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The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 2680, 10 mg- Part A | Experimental | Oral tablet containing 10 mg of ALKS 2680 for once daily administration |
|
| ALKS 2680, 14 mg -Part A | Experimental | Oral tablet containing 14 mg of ALKS 2680 for once daily administration |
|
| ALKS 2680, 18 mg- Part A | Experimental | Oral tablet containing 18 mg of ALKS 2680 for once daily administration |
|
| Placebo- Part A | Placebo Comparator | Oral placebo tablet for once daily administration |
|
| ALKS 2680 Dose 1- Part B | Experimental | Oral tablets of ALKS 2680 taken, orally, daily |
|
| Placebo - Part B | Placebo Comparator | Oral tablets of placebo taken, orally, daily |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 2680 | Drug | Oral tablet containing ALKS 2680 for daily, oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level | Up to 8 weeks | |
| Incidence of treatment emergent adverse events | Up to 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director, Global Clinical Services | Contact | 888-235-8008 (US Only) | clinicaltrials@alkermes.com | |
| Director, Global Clinical Services | Contact | 571-599-2702 (Global) | clinicaltrials@alkermes.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigator Site | Recruiting | Cullman | Alabama | 35055 | United States | |
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| Label | URL |
|---|---|
| Vibrance Study for IH | View source |
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|
| Placebo | Drug | Oral placebo tablet for daily administration |
|
| Alkermes Investigator Site |
| Recruiting |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Alkermes Investigator Site | Recruiting | Little Rock | Arkansas | 72211 | United States |
| Alkermes Investigator Site | Recruiting | Los Angeles | California | 90025 | United States |
| Alkermes Investigator Site | Recruiting | Redwood City | California | 94063 | United States |
| Alkermes Investigator Site | Recruiting | San Francisco | California | 94143 | United States |
| Alkermes Investigational Site | Recruiting | Boulder | Colorado | 80301 | United States |
| Alkermes Investigator Site | Recruiting | Colorado Springs | Colorado | 80918 | United States |
| Alkermes Investigator Site | Recruiting | Brandon | Florida | 33511 | United States |
| Alkermes Investigator Site | Recruiting | Miami | Florida | 33176 | United States |
| Alkermes Investigator Site | Recruiting | Winter Park | Florida | 32789 | United States |
| Alkermes Investigator Site | Recruiting | Atlanta | Georgia | 30328 | United States |
| Alkermes Investigator Site | Recruiting | Macon | Georgia | 31210 | United States |
| Alkermes Investigator Site | Recruiting | Stockbridge | Georgia | 30281 | United States |
| Alkermes Investigator Site | Recruiting | Peoria | Illinois | 61637 | United States |
| Alkermes Investigator Site | Recruiting | Kansas City | Kansas | 66160 | United States |
| Alkermes Investigational Site | Recruiting | Boston | Massachusetts | 02215 | United States |
| Alkermes Investigator Site | Recruiting | Lansing | Michigan | 48911 | United States |
| Alkermes Investigator Site | Recruiting | Lincoln | Nebraska | 68506 | United States |
| Alkermes Investigator Site | Recruiting | Middletown | New Jersey | 07748 | United States |
| Alkermes Investigator Site | Recruiting | Denver | North Carolina | 28037 | United States |
| Alkermes Investigator Site | Recruiting | Huntersville | North Carolina | 28078 | United States |
| Alkermes Investigator Site | Recruiting | Canton | Ohio | 44718 | United States |
| Alkermes Investigator Site | Recruiting | Cincinnati | Ohio | 45245 | United States |
| Alkermes Investigator Site | Recruiting | Cleveland | Ohio | 44195 | United States |
| Alkermes Investigator Site | Recruiting | Danville | Pennsylvania | 17822 | United States |
| Alkermes Investigator Site | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Alkermes Investigator Site | Recruiting | Wyomissing | Pennsylvania | 19610 | United States |
| Alkermes Investigator Site | Recruiting | Columbia | South Carolina | 29201 | United States |
| Alkermes Investigator Site | Recruiting | Austin | Texas | 78731 | United States |
| Alkermes Investigator Site | Recruiting | San Antonio | Texas | 78229 | United States |
| Alkermes Investigator Site | Recruiting | Sugar Land | Texas | 77478 | United States |
| Alkermes Investigator Site | Recruiting | Sugarland | Texas | 77478 | United States |
| Alkermes Investigator Site | Recruiting | Madison | Wisconsin | 53792 | United States |
| Alkermes Investigator Site | Recruiting | Sydney | New South Wales | 2113 | Australia |
| Alkermes Investigator Site | Recruiting | Bedford Park | South Australia | 5042 | Australia |
| Alkermes Investigator Site | Recruiting | Clayton | Victoria | 3168 | Australia |
| Alkermes Investigator Site | Recruiting | Alken | 3570 | Belgium |
| Alkermes Investigator Site | Recruiting | Namur | 5101 | Belgium |
| Alkermes Investigator Site | Recruiting | Prague | 128 21 | Czechia |
| Alkermes Investigator Site | Recruiting | Bordeaux | Gironde | 33000 | France |
| Alkermes Investigator Site | Recruiting | Montpellier | Herault | 34295 | France |
| Alkermes Investigator Site | Recruiting | Grenoble | Isere | 38043 | France |
| Alkermes Investigator Site | Recruiting | Bologna | 40139 | Italy |
| Alkermes Investigator Site | Recruiting | Milan | 20127 | Italy |
| Alkermes Investigator Site | Recruiting | Verona | 37134 | Italy |
| Alkermes Investigator Site | Recruiting | Zwolle | 8025 BV | Netherlands |
| Alkermes Investigator Site | Recruiting | Barcelona | 8036 | Spain |
| Alkermes Investigator Site | Recruiting | Madrid | 28036 | Spain |
| Alkermes Investigator Site | Recruiting | Madrid | 28043 | Spain |
| ID | Term |
|---|---|
| D020177 | Idiopathic Hypersomnia |
| 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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