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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | eszopiclone 3 mg |
|
| 2 | Placebo Comparator | Placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone | Drug | eszopiclone 3 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| next day performance in a standardised test of car driving | 9.5 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Compensatory Tracking Task (CTT) | 9.5 hours post dose | |
| Rapid Visual Information Processing (RVIP) | 9.5 hours post dose | |
| Sternberg's Short-term Memory Scanning task (STM) |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HPRU Medical Research Centre | Guildford | Surrey | United Kingdom |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Placebo | Drug | Placebo tablet |
|
| 9.5 hours post dose |
| Critical Flicker Fusion (CFF) | 9.5 hours post dose |
| Digit Symbol Substitution Test (DSST) | 9.5 hours post dose |
| Choice Reaction Time (CRT) | 9.5 hours post dose |
| Leeds Sleep Evaluation Questionnaire and Leeds Analogue Rating Scales | 9.5 hours post dose |
| D001523 |
| Mental Disorders |
| D011725 |
| Pyridines |