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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05059223
Recruitment Status : Recruiting
First Posted : September 28, 2021
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Narcolepsy Cataplexy Excessive Daytime Sleepiness Drug: AXS-12 (reboxetine) Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AXS-12 (reboxetine)
Up to 5 weeks
Drug: AXS-12 (reboxetine)
AXS-12 tablets, taken twice daily

Placebo Comparator: Placebo
Up to 5 weeks
Drug: Placebo
Placebo tablets, taken twice daily




Primary Outcome Measures :
  1. Frequency of cataplexy attacks [ Time Frame: Change from Baseline to Week 5 ]
    Average number of cataplexy attacks per week



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05059223


Contacts
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Contact: Study Director 212-332-3223 SYMPHONYstudy@axsome.com

Locations
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United States, Alabama
Clinical Research Site Recruiting
Alabaster, Alabama, United States, 35007
United States, Arizona
Clinical Research Site Recruiting
Peoria, Arizona, United States, 85381
United States, California
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San Diego, California, United States, 92103
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Santa Ana, California, United States, 92705
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Santa Monica, California, United States, 90404
United States, Colorado
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Colorado Springs, Colorado, United States, 80918
United States, Florida
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Brandon, Florida, United States, 33511
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Clearwater, Florida, United States, 33765
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Kissimmee, Florida, United States, 34741
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Miami, Florida, United States, 33176
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Tampa, Florida, United States, 33634
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Winter Park, Florida, United States, 32789
United States, Georgia
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Atlanta, Georgia, United States, 30315
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Atlanta, Georgia, United States, 30328
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Macon, Georgia, United States, 31210
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Stockbridge, Georgia, United States, 30281
United States, Hawaii
Clinical Research Site Recruiting
Honolulu, Hawaii, United States, 96817
United States, Illinois
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Peoria, Illinois, United States, 61637
United States, Maryland
Clinical Research Site Recruiting
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
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Newton, Massachusetts, United States, 02459
Clinical Research Site Recruiting
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Clinical Research Site Recruiting
Kalamazoo, Michigan, United States, 49008
United States, Missouri
Clinical Research Site Recruiting
Maplewood, Missouri, United States, 63143
United States, Nevada
Clinical Research Site Recruiting
Las Vegas, Nevada, United States, 89106
United States, New York
Clinical Research Site Recruiting
New Hyde Park, New York, United States, 11040
United States, North Carolina
Clinical Research Site Recruiting
Denver, North Carolina, United States, 28037
Clinical Research Site Recruiting
Gastonia, North Carolina, United States, 28054
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Huntersville, North Carolina, United States, 28078
United States, Ohio
Clinical Research Site Recruiting
Cincinnati, Ohio, United States, 45245
United States, Pennsylvania
Clinical Research Site Recruiting
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Clinical Research Site Recruiting
Columbia, South Carolina, United States, 29201
United States, Texas
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Austin, Texas, United States, 78731
Clinical Research Site Recruiting
San Antonio, Texas, United States, 78229
Canada, Ontario
Clinical Research Site Recruiting
Markham, Ontario, Canada, L3R 1A3
Clinical Research Site Recruiting
Toronto, Ontario, Canada, M4P 1P2
Clinical Research Site Recruiting
Toronto, Ontario, Canada, M5S 3A3
Sponsors and Collaborators
Axsome Therapeutics, Inc.
Additional Information:
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Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05059223    
Other Study ID Numbers: AXS-12-301
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axsome Therapeutics, Inc.:
AXS-12
Narcolepsy
Cataplexy
Excessive daytime sleepiness
Reboxetine
Axsome
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Cataplexy
Sleepiness
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs