Under construction – not a live service
Sign in
CompletedPhase 3

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

Key facts

Where
Alabaster, Atlanta, Austin, Boulder, Brandon, Brooklyn, Charleston, Chevy Chase, Cincinnati, Clearwater, Colorado Springs, Columbia, Denver, Doral, Fort Wayne, Gainesville, Gastonia, Honolulu, Huntersville, Kalamazoo, Kissimmee, Las Vegas, Macon, Miami, Miami Lakes, Neptune City, New Hyde Park, Newton, North Dartmouth, Novi, Peoria, Phoenix, Redwood City, San Antonio, San Diego, Santa Ana, Santa Monica, St Louis, St. Petersburg, Stockbridge, Sugar Land, Tampa, Williamsburg, Winter Park, and Wyomissing, United StatesSee the 45 sites
Phase
Phase 3

Where in United States

  • Alabaster, AlabamaHospital not named in the registryNo longer taking part
  • Atlanta, GeorgiaHospital not named in the registryNo longer taking part
  • Austin, TexasHospital not named in the registryNo longer taking part
  • Boulder, ColoradoHospital not named in the registryNo longer taking part
  • Brandon, FloridaHospital not named in the registryNo longer taking part
  • Brooklyn, New YorkHospital not named in the registryNo longer taking part
  • Charleston, South CarolinaHospital not named in the registryNo longer taking part
  • Chevy Chase, MarylandHospital not named in the registryNo longer taking part
  • Cincinnati, OhioHospital not named in the registryNo longer taking part
  • Clearwater, FloridaHospital not named in the registryNo longer taking part
  • Colorado Springs, ColoradoHospital not named in the registryNo longer taking part
  • Columbia, South CarolinaHospital not named in the registryNo longer taking part
  • Denver, North CarolinaHospital not named in the registryNo longer taking part
  • Doral, FloridaHospital not named in the registryNo longer taking part
  • Fort Wayne, IndianaHospital not named in the registryNo longer taking part
  • Gainesville, GeorgiaHospital not named in the registryNo longer taking part
  • Gastonia, North CarolinaHospital not named in the registryNo longer taking part
  • Honolulu, HawaiiHospital not named in the registryNo longer taking part
  • Huntersville, North CarolinaHospital not named in the registryNo longer taking part
  • Kalamazoo, MichiganHospital not named in the registryNo longer taking part
  • Kissimmee, FloridaHospital not named in the registryNo longer taking part
  • Las Vegas, NevadaHospital not named in the registryNo longer taking part
  • Macon, GeorgiaHospital not named in the registryNo longer taking part
  • Miami, FloridaHospital not named in the registryNo longer taking part
  • Miami Lakes, FloridaHospital not named in the registryNo longer taking part
  • Neptune City, New JerseyHospital not named in the registryNo longer taking part
  • New Hyde Park, New YorkHospital not named in the registryNo longer taking part
  • Newton, MassachusettsHospital not named in the registryNo longer taking part
  • North Dartmouth, MassachusettsHospital not named in the registryNo longer taking part
  • Novi, MichiganHospital not named in the registryNo longer taking part
  • Peoria, ArizonaHospital not named in the registryNo longer taking part
  • Phoenix, ArizonaHospital not named in the registryNo longer taking part
  • Redwood City, CaliforniaHospital not named in the registryNo longer taking part
  • San Antonio, TexasHospital not named in the registryNo longer taking part
  • San Diego, CaliforniaHospital not named in the registryNo longer taking part
  • Santa Ana, CaliforniaHospital not named in the registryNo longer taking part
  • Santa Monica, CaliforniaHospital not named in the registryNo longer taking part
  • St Louis, MissouriHospital not named in the registryNo longer taking part
  • St. Petersburg, FloridaHospital not named in the registryNo longer taking part
  • Stockbridge, GeorgiaHospital not named in the registryNo longer taking part
  • Sugar Land, TexasHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • Williamsburg, VirginiaHospital not named in the registryNo longer taking part
  • Winter Park, FloridaHospital not named in the registryNo longer taking part
  • Wyomissing, PennsylvaniaHospital not named in the registryNo longer taking part

Trial details

Who runs it
Axsome Therapeutics, Inc.
Trial code
NCT05059223
Record updated
28 May 2026
Original description
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).Read full original descriptionShow less

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

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).

Inclusion: 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.

Exclusion: Other clinically significant conditions potentially causing EDS; Clinically significant psychiatric disorders.

ClinicalTrials.gov NCT05059223