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The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness. Subjects will be randomized to either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | ABT-652 Dose 1 vs placebo capsules administered orally once daily for 7 days |
|
| Arm 2 | Experimental | ABT-652 Dose 2 vs placebo capsules administered orally once daily for 7 days |
|
| Arm 3 | Experimental | ABT-652 Dose 3 vs placebo capsules administered orally once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-652 | Drug | See arm description for details |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory Tests | Baseline period to end of 1-week treatment period. | |
| ECG | Baseline period to end of 1-week treatment period. | |
| Adverse Events | Baseline period till 30 days after the last dose. | |
| Vital Signs | Baseline period to end of 1-week treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance Wakefulness Test | Baseline period to end of 1-week treatment period. |
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Inclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 43241 | Phoenix | Arizona | 85006 | United States | ||
| Site Reference ID/Investigator# 38092 |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
See arm description for details |
|
| Glendale |
| California |
| 91206 |
| United States |
| Site Reference ID/Investigator# 43264 | San Diego | California | 92103 | United States |
| Site Reference ID/Investigator# 40402 | New York | New York | 10019 | United States |
| Site Reference ID/Investigator# 38122 | Durham | North Carolina | 27710 | United States |
| D001523 | Mental Disorders |