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The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 2680, 10 mg | Experimental | Oral tablet containing 10mg of ALKS 2680 for once daily administration |
|
| ALKS 2680, 14 mg | Experimental | Oral tablet containing 14mg of ALKS 2680 for once daily administration |
|
| ALKS 2680, 18 mg | Experimental | Oral tablet containing 18mg of ALKS 2680 for once daily administration |
|
| Placebo | Placebo Comparator | Oral tablet containing matching placebo for once daily administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 2680 | Drug | Oral tablet containing ALKS 2680 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT) | Baseline to Week 8 | |
| Change in Epworth Sleepiness Scale (ESS) | Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days. | Baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 21 weeks |
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Inclusion Criteria:
Additionally, meets the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigator Site | Little Rock | Arkansas | 72211 | United States | ||
| Alkermes Investigator Site |
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| Label | URL |
|---|---|
| Vibrance-2 Study | View source |
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| Placebo | Drug | Oral tablet containing placebo for once daily administration |
|
| Los Angeles |
| California |
| 90025 |
| United States |
| Alkermes Investigator Site | Redwood City | California | 94063 | United States |
| Alkermes Investigator Site | San Francisco | California | 94143 | United States |
| Alkermes Investigator Site | Santa Ana | California | 92705 | United States |
| Alkermes Investigational Site | Aurora | Colorado | 80045 | United States |
| Alkermes Investigator Site | Colorado Springs | Colorado | 80918 | United States |
| Alkermes Investigator Site | Brandon | Florida | 33511 | United States |
| Alkermes Investigator Site | Miami | Florida | 33176 | United States |
| Alkermes Investigator Site | Winter Park | Florida | 32789 | United States |
| Alkermes Investigator Site | Atlanta | Georgia | 30328 | United States |
| Alkermes Investigational Site | Macon | Georgia | 31210 | United States |
| Alkermes Investigator Site | Stockbridge | Georgia | 30281 | United States |
| Alkermes Investigational Site | Peoria | Illinois | 61637 | United States |
| Alkermes Investigator Site | Lansing | Michigan | 48911 | United States |
| Alkermes Investigator Site | Sterling Heights | Michigan | 48314 | United States |
| Alkermes Investigator Site | Lincoln | Nebraska | 68506 | United States |
| Alkermes Investigator Site | Middletown | New Jersey | 07748 | United States |
| Alkermes Investigator Site | Denver | North Carolina | 28037 | United States |
| Alkermes Investigator Site | Huntersville | North Carolina | 28078 | United States |
| Alkermes Investigator Site | Canton | Ohio | 44718 | United States |
| Alkermes Investigator Site | Cincinnati | Ohio | 45212 | United States |
| Alkermes Investigator Site | Cincinnati | Ohio | 45245 | United States |
| Alkermes Investigational Site | Cleveland | Ohio | 44195 | United States |
| Alkermes Investigator Site | Abington | Pennsylvania | 19001 | United States |
| Alkermes Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Alkermes Investigator Site | Wyomissing | Pennsylvania | 19610 | United States |
| Alkermes Investigator Site | Columbia | South Carolina | 29201 | United States |
| Alkermes Investigator Site | Cordova | Tennessee | 38108 | United States |
| Alkermes Investigator Site | Austin | Texas | 78731 | United States |
| Alkermes Investigator Site | San Antonio | Texas | 78229 | United States |
| Alkermes Investigational Site | Sugar Land | Texas | 77478 | United States |
| Alkermes Investigational Site | Madison | Wisconsin | 53792 | United States |
| Alkermes Investigator Site | Macquarie Park | New South Wales | 2113 | Australia |
| Alkermes Investigator Site | Bedford Park | South Australia | 5042 | Australia |
| Alkermes Investigational Site | Alken | 3570 | Belgium |
| Alkermes Investigational Site | Namur | 5101 | Belgium |
| Alkermes Investigational Site | Prague | 128 21 | Czechia |
| Alkermes Investigational Site | Bordeaux | 33076 | France |
| Alkermes Investigational Site | La Tronche | 38700 | France |
| Alkermes Investigational Site | Bologna | BO | 40139 | Italy |
| Alkermes Investigational Site | Milan | Metropolitan City Of Milan | 20132 | Italy |
| Alkermes Investigational site | Verona | 37134 | Italy |
| Alkermes Investigational Site | Zwolle | 8025BV | Netherlands |
| Alkermes Investigational Site | Barcelona | 08036 | Spain |
| Alkermes Investigational Site | Madrid | 28036 | Spain |
| Alkermes Investigational Site | Madrid | 28043 | Spain |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D012893 | Sleep Wake Disorders |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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