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The purpose of this study is to measure decreases in daytime sleepiness, and disease symptoms in participants with Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets compared with placebo tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 2680 Dose 1 | Experimental |
| |
| ALKS 2680 Dose 2 | Experimental |
| |
| ALKS 2680 Dose 3 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 2680 Dose 1 | Drug | Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level | Baseline to Week 12 | |
| Percentage of participants who achieve a status of "none" or "mild" on Patient Global Impression-Severity (PGI-S) scale (general disease) at Week 12 by dose level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Trial Manager | Contact | 888-235-8008 (US Only) | clinicaltrials@alkermes.com | |
| Director Clinical Trial Manager | Contact | 571-599-2702 (Global) | clinicaltrials@alkermes.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Recruiting | Cullman | Alabama | 35055 | United States | |
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| Label | URL |
|---|---|
| Brilliance NT2 Studies | View source |
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| ALKS 2680 Dose 2 | Drug | Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks |
|
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| ALKS 2680 Dose 3 | Drug | Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks |
|
|
| Placebo | Drug | Participants will receive placebo tablets, daily, orally for 12 weeks |
|
| Week 12 |
| Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level | Baseline to Week 12 |
| Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level | Baseline to Week 12 |
| Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baseline to Week 12 by dose level | Baseline to Week 12 |
| Percentage of participants who achieve a status of "normal, not ill at all", "borderline ill", or "mildly ill" on Clinical Global Impression-Severity (CGI-S) (general disease) at Week 12 by dose level | Week 12 |
| Incidence of treatment emergent adverse events | Up to 14 weeks |
| Alkermes Investigational Site |
| Recruiting |
| Los Angeles |
| California |
| 90025 |
| United States |
| Alkermes Investigational Site | Recruiting | Boulder | Colorado | 80301 | United States |
| Alkermes Investigational Site | Recruiting | Brandon | Florida | 33511 | United States |
| Alkermes Investigational Site | Recruiting | Maimi | Florida | 33176 | United States |
| Alkermes Investigational Site | Recruiting | Winter Park | Florida | 32789 | United States |
| Alkermes Investigational Site | Recruiting | Macon | Georgia | 31210 | United States |
| Alkermes Investigational Site | Recruiting | Kansas City | Kansas | 66160 | United States |
| Alkermes Investigational Site | Recruiting | Newton | Massachusetts | 02459 | United States |
| Alkermes Investigational Site | Not yet recruiting | Lansing | Michigan | 48911 | United States |
| Alkermes Investigational Site | Recruiting | Huntersville | North Carolina | 28078 | United States |
| Alkermes Investigational Site | Recruiting | Cincinnati | Ohio | 45245 | 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 | Markham | Ontario | L3R 1A3 | Canada |
| Alkermes Investigational Site | Recruiting | Toronto | Ontario | M5S 3A3 | Canada |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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