A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Idiopathic Hypersomnia
Age
18 - 70
Phase
PHASE2
Participants Needed
96
Est. Completion Date
Jun 30, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Alkermes, Inc.
ClinicalTrials.gov NCT Identifier
NCT06843590
Study Number
ALKS 2680-203
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