A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Narcolepsy Type 2

In brief

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.

Key facts

Study ID

NCT07502443

Run by

Alkermes, Inc.

People needed

176

Starts

2026-04-22

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…

• Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
• Meets the diagnostic criteria of NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT).

You may not qualify if…

• Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
• Has a history or presence 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 2680-202 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 — Barcelona, Spain (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 — Maimi, Florida, United States (enrolling)
• Alkermes Investigational Site — Winter Park, Florida, United States (enrolling)
• Alkermes Investigational Site — Macon, Georgia, United States (enrolling)
• Alkermes Investigational Site — Stockbridge, Georgia, United States (enrolling)
• Alkermes Investigational Site — Kansas City, Kansas, United States (enrolling)
• Alkermes Investigational Site — Newton, Massachusetts, United States (enrolling)
• Alkermes Investigational Site — Cullman, Alabama, United States (enrolling)
• Alkermes Investigational Site — Charlotte, North Carolina, United States (enrolling)
• Alkermes Investigational Site — Huntersville, 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 — Namur, Belgium (enrolling)
• Alkermes Investigational Site — Markham, Ontario, Canada (enrolling)
• Alkermes Investigational Site — Toronto, Ontario, Canada (enrolling)
• Alkermes Investigational Site — Bordeaux, France (enrolling)
• Alkermes Investigational Site — Lyon, France (enrolling)
• Alkermes Investigational Site — Montpellier, France (enrolling)

Full record on ClinicalTrials.gov

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