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

Last updated: November 11, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Cataplexy

Narcolepsy

Treatment

AXS-12 (reboxetine)

Placebo

Clinical Study ID

NCT05113745
AXS-12-302
  • Ages 15-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completed the treatment period of Study AXS-12-301

  • Willing and able to comply with the study requirements

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: AXS-12 (reboxetine)
Phase: 3
Study Start date:
October 20, 2021
Estimated Completion Date:
November 15, 2024

Study Description

This study is a multi-center trial consisting of a 24-week open-label period, followed by a 4-week double-blind, placebo-controlled, randomized withdrawal period. At the Week 24 visit, subjects will be randomized in a 1:1 ratio either to continue to receive AXS-12 or to switch to placebo, for the next 4 weeks. Eligible subjects will have previously participated in the AXS-12-301 study.

Connect with a study center

  • Clinical Research Site

    Toronto, Ontario M5S 3A3
    Canada

    Site Not Available

  • Clinical Research Site

    Toronto 6167865, Ontario 6093943 M5S 3A3
    Canada

    Site Not Available

  • Clinical Research Site

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Clinical Research Site

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Site Not Available

  • Clinical Research Site

    Santa Ana, California 92705
    United States

    Site Not Available

  • Clinical Research Site

    Boulder, Colorado 80301
    United States

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  • Clinical Research Site

    Colorado Springs, Colorado 80918
    United States

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  • Clinical Research Site

    Boulder 5574991, Colorado 5417618 80301
    United States

    Site Not Available

  • Clinical Research Site

    Colorado Springs 5417598, Colorado 5417618 80918
    United States

    Site Not Available

  • Clinical Research Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Clinical Research Site

    Clearwater, Florida 33765
    United States

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  • Clinical Research Site

    Doral, Florida 33122
    United States

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  • Clinical Research Site

    Miami Lakes, Florida 33016
    United States

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  • Clinical Research Site

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Clinical Research Site

    Brandon 4148757, Florida 4155751 33511
    United States

    Site Not Available

  • Clinical Research Site

    Clearwater 4151316, Florida 4155751 33765
    United States

    Site Not Available

  • Clinical Research Site

    Doral 4153471, Florida 4155751 33122
    United States

    Site Not Available

  • Clinical Research Site

    Miami Lakes 4164186, Florida 4155751 33016
    United States

    Site Not Available

  • Clinical Research Site

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Clinical Research Site

    Atlanta, Georgia 30315
    United States

    Site Not Available

  • Clinical Research Site

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Clinical Research Site

    Atlanta 4180439, Georgia 4197000 30328
    United States

    Site Not Available

  • Clinical Research Site

    Stockbridge 4224681, Georgia 4197000 30281
    United States

    Site Not Available

  • Clinical Research Site

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Clinical Research Site

    Chevy Chase, Maryland 20815
    United States

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  • Clinical Research Site

    Chevy Chase 4351335, Maryland 4361885 20815
    United States

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  • Clinical Research Site

    Kalamazoo, Michigan 49008
    United States

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  • Clinical Research Site

    Novi, Michigan 48377
    United States

    Site Not Available

  • Clinical Research Site

    Kalamazoo 4997787, Michigan 5001836 49008
    United States

    Site Not Available

  • Clinical Research Site

    Novi 5004062, Michigan 5001836 48377
    United States

    Site Not Available

  • Clinical Research Site

    Saint Louis, Missouri 63123
    United States

    Site Not Available

  • Clinical Research Site

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Clinical Research Site

    Neptune City, New Jersey 07753
    United States

    Site Not Available

  • Clinical Research Site

    West Long Branch, New Jersey 07764
    United States

    Site Not Available

  • Clinical Research Site

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Site Not Available

  • Clinical Research Site

    Denver, North Carolina 28037
    United States

    Site Not Available

  • Clinical Research Site

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Clinical Research Site

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Clinical Research Site

    Denver 4463523, North Carolina 4482348 28037
    United States

    Site Not Available

  • Clinical Research Site

    Gastonia 4467732, North Carolina 4482348 28054
    United States

    Site Not Available

  • Clinical Research Site

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Site Not Available

  • Clinical Research Site

    Cincinnati, Ohio 45245
    United States

    Site Not Available

  • Clinical Research Site

    Cincinnati 4508722, Ohio 5165418 45245
    United States

    Site Not Available

  • Clinical Research Site

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Clinical Research Site

    Wyomissing 5220248, Pennsylvania 6254927 19610
    United States

    Site Not Available

  • Clinical Research Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Clinical Research Site

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Clinical Research Site

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Clinical Research Site

    Columbia 4575352, South Carolina 4597040 29201
    United States

    Site Not Available

  • Clinical Research Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Clinical Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Research Site

    Austin 4671654, Texas 4736286 78731
    United States

    Site Not Available

  • Clinical Research Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

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