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The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg ALKS 2680 | Experimental |
| |
| 6 mg ALKS 2680 | Experimental |
| |
| 8 mg ALKS 2680 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 2680 | Drug | Oral tablet of ALKS 2680 for once daily administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6 | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6 | Epsworth Sleepiness Scale is a 4-point scale used to measure excessive sleepiness from 0 (would never doze) to 3 (high chance of "dozing) | Baseline to Week 6 |
| Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary |
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Inclusion Criteria:
18-70 years of age
Has a BMI ≥18 and ≤40 kg/m2
Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:
Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
Is willing to adhere to additional protocol requirements
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Medical Director, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Los Angeles | California | 90025 | United States | ||
| Alkermes Investigational Site |
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| Label | URL |
|---|---|
| Vibrance-1 Study | View source |
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| Placebo | Drug | Oral tablet containing matching placebo for once daily administration |
|
| Measured at Week 5 and 6 |
| Incidence of adverse events | Up to 15 Weeks |
| Redwood City |
| California |
| 94063 |
| United States |
| Alkermes Investigator Site | San Francisco | California | 94107 | United States |
| Alkermes Investigational Site | Santa Ana | California | 92705 | United States |
| Alkermes Investigational Site | Aurora | Colorado | 80045 | United States |
| Alkermes Investigational Site | Colorado Springs | Colorado | 80918 | United States |
| Alkermes Investigational Site | Brandon | Florida | 33511 | United States |
| Alkermes Investigator Site | Brandon | Florida | 33511 | United States |
| Alkermes Investigational Site | Miami | Florida | 33176 | United States |
| Alkermes Investigator Site | Winter Park | Florida | 32789 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30328 | United States |
| Alkermes Investigational Site | Macon | Georgia | 31210 | United States |
| Alkermes Investigational Site | Stockbridge | Georgia | 30281 | United States |
| Alkermes Investigator 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 Investigational Site | Middletown | New Jersey | 07748 | United States |
| Alkermes Investigational Site | Denver | North Carolina | 28037 | United States |
| Alkermes Investigational Site | Huntersville | North Carolina | 28708 | United States |
| Alkermes Investigator Site | Canton | Ohio | 44718 | United States |
| Alkermes Investigational Site | Cincinnati | Ohio | 45227 | United States |
| Alkermes Investigational Site | Cincinnati | Ohio | 45245 | United States |
| Alkermes Investigational Site | Dublin | Ohio | 43017 | United States |
| Alkermes Investigational Site | Wyomissing | Pennsylvania | 19610 | United States |
| Alkermes Investigational Site | Columbia | South Carolina | 29201 | United States |
| Alkermes Investigational Site | Austin | Texas | 78731 | United States |
| Alkermes Investigational Site | San Antonio | Texas | 78229 | United States |
| Alkermes Investigational Site | The Woodlands | Texas | 77380 | 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 | Bruges | 8000 | Belgium |
| Alkermes Investigational Site | Namur | 5101 | Belgium |
| Alkermes Investigational Site | Prague | 128 21 | Czechia |
| Alkermes Investigational Site | Bordeaux | 33000 | France |
| Alkermes Investigational Site | Montpellier | 34295 | France |
| Alkermes Investigational Site | Bologna | 40139 | Italy |
| Alkermes Investigational Site | Milan | 20127 | Italy |
| Alkermes Investigational Site | Verona | 37134 | Italy |
| Alkermes Investigational Site | Heemstede | 2103 SW | Netherlands |
| Alkermes Investigational Site | Zwolle | 8025 BV | Netherlands |
| Alkermes Investigational Site | Barcelona | 08036 | Spain |
| Alkermes Investigational Site | Madrid | 28036 | Spain |
| Alkermes Investigational Site | Madrid | 28043 | Spain |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D002385 | Cataplexy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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