A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)

Completed · Phase 3 · Has a placebo group

Conditions studied: Narcolepsy, Cataplexy, Excessive Daytime Sleepiness

In brief

This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Key facts

Study ID

NCT05113745

Run by

Axsome Therapeutics, Inc.

People needed

68

Starts

2021-10-20

Expected to finish

2024-11-15

Last updated by the study team

2025-11-13

Who can join

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

You may qualify if…

• Completed the treatment period of Study AXS-12-301
• Willing and able to comply with the study requirements

You may not qualify if…

• Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12

Where it is running

• Clinical Research Site — Phoenix, Arizona, 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 — Miami Lakes, 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 — Stockbridge, Georgia, United States
• Clinical Research Site — Chevy Chase, Maryland, United States
• Clinical Research Site — Kalamazoo, Michigan, United States
• Clinical Research Site — Novi, Michigan, United States
• Clinical Research Site — Neptune City, New Jersey, United States
• Clinical Research Site — Denver, North Carolina, United States
• Clinical Research Site — Gastonia, North Carolina, United States
• Clinical Research Site — Huntersville, North Carolina, United States
• Clinical Research Site — Cincinnati, Ohio, United States
• Clinical Research Site — Wyomissing, Pennsylvania, United States
• Clinical Research Site — Charleston, South Carolina, United States
• Clinical Research Site — Columbia, South Carolina, United States
• Clinical Research Site — Austin, Texas, United States
• Clinical Research Site — San Antonio, Texas, United States
• Clinical Research Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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