A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
Condition(s) studied
Investigational drug(s) / intervention(s)
ALKS 2680 Dose 1: Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
ALKS 2680 Dose 2: Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Placebo: Participants will receive placebo tablets, daily, orally for 12 weeks
Study summary
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.
Eligibility
Primary outcome measure(s)
- Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level — Baseline to Week 12
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Alkermes Investigational Site | Brandon | Florida | Recruiting |
| Alkermes Investigational Site | Miami | Florida | Recruiting |
| Alkermes Investigational Site | Winter Park | Florida | Recruiting |
| Alkermes Investigational Site | Atlanta | Georgia | Recruiting |
| Alkermes Investigational Site | Macon | Georgia | Recruiting |
| Alkermes Investigational Site | Lansing | Michigan | Recruiting |
| Alkermes Investigational Site | St Louis | Missouri | Recruiting |
| Alkermes Investigational Site | Charlotte | North Carolina | Recruiting |
| Alkermes Investigational Site | Cincinnati | Ohio | Recruiting |
| Alkermes Investigational Site | Colombia | South Carolina | Recruiting |
| Alkermes Investigational Site | Dallas | Texas | Recruiting |
| Alkermes Investigational Site | Frisco | Texas | Recruiting |
| Alkermes Investigational Site | San Antonio | Texas | Recruiting |
| Alkermes Investigational Site | Sugar Land | Texas | Recruiting |
| Alkermes Investigational Site | Spokane | Washington | Recruiting |
| Alkermes Investigational Site | Diest | Belgium | Recruiting |
| Alkermes Investigational Site | Markham | Ontario | Recruiting |
| Alkermes Investigational Site | Toronto | Ontario | Recruiting |
| Alkermes Investigational Site | Kumamoto | Japan | Recruiting |
| Alkermes Investigational Site | Krakow | Poland | Recruiting |
More Alkermes, Inc. trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07540897 on ClinicalTrials.gov ↗ ← All trials in Japan