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CompletedPhase 3

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

Key facts

Where
Atlanta, Austin, Boulder, Brandon, Charleston, Chevy Chase, Cincinnati, Clearwater, Colorado Springs, Columbia, Denver, Doral, Gastonia, Huntersville, Kalamazoo, Miami Lakes, Neptune City, Novi, Phoenix, San Antonio, Stockbridge, Winter Park, and Wyomissing, United StatesSee the 23 sites
Phase
Phase 3

Where in United States

  • 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
  • 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
  • Gastonia, North CarolinaHospital 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
  • Miami Lakes, FloridaHospital not named in the registryNo longer taking part
  • Neptune City, New JerseyHospital not named in the registryNo longer taking part
  • Novi, MichiganHospital not named in the registryNo longer taking part
  • Phoenix, ArizonaHospital not named in the registryNo longer taking part
  • San Antonio, TexasHospital not named in the registryNo longer taking part
  • Stockbridge, GeorgiaHospital 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
NCT05113745
Record updated
13 November 2025
Original description
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).Read full original descriptionShow less

A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy

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

Inclusion: Completed the treatment period of Study AXS-12-301; Willing and able to comply with the study requirements.

Exclusion: 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.

ClinicalTrials.gov NCT05113745