A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)
Alkermes, Inc.
Summary
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
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 p…
Interventions
- DrugALKS 2680
Oral tablet containing ALKS 2680 for once daily administration
- DrugPlacebo
Oral placebo tablet for once daily administration
Locations (48)
- Alkermes Investigator SiteCullman, Alabama
- Alkermes Investigator SitePhoenix, Arizona
- Alkermes Investigator SiteLittle Rock, Arkansas
- Alkermes Investigator SiteLos Angeles, California
- Alkermes Investigator SiteRedwood City, California
- Alkermes Investigator SiteSan Francisco, California