Clinical Research Directory
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A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
Sponsor: Axsome Therapeutics, Inc.
Summary
This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
Key Details
Gender
All
Age Range
15 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2021-09-15
Completion Date
2024-03-15
Last Updated
2026-05-28
Healthy Volunteers
No
Interventions
AXS-12 (reboxetine)
AXS-12 tablets, taken twice daily
Placebo
Placebo tablets, taken twice daily
Locations (50)
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Alabaster, Alabama, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Redwood City, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Santa Monica, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Brandon, Florida, United States
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Clearwater, Florida, United States
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Doral, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Gainesville, Georgia, United States
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Macon, Georgia, United States
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Stockbridge, Georgia, United States
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Honolulu, Hawaii, United States
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Peoria, Illinois, United States
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Fort Wayne, Indiana, United States
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Chevy Chase, Maryland, United States
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Newton, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Novi, Michigan, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Neptune City, New Jersey, United States
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Brooklyn, New York, United States
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New Hyde Park, New York, United States
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Denver, North Carolina, United States
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Gastonia, North Carolina, United States
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Huntersville, North Carolina, United States
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Cincinnati, Ohio, United States
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Wyomissing, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Austin, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Williamsburg, Virginia, United States
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Markham, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada