A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Narcolepsy Type 1

In brief

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.

Key facts

Study ID

NCT07455383

Run by

Alkermes, Inc.

People needed

150

Starts

2026-04-06

Expected to finish

2027-06-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT* or CSF hypocretin-1 level).

You may not qualify if…

• Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
• Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.
• Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment.
• Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Where it is running

• Alkermes Investigational Site — Cullman, Alabama, United States (enrolling)
• Alkermes Investigational Site — Phoenix, Arizona, United States (enrolling)
• Alkermes Investigational Site — Los Angeles, California, United States (enrolling)
• Alkermes Investigational Site — Boulder, Colorado, United States (enrolling)
• Alkermes Investigational Site — Brandon, Florida, United States (enrolling)
• Alkermes Investigational Site — Miami, Florida, United States (enrolling)
• Alkermes Investigational Site — Winter Park, Florida, United States (enrolling)
• Alkermes Investigational Site — Macon, Georgia, United States (enrolling)
• Alkermes Investigational Site — Kansas City, Kansas, United States (enrolling)
• Alkermes Investigational Site — Newton, Massachusetts, United States (enrolling)
• Alkermes Investigational Site — Lansing, Michigan, United States (enrolling)
• Alkermes Investigational Site — St Louis, Missouri, United States (enrolling)
• Alkermes Investigational Site — Middletown, New Jersey, United States (enrolling)
• Alkermes Investigational Site — Charlotte, North Carolina, United States (enrolling)
• Alkermes Investigational Site — Cincinnati, Ohio, United States (enrolling)
• Alkermes Investigational Site — Wyomissing, Pennsylvania, United States (enrolling)
• Alkermes Investigational Site — Columbia, South Carolina, United States (enrolling)
• Alkermes Investigational Site — Austin, Texas, United States (enrolling)
• Alkermes Investigational Site — San Antonio, Texas, United States (enrolling)
• Alkermes Investigational Site — Sugar Land, Texas, United States (enrolling)
• Alkermes Investigational Site — Macquarie Park, New South Wales, Australia (enrolling)
• Alkermes Investigational Site — Namur, Belgium (enrolling)
• Alkermes Investigational Site — Markham, Ontario, Canada (enrolling)
• Alkermes Investigational Site — Toronto, Ontario, Canada (enrolling)
• Alkermes Investigational Site — Bordeaux, France (enrolling)

Full record on ClinicalTrials.gov

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