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

Primary Purpose

Narcolepsy, Cataplexy, Excessive Daytime Sleepiness

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AXS-12 (reboxetine)
Placebo
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narcolepsy focused on measuring AXS-12, Narcolepsy, Cataplexy, Excessive daytime sleepiness, Reboxetine, Axsome

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AXS-12 (reboxetine)

Placebo

Arm Description

Up to 5 weeks

Up to 5 weeks

Outcomes

Primary Outcome Measures

Frequency of cataplexy attacks
Average number of cataplexy attacks per week

Secondary Outcome Measures

Full Information

First Posted
September 9, 2021
Last Updated
March 3, 2023
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05059223
Brief Title
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
Acronym
SYMPHONY
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
Keywords
AXS-12, Narcolepsy, Cataplexy, Excessive daytime sleepiness, Reboxetine, Axsome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AXS-12 (reboxetine)
Arm Type
Experimental
Arm Description
Up to 5 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Up to 5 weeks
Intervention Type
Drug
Intervention Name(s)
AXS-12 (reboxetine)
Intervention Description
AXS-12 tablets, taken twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets, taken twice daily
Primary Outcome Measure Information:
Title
Frequency of cataplexy attacks
Description
Average number of cataplexy attacks per week
Time Frame
Change from Baseline to Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
212-332-5061
Email
SYMPHONYstudy@axsome.com
Facility Information:
Facility Name
Clinical Research Site
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30315
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Maplewood
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28037
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23188
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3R 1A3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 1P2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3A3
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://SYMPHONYstudy.com
Description
SYMPHONY Study Website
URL
http://www.axsome.com
Description
Axsome Therapeutics Website

Learn more about this trial

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

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