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The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narcolepsy Type 1 (NT1) | Experimental |
| |
| Narcolepsy Type 2 (NT2) | Experimental |
| |
| Idiopathic Hypersomnia (IH) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 2680, 4mg | Drug | Oral tablet containing 4 mg of ALKS 2680 for once daily administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Up to 100 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) | Baseline to Week 24 | |
| Change in Epworth Sleepiness Scale (ESS) | Baseline to 96 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 | Phoenix | Arizona | 85054 | United States | |
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| ALKS 2680, 6mg | Drug | Oral tablet containing 6 mg of ALKS 2680 for once daily administration |
|
| ALKS 2680, 8mg | Drug | Oral tablet containing 8 mg of ALKS 2680 for once daily administration |
|
| ALKS 2680, 10mg | Drug | Oral tablet containing 10 mg of ALKS 2680 for once daily administration |
|
| ALKS 2680, 14mg | Drug | Oral tablet containing 14 mg of ALKS 2680 for once daily administration |
|
| ALKS 2680, 18mg | Drug | Oral tablet containing 18 mg of ALKS 2680 for once daily administration |
|
| Alkermes Investigational Site |
| Recruiting |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Alkermes Investigational Site | Recruiting | Los Angeles | California | 90025 | United States |
| Alkermes Investigator Site | Recruiting | San Francisco | California | 94158 | United States |
| Alkermes Investigational Site | Recruiting | Stanford | California | 94305 | United States |
| Alkermes Investigational Site | Recruiting | Colorado Springs | Colorado | 80918 | United States |
| Alkermes Investigational Site | Recruiting | Brandon | Florida | 33511 | United States |
| Alkermes Investigational Site | Recruiting | Miami | Florida | 33176 | United States |
| Alkermes Investigational Site | Recruiting | Winter Park | Florida | 32789 | United States |
| Alkermes Investigational Site | Recruiting | Atlanta | Georgia | 30328 | United States |
| Alkermes Investigational Site | Recruiting | Macon | Georgia | 31210 | United States |
| Alkermes Investigational Site | Recruiting | Stockbridge | Georgia | 30281 | United States |
| Alkermes Investigational Site | Recruiting | Peoria | Illinois | 61637 | United States |
| Alkermes Investigational Site | Recruiting | Lansing | Michigan | 48911 | United States |
| Alkermes Investigational Site | Recruiting | Sterling Heights | Michigan | 48314 | United States |
| Alkermes Investigational Site | Recruiting | Lincoln | Nebraska | 68506 | United States |
| Alkermes Investigational Site | Recruiting | Middletown | New Jersey | 07748 | United States |
| Alkermes Investigational Site | Recruiting | Denver | North Carolina | 28037 | United States |
| Alkermes Investigational Site | Recruiting | Huntersville | North Carolina | 28708 | United States |
| Alkermes Investigational Site | Recruiting | Canton | Ohio | 44718 | United States |
| Alkermes Investigational Site | Recruiting | Cincinnati | Ohio | 45212 | United States |
| Alkermes Investigational Site | Recruiting | Cincinnati | Ohio | 45245 | United States |
| Alkermes Investigational Site | Recruiting | Dublin | Ohio | 43017 | United States |
| Alkermes Investigational Site | Recruiting | Abington | Pennsylvania | 19001 | United States |
| Alkermes Investigational Site | Recruiting | Wyomissing | Pennsylvania | 19610 | United States |
| Alkermes Investigational Site | Recruiting | Columbia | South Carolina | 29201 | United States |
| Alkermes Investigational Site | Recruiting | Austin | Texas | 78731 | United States |
| Alkermes Investigational Site | Recruiting | San Antonio | Texas | 78229 | United States |
| Alkermes Investigational Site | Recruiting | Sugar Land | Texas | 77478 | United States |
| Alkermes Investigational Site | Recruiting | Madison | Wisconsin | 53706 | United States |
| Alkermes Investigational Site | Recruiting | Sydney | New South Wales | 2113 | Australia |
| Alkermes Investigational Site | Recruiting | Bedford Park | South Australia | 5042 | Australia |
| Alkermes Investigational Site | Recruiting | Clayton | Victoria | 3168 | Australia |
| Alkermes Investigational Site | Recruiting | Bruges | Brugge | 8000 | Belgium |
| Alkermes Investigational Site | Recruiting | Alken | 3570 | Belgium |
| Alkermes Investigational Site | Recruiting | Namur | 5101 | Belgium |
| Alkermes Investigational Site | Recruiting | Prague | 128 21 | Czechia |
| Alkermes Investigational Site | Recruiting | Montpellier | Herault | 34295 | France |
| Alkermes Investigational Site | Recruiting | Bordeaux | 33000 | France |
| Alkermes Investigational Site | Recruiting | Bologna | 40139 | Italy |
| Alkermes Investigational Site | Recruiting | Milan | 20127 | Italy |
| Alkermes Investigational Site | Recruiting | Verona | 37134 | Italy |
| Alkermes Investigational Site | Recruiting | Zwolle | 8025 | Netherlands |
| Alkermes Investigational Site | Recruiting | Madrid | Madrid | 28036 | Spain |
| Alkermes Investigational Site | Recruiting | Barcelona | 08036 | Spain |
| Alkermes Investigational Site | Recruiting | Madrid | 28043 | Spain |
| ID | Term |
|---|---|
| D020177 | Idiopathic Hypersomnia |
| 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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