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A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
Sponsor: Alkermes, Inc.
Summary
The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.
Official title: A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 1
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2024-03-24
Completion Date
2025-07-31
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
ALKS 2680
Oral tablet of ALKS 2680 for once daily administration
Placebo
Oral tablet containing matching placebo for once daily administration
Locations (45)
Alkermes Investigational Site
Los Angeles, California, United States
Alkermes Investigational Site
Redwood City, California, United States
Alkermes Investigator Site
San Francisco, California, United States
Alkermes Investigational Site
Santa Ana, California, United States
Alkermes Investigational Site
Aurora, Colorado, United States
Alkermes Investigational Site
Colorado Springs, Colorado, United States
Alkermes Investigational Site
Brandon, Florida, United States
Alkermes Investigator Site
Brandon, Florida, United States
Alkermes Investigational Site
Miami, Florida, United States
Alkermes Investigator 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 Investigator Site
Peoria, Illinois, United States
Alkermes Investigator Site
Lansing, Michigan, United States
Alkermes Investigator Site
Sterling Heights, Michigan, United States
Alkermes Investigator 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 Investigator 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
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
The Woodlands, Texas, United States
Alkermes Investigator Site
Macquarie Park, New South Wales, Australia
Alkermes Investigator Site
Bedford Park, South Australia, Australia
Alkermes Investigational Site
Alken, Belgium
Alkermes Investigational Site
Bruges, Belgium
Alkermes Investigational Site
Namur, Belgium
Alkermes Investigational Site
Prague, Czechia
Alkermes Investigational Site
Bordeaux, France
Alkermes Investigational Site
Montpellier, France
Alkermes Investigational Site
Bologna, Italy
Alkermes Investigational Site
Milan, Italy
Alkermes Investigational Site
Verona, Italy
Alkermes Investigational Site
Heemstede, Netherlands
Alkermes Investigational Site
Zwolle, Netherlands
Alkermes Investigational Site
Barcelona, Spain
Alkermes Investigational Site
Madrid, Spain
Alkermes Investigational Site
Madrid, Spain