Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability
This study has been completed.
Sponsor:
Sunovion
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00368056
First received: August 23, 2006
Last updated: February 21, 2012
Last verified: February 2012
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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 3 |
| 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:
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:
|
|
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 More Information
No publications provided
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00368056 History of Changes |
| Other Study ID Numbers: | 190-060 |
| Study First Received: | August 23, 2006 |
| Last Updated: | February 21, 2012 |
| 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 May 21, 2013