A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
Condition(s) studied
Investigational drug(s) / intervention(s)
ALKS 2680 Dose 1: Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
ALKS 2680 Dose 2: Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
Placebo: Participants will receive ALKS 2680-matching placebo tablets, 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 (44)
| Facility | City | Region | Status |
|---|---|---|---|
| Alkermes Investigational Site | Cullman | Alabama | Recruiting |
| Alkermes Investigational Site | Phoenix | Arizona | Recruiting |
| Alkermes Investigational Site | Los Angeles | California | Recruiting |
| Alkermes Investigational Site | Boulder | Colorado | Recruiting |
| Alkermes Investigational Site | Brandon | Florida | Recruiting |
| Alkermes Investigational Site | Miami | Florida | Recruiting |
| Alkermes Investigational Site | Winter Park | Florida | Recruiting |
| Alkermes Investigational Site | Macon | Georgia | Recruiting |
| Alkermes Investigational Site | Kansas City | Kansas | Recruiting |
| Alkermes Investigational Site | Newton | Massachusetts | Recruiting |
| Alkermes Investigational Site | Lansing | Michigan | Recruiting |
| Alkermes Investigational Site | Novi | Michigan | Recruiting |
| Alkermes Investigational Site | St Louis | Missouri | Recruiting |
| Alkermes Investigational Site | Middletown | New Jersey | Recruiting |
| Alkermes Investigational Site | Charlotte | North Carolina | Recruiting |
| Alkermes Investigational Site | Cincinnati | Ohio | Recruiting |
| Alkermes Investigational Site | Wyomissing | Pennsylvania | Recruiting |
| Alkermes Investigational Site | Columbia | South Carolina | Recruiting |
| Alkermes Investigational Site | Austin | Texas | Recruiting |
| Alkermes Investigational Site | San Antonio | Texas | Recruiting |
| Alkermes Investigational Site | Sugar Land | Texas | Recruiting |
| Alkermes Investigational Site | Madison | Wisconsin | Recruiting |
| Alkermes Investigational Site | Macquarie Park | New South Wales | Recruiting |
| Alkermes Investigational Site | Bruges | Belgium | Recruiting |
| Alkermes Investigational Site | Edegem | Belgium | Recruiting |
| Alkermes Investigational Site | Ghent | Belgium | Recruiting |
| Alkermes Investigational Site | Namur | Belgium | Recruiting |
| Alkermes Investigational Site | Markham | Ontario | Recruiting |
| Alkermes Investigational Site | Toronto | Ontario | Recruiting |
| Alkermes Investigational Site | Bordeaux | France | Recruiting |
| Alkermes Investigational Site | Lyon | France | Recruiting |
| Alkermes Investigational Site | Montpellier | France | Recruiting |
| Alkermes Investigational Site | Verona | Italy | Recruiting |
| Alkermes Investigational Site | Kitakyushu-shi | Fukuoka | Recruiting |
| Alkermes Investigational Site | Osaka | Osaka | Recruiting |
| Alkermes Investigational Site | Shibuya-ku | Tokyo-To | Recruiting |
| Alkermes Investigational Site | Shinjuku-Ku | Tokyo-To | Recruiting |
| Alkermes Investigational Site | Kumamoto | Japan | Recruiting |
| Alkermes Investigational Site | Zwolle | Overijssel | Recruiting |
| Alkermes Investigational Site | Heeze | Netherlands | Recruiting |
+ 4 more sites — see the full list on the official registry below.
More Alkermes, Inc. trials in the USA
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 NCT07455383 on ClinicalTrials.gov ↗ ← All trials in the USA