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The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 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 |
| |
| 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 | |
| Weekly cataplexy rate (WCR) at Week 12 by dose level | Week 12 | |
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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 |
|---|---|---|
| Medical Director, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Recruiting | Miami | Florida | 33176 | United States | |
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| Label | URL |
|---|---|
| Brilliance NT1 Studies | View source |
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| ALKS 2680 Dose 2 | Drug | Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks |
|
|
| Placebo | Drug | Participants will receive placebo tablets, daily, orally for 12 weeks |
|
| 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 |
| 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 baselineto 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 |
| Change in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) from baseline to Week 12 by dose level | Baseline to Week 12 |
| Incidence of treatment emergent adverse events | Baseline to Week 14 |
| 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 | Lansing | Michigan | 48911 | United States |
| Alkermes Investigational Site | Recruiting | St Louis | Missouri | 63123 | United States |
| Alkermes Investigational Site | Recruiting | Cincinnati | Ohio | 45245 | United States |
| Alkermes Investigational Site | Recruiting | Dallas | Texas | 75251 | United States |
| Alkermes Investigational Site | Recruiting | San Antonio | Texas | 78229 | United States |
| Alkermes Investigational Site | Recruiting | Sugar Land | Texas | 77478 | United States |
| ID | Term |
|---|---|
| D000077260 | Sleepiness |
| D012893 | Sleep Wake Disorders |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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