A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Hypersomnia

In brief

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

Key facts

Study ID

NCT06843590

Run by

Alkermes, Inc.

People needed

126

Starts

2025-05-22

Expected to finish

2026-11-01

Last updated by the study team

2026-06-24

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: 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 Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years

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 subject safety, interfere with any study assessment, or affect the subject's ability to complete the study
• Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
• Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Where it is running

• Alkermes Investigator Site — Cullman, Alabama, United States (enrolling)
• Alkermes Investigator Site — Phoenix, Arizona, United States (enrolling)
• Alkermes Investigator Site — Little Rock, Arkansas, United States (enrolling)
• Alkermes Investigator Site — Los Angeles, California, United States (enrolling)
• Alkermes Investigator Site — Redwood City, California, United States (enrolling)
• Alkermes Investigator Site — San Francisco, California, United States (enrolling)
• Alkermes Investigational Site — Boulder, Colorado, United States (enrolling)
• Alkermes Investigator Site — Colorado Springs, Colorado, United States (enrolling)
• Alkermes Investigator Site — Brandon, Florida, United States (enrolling)
• Alkermes Investigator Site — Miami, Florida, United States (enrolling)
• Alkermes Investigator Site — Winter Park, Florida, United States (enrolling)
• Alkermes Investigator Site — Atlanta, Georgia, United States (enrolling)
• Alkermes Investigator Site — Macon, Georgia, United States (enrolling)
• Alkermes Investigator Site — Stockbridge, Georgia, United States (enrolling)
• Alkermes Investigator Site — Peoria, Illinois, United States (enrolling)
• Alkermes Investigator Site — Kansas City, Kansas, United States (enrolling)
• Alkermes Investigational Site — Boston, Massachusetts, United States (enrolling)
• Alkermes Investigator Site — Lansing, Michigan, United States (enrolling)
• Alkermes Investigator Site — Lincoln, Nebraska, United States (enrolling)
• Alkermes Investigator Site — Middletown, New Jersey, United States (enrolling)
• Alkermes Investigator Site — Denver, North Carolina, United States (enrolling)
• Alkermes Investigator Site — Huntersville, North Carolina, United States (enrolling)
• Alkermes Investigator Site — Canton, Ohio, United States (enrolling)
• Alkermes Investigator Site — Cincinnati, Ohio, United States (enrolling)
• Alkermes Investigator Site — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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