotor/memory function following a single night
time dose of eszopiclone in insomnia patients.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: next day performance in a standardised test of car driving
Secondary outcome: Compensatory Tracking Task (CTT)Rapid Visual Information Processing (RVIP) Sternberg's Short-term Memory Scanning task (STM) Critical Flicker Fusion (CFF) Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
HPRU Medical Research Centre, University of Surrey, Guildford, Surrey, United Kingdom
Additional Information
Starting date: April 2005
Last updated: February 21, 2012
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