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The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVT 201 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time | ||
| Wake after sleep onset |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to persistent sleep | ||
| Number of awakenings | ||
| Total wake time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James K Walsh, PhD | St. Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Petersburg Sleep Disorders Center | St. Petersburg | Florida | 33707 | United States | ||
| The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548 |
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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 |
|---|---|
| C549312 | EVT 201 |
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| Minutes of stages 1-4 and REM sleep |
| REM latency |
| Patient reported sleep variables |
| Residual sedation measures |
| Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments. |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| St. Luke's Hospital | Chesterfield (St Louis) | Missouri | 63017 | United States |
| Tri-State Sleep Disorders Center | Cincinnati | Ohio | 45246 | United States |
| D001523 |
| Mental Disorders |