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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05059223
Other study ID # AXS-12-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 15, 2021
Est. completion date June 2023

Study information

Verified date March 2023
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone 212-332-5061
Email SYMPHONYstudy@axsome.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 15 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
AXS-12 (reboxetine)
AXS-12 tablets, taken twice daily
Placebo
Placebo tablets, taken twice daily

Locations

Country Name City State
Canada Clinical Research Site Markham Ontario
Canada Clinical Research Site Toronto Ontario
Canada Clinical Research Site Toronto Ontario
United States Clinical Research Site Alabaster Alabama
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Austin Texas
United States Clinical Research Site Boulder Colorado
United States Clinical Research Site Brandon Florida
United States Clinical Research Site Charleston South Carolina
United States Clinical Research Site Chevy Chase Maryland
United States Clinical Research Site Cincinnati Ohio
United States Clinical Research Site Clearwater Florida
United States Clinical Research Site Colorado Springs Colorado
United States Clinical Research Site Columbia South Carolina
United States Clinical Research Site Denver North Carolina
United States Clinical Research Site Fort Wayne Indiana
United States Clinical Research Site Gastonia North Carolina
United States Clinical Research Site Honolulu Hawaii
United States Clinical Research Site Huntersville North Carolina
United States Clinical Research Site Kalamazoo Michigan
United States Clinical Research Site Kissimmee Florida
United States Clinical Research Site Las Vegas Nevada
United States Clinical Research Site Macon Georgia
United States Clinical Research Site Maplewood Missouri
United States Clinical Research Site Miami Florida
United States Clinical Research Site Miami Lakes Florida
United States Clinical Research Site New Hyde Park New York
United States Clinical Research Site Newton Massachusetts
United States Clinical Research Site North Dartmouth Massachusetts
United States Clinical Research Site Novi Michigan
United States Clinical Research Site Peoria Illinois
United States Clinical Research Site Peoria Arizona
United States Clinical Research Site Phoenix Arizona
United States Clinical Research Site Redwood City California
United States Clinical Research Site Saint Petersburg Florida
United States Clinical Research Site San Antonio Texas
United States Clinical Research Site San Diego California
United States Clinical Research Site Santa Ana California
United States Clinical Research Site Santa Monica California
United States Clinical Research Site Stockbridge Georgia
United States Clinical Research Site Sugar Land Texas
United States Clinical Research Site Tampa Florida
United States Clinical Research Site West Long Branch New Jersey
United States Clinical Research Site Williamsburg Virginia
United States Clinical Research Site Winter Park Florida
United States Clinical Research Site Wyomissing Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of cataplexy attacks Average number of cataplexy attacks per week Change from Baseline to Week 5
See also
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Completed NCT00132873 - Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy Phase 3
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Enrolling by invitation NCT05113745 - A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy Phase 3
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
Recruiting NCT04899947 - Child and Adolescent Registry for Participants With Narcolepsy