A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

Completed · Phase 3 · Has a placebo group

Conditions studied: Narcolepsy, Cataplexy, Excessive Daytime Sleepiness

In brief

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).

Key facts

Study ID

NCT05059223

Run by

Axsome Therapeutics, Inc.

People needed

90

Starts

2021-09-15

Expected to finish

2024-03-15

Last updated by the study team

2026-05-28

Who can join

Age: 15 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects between 15 and 75 years of age, inclusive
• Primary diagnosis of narcolepsy with cataplexy
• Willing and able to comply with the study requirements

You may not qualify if…

• Other clinically significant conditions potentially causing EDS
• Clinically significant psychiatric disorders

Where it is running

• Clinical Research Site — Alabaster, Alabama, United States
• Clinical Research Site — Peoria, Arizona, United States
• Clinical Research Site — Phoenix, Arizona, United States
• Clinical Research Site — Redwood City, California, United States
• Clinical Research Site — San Diego, California, United States
• Clinical Research Site — Santa Ana, California, United States
• Clinical Research Site — Santa Monica, California, United States
• Clinical Research Site — Boulder, Colorado, United States
• Clinical Research Site — Colorado Springs, Colorado, United States
• Clinical Research Site — Brandon, Florida, United States
• Clinical Research Site — Clearwater, Florida, United States
• Clinical Research Site — Doral, Florida, United States
• Clinical Research Site — Kissimmee, Florida, United States
• Clinical Research Site — Miami, Florida, United States
• Clinical Research Site — Miami Lakes, Florida, United States
• Clinical Research Site — St. Petersburg, Florida, United States
• Clinical Research Site — Tampa, Florida, United States
• Clinical Research Site — Winter Park, Florida, United States
• Clinical Research Site — Atlanta, Georgia, United States
• Clinical Research Site — Atlanta, Georgia, United States
• Clinical Research Site — Gainesville, Georgia, United States
• Clinical Research Site — Macon, Georgia, United States
• Clinical Research Site — Stockbridge, Georgia, United States
• Clinical Research Site — Honolulu, Hawaii, United States
• Clinical Research Site — Peoria, Illinois, United States

Full record on ClinicalTrials.gov

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