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)
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Alkermes Investigator Site
RECRUITING
Cullman
Arkansas
Alkermes Investigator Site
RECRUITING
Little Rock
Arizona
Alkermes Investigator Site
RECRUITING
Phoenix
California
Alkermes Investigator Site
RECRUITING
Los Angeles
Alkermes Investigator Site
RECRUITING
Redwood City
Alkermes Investigator Site
RECRUITING
San Francisco
Colorado
Alkermes Investigational Site
RECRUITING
Colorado Springs
Florida
Alkermes Investigational Site
RECRUITING
Brandon
Alkermes Investigator Site
RECRUITING
Brandon
Alkermes Investigator Site
RECRUITING
Miami
Alkermes Investigator Site
RECRUITING
Winter Park
Georgia
Alkermes Investigational Site
RECRUITING
Atlanta
Alkermes Investigator Site
RECRUITING
Macon
Alkermes Investigator Site
RECRUITING
Stockbridge
Illinois
Alkermes Investigator Site
RECRUITING
Peoria
Michigan
Alkermes Investigational Site
RECRUITING
Lansing
North Carolina
Alkermes Investigational Site
RECRUITING
Denver
Alkermes Investigational Site
RECRUITING
Huntersville
Nebraska
Alkermes Investigational Site
RECRUITING
Lincoln
New Jersey
Alkermes Investigator Site
RECRUITING
Middletown
Ohio
Alkermes Investigator Site
RECRUITING
Canton
Alkermes Investigational Site
RECRUITING
Cincinnati
Alkermes Investigator Site
RECRUITING
Cleveland
Pennsylvania
Alkermes Investigational Site
RECRUITING
Wyomissing
South Carolina
Alkermes Investigational Site
RECRUITING
Columbia
Texas
Alkermes Investigational Site
RECRUITING
Austin
Alkermes Investigational Site
RECRUITING
San Antonio
Alkermes Investigator Site
RECRUITING
Sugar Land
Alkermes Investigator Site
RECRUITING
Sugarland
Wisconsin
Alkermes Investigator Site
RECRUITING
Madison
Other Locations
Australia
Alkermes Investigator Site
RECRUITING
Bedford Park
Alkermes Investigator Site
RECRUITING
Sydney
Belgium
Alkermes Investigator Site
RECRUITING
Alken
Alkermes Investigator Site
RECRUITING
Namur
Italy
Alkermes Investigator Site
RECRUITING
Bologna
Alkermes Investigator Site
RECRUITING
Verona
Netherlands
Alkermes Investigator Site
RECRUITING
Zwolle
Spain
Alkermes Investigator Site
RECRUITING
Madrid
Alkermes Investigator Site
RECRUITING
Madrid
Contact Information
Primary
Director, Global Clinical Services
clinicaltrials@alkermes.com
888-235-8008 (US Only)
Backup
Director, Global Clinical Services
clinicaltrials@alkermes.com
571-599-2702 (Global)
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2026-06
Participants
Target number of participants: 96
Treatments
Experimental: ALKS 2680, 10 mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
Experimental: ALKS 2680, 14 mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
Experimental: ALKS 2680, 18 mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Placebo_comparator: Placebo
Oral placebo tablet for once daily administration
Related Therapeutic Areas
Sponsors
Leads: Alkermes, Inc.