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The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating elderly patients diagnosed with primary insomnia who also have moderate daytime sleepiness.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVT 201 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography derived Total Sleep Time averaged over nights 1, 6 and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Multiple Sleep Latency Test at Day 8 | ||
| Mean Psychomotor Vigilance Task at Day 8 | ||
| Mean Karolinska Sleepiness Scale at Day 8 |
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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 |
|---|---|---|---|---|---|---|
| PsyPharma Clinical Research Inc. | Phoenix | Arizona | 85050 | United States | ||
| PsyPharma Clinical Research, Inc. |
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| Mean Rey Auditory Verbal Learning Test at Day 8 |
| Mean Profile of Mood State at Day 8 |
| Polysomnography derived variables averaged over nights 1, 6 and 7 |
| Patient reported evaluations of sleep quality and quantity over nights 1 to 7 |
| Benzodiazepine withdrawal questionnaire at baseline and follow-up |
| Safety including adverse events, ECGs, vital signs, routine laboratory tests throughout the study |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Pacific Sleep Medicine Services Inc | Los Angeles | California | 90048 | United States |
| Pacific Sleep Medicine Services | San Diego | California | 92121 | United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| OmniTrials, 11181 Health Park Blvd, Suite 3040 | Naples | Florida | 34110 | United States |
| Broward Research Group | Pembroke Pines | Florida | 33026 | United States |
| Clinical Research Group of St Petersburg Inc., 2525 Pasadena Ave So, Suite S | St. Petersburg | Florida | 33707 | United States |
| The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center, 5505 Peachtree Dunwoody Road, Suite 548 | Atlanta | Georgia | 30342 | United States |
| Sleep Disorders Center of Georgia - Gainesville | Gainesville | Georgia | 30501 | United States |
| Vince and Assocaites Clinical Research | Overland Park | Kansas | 66212 | United States |
| Community Research | Crestview Hills | Kentucky | 41017 | United States |
| Center for Sleep Medicine, 101 Courtney Circle | Hattiesburg | Mississippi | 39402 | United States |
| Sleep Medicine and Research Center, 232 S. Woods Mill Road | Chesterfield (St Louis) | Missouri | 63017 | United States |
| Clinilabs, Inc., 423 West 55th Street, 4th Floor | New York | New York | 10019 | United States |
| Duke Insomnia and Sleep Research, Duke South Hospital, Room 54242, Trent Drive | Durham | North Carolina | 27710 | United States |
| Community Research | Cincinnati | Ohio | 45227 | United States |
| Tri-State Sleep Disorders Center, 1275 East Kemper Road | Cincinnati | Ohio | 45246 | United States |
| Bradley Hospital Sleep Research Laboratory, 300 Duncan Drive | Providence | Rhode Island | 02906 | United States |
| Sleep Disorders Center, 1333 Taylor Street, Suite 5A | Columbia | South Carolina | 29201 | United States |
| Sleep Medicine Associates p.a., 5477 Glen Lakes Drive, Suite 125 | Dallas | Texas | 75231 | United States |
| Baylor College of Medicine, VAMC-Sleep Laboratory, 2002 Holcombe Boulevard , Room 6C-344 | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C549312 | EVT 201 |
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