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

May 26, 2026 updated by: Axsome Therapeutics, Inc.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible subjects must have a diagnosis of narcolepsy per the International Classification of Sleep Disorders (ICSD-3), and exhibit symptoms of both cataplexy and EDS. Subjects meeting the entry criteria will be randomized in a 1:1 ratio to receive either AXS-12 or placebo for five weeks.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Markham, Ontario, Canada, L3R 1A3
        • Clinical Research Site
      • Toronto, Ontario, Canada, M5S 3A3
        • Clinical Research Site
      • Toronto, Ontario, Canada, M4P 1P2
        • Clinical Research Site
  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • Clinical Research Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Clinical Research Site
      • Phoenix, Arizona, United States, 85054
        • Clinical Research Site
    • California
      • Redwood City, California, United States, 94063
        • Clinical Research Site
      • San Diego, California, United States, 92103
        • Clinical Research Site
      • Santa Ana, California, United States, 92705
        • Clinical Research Site
      • Santa Monica, California, United States, 90404
        • Clinical Research Site
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Clinical Research Site
      • Colorado Springs, Colorado, United States, 80918
        • Clinical Research Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Clinical Research Site
      • Clearwater, Florida, United States, 33765
        • Clinical Research Site
      • Doral, Florida, United States, 33122
        • Clinical Research Site
      • Kissimmee, Florida, United States, 34741
        • Clinical Research Site
      • Miami, Florida, United States, 33176
        • Clinical Research Site
      • Miami Lakes, Florida, United States, 33016
        • Clinical Research Site
      • St. Petersburg, Florida, United States, 33707
        • Clinical Research Site
      • Tampa, Florida, United States, 33634
        • Clinical Research Site
      • Winter Park, Florida, United States, 32789
        • Clinical Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Clinical Research Site
      • Atlanta, Georgia, United States, 30315
        • Clinical Research Site
      • Gainesville, Georgia, United States, 30501
        • Clinical Research Site
      • Macon, Georgia, United States, 31210
        • Clinical Research Site
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Clinical Research Site
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Clinical Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Clinical Research Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Clinical Research Site
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • Clinical Research Site
      • North Dartmouth, Massachusetts, United States, 02747
        • Clinical Research Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • Clinical Research Site
      • Novi, Michigan, United States, 48377
        • Clinical Research Site
    • Missouri
      • St Louis, Missouri, United States, 63123
        • Clinical Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Clinical Research Site
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Clinical Research Site
    • New York
      • Brooklyn, New York, United States, 11230
        • Clinical Research Site
      • New Hyde Park, New York, United States, 11040
        • Clinical Research Site
    • North Carolina
      • Denver, North Carolina, United States, 28037
        • Clinical Research Site
      • Gastonia, North Carolina, United States, 28054
        • Clinical Research Site
      • Huntersville, North Carolina, United States, 28078
        • Clinical Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Clinical Research Site
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Clinical Research Site
      • Columbia, South Carolina, United States, 29201
        • Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Clinical Research Site
      • San Antonio, Texas, United States, 78229
        • Clinical Research Site
      • Sugar Land, Texas, United States, 77478
        • Clinical Research Site
    • Virginia
      • Williamsburg, Virginia, United States, 23188
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Up to 5 weeks
Drug: Placebo
Placebo tablets, taken twice daily
Experimental: AXS-12 (reboxetine)
Up to 5 weeks
Drug: AXS-12 (reboxetine)
AXS-12 tablets, taken twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of cataplexy attacks
Time Frame: Change from Baseline to Week 5
Average number of cataplexy attacks per week
Change from Baseline to Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-12-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Narcolepsy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe