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A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Sponsor: Alkermes, Inc.
Summary
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
Official title: An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
256
Start Date
2025-01-27
Completion Date
2028-06
Last Updated
2026-03-04
Healthy Volunteers
No
Interventions
ALKS 2680, 4mg
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
ALKS 2680, 6mg
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
ALKS 2680, 8mg
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
ALKS 2680, 10mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
ALKS 2680, 14mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
ALKS 2680, 18mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Locations (46)
Alkermes Investigator Site
Phoenix, Arizona, United States
Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Los Angeles, California, United States
Alkermes Investigator Site
San Francisco, California, United States
Alkermes Investigational Site
Stanford, California, United States
Alkermes Investigational Site
Colorado Springs, Colorado, United States
Alkermes Investigational Site
Brandon, Florida, United States
Alkermes Investigational Site
Miami, Florida, United States
Alkermes Investigational Site
Winter Park, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Macon, Georgia, United States
Alkermes Investigational Site
Stockbridge, Georgia, United States
Alkermes Investigational Site
Peoria, Illinois, United States
Alkermes Investigational Site
Lansing, Michigan, United States
Alkermes Investigational Site
Sterling Heights, Michigan, United States
Alkermes Investigational Site
Lincoln, Nebraska, United States
Alkermes Investigational Site
Middletown, New Jersey, United States
Alkermes Investigational Site
Denver, North Carolina, United States
Alkermes Investigational Site
Huntersville, North Carolina, United States
Alkermes Investigational Site
Canton, Ohio, United States
Alkermes Investigational Site
Cincinnati, Ohio, United States
Alkermes Investigational Site
Cincinnati, Ohio, United States
Alkermes Investigational Site
Dublin, Ohio, United States
Alkermes Investigational Site
Abington, Pennsylvania, United States
Alkermes Investigational Site
Wyomissing, Pennsylvania, United States
Alkermes Investigational Site
Columbia, South Carolina, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
San Antonio, Texas, United States
Alkermes Investigational Site
Sugar Land, Texas, United States
Alkermes Investigational Site
Madison, Wisconsin, United States
Alkermes Investigational Site
Sydney, New South Wales, Australia
Alkermes Investigational Site
Bedford Park, South Australia, Australia
Alkermes Investigational Site
Clayton, Victoria, Australia
Alkermes Investigational Site
Bruges, Brugge, Belgium
Alkermes Investigational Site
Alken, Belgium
Alkermes Investigational Site
Namur, Belgium
Alkermes Investigational Site
Prague, Czechia
Alkermes Investigational Site
Montpellier, Herault, France
Alkermes Investigational Site
Bordeaux, France
Alkermes Investigational Site
Bologna, Italy
Alkermes Investigational Site
Milan, Italy
Alkermes Investigational Site
Verona, Italy
Alkermes Investigational Site
Zwolle, Netherlands
Alkermes Investigational Site
Madrid, Madrid, Spain
Alkermes Investigational Site
Barcelona, Spain
Alkermes Investigational Site
Madrid, Spain