A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
SYMPHONY
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
1 other identifier
interventional
90
2 countries
50
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2021
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2021
CompletedStudy Start
First participant enrolled
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
September 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedMarch 19, 2025
March 1, 2025
2.5 years
September 9, 2021
March 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of cataplexy attacks
Average number of cataplexy attacks per week
Change from Baseline to Week 5
Study Arms (2)
AXS-12 (reboxetine)
EXPERIMENTALUp to 5 weeks
Placebo
PLACEBO COMPARATORUp to 5 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Other clinically significant conditions potentially causing EDS
- Clinically significant psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Clinical Research Site
Alabaster, Alabama, 35007, United States
Clinical Research Site
Peoria, Arizona, 85381, United States
Clinical Research Site
Phoenix, Arizona, 85054, United States
Clinical Research Site
Redwood City, California, 94063, United States
Clinical Research Site
San Diego, California, 92103, United States
Clinical Research Site
Santa Ana, California, 92705, United States
Clinical Research Site
Santa Monica, California, 90404, United States
Clinical Research Site
Boulder, Colorado, 80301, United States
Clinical Research Site
Colorado Springs, Colorado, 80918, United States
Clinical Research Site
Brandon, Florida, 33511, United States
Clinical Research Site
Clearwater, Florida, 33765, United States
Clinical Research Site
Doral, Florida, 33122, United States
Clinical Research Site
Kissimmee, Florida, 34741, United States
Clinical Research Site
Miami, Florida, 33176, United States
Clinical Research Site
Miami Lakes, Florida, 33016, United States
Clinical Research Site
St. Petersburg, Florida, 33707, United States
Clinical Research Site
Tampa, Florida, 33634, United States
Clinical Research Site
Winter Park, Florida, 32789, United States
Clinical Research Site
Atlanta, Georgia, 30315, United States
Clinical Research Site
Atlanta, Georgia, 30328, United States
Clinical Research Site
Gainesville, Georgia, 30501, United States
Clinical Research Site
Macon, Georgia, 31210, United States
Clinical Research Site
Stockbridge, Georgia, 30281, United States
Clinical Research Site
Honolulu, Hawaii, 96817, United States
Clinical Research Site
Peoria, Illinois, 61637, United States
Clinical Research Site
Fort Wayne, Indiana, 46804, United States
Clinical Research Site
Chevy Chase, Maryland, 20815, United States
Clinical Research Site
Newton, Massachusetts, 02459, United States
Clinical Research Site
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Site
Kalamazoo, Michigan, 49008, United States
Clinical Research Site
Novi, Michigan, 48377, United States
Clinical Research Site
Maplewood, Missouri, 63143, United States
Clinical Research Site
Las Vegas, Nevada, 89106, United States
Clinical Research Site
West Long Branch, New Jersey, 07764, United States
Clinical Research Site
Brooklyn, New York, 11230, United States
Clinical Research Site
New Hyde Park, New York, 11040, United States
Clinical Research Site
Denver, North Carolina, 28037, United States
Clinical Research Site
Gastonia, North Carolina, 28054, United States
Clinical Research Site
Huntersville, North Carolina, 28078, United States
Clinical Research Site
Cincinnati, Ohio, 45245, United States
Clinical Research Site
Wyomissing, Pennsylvania, 19610, United States
Clinical Research Site
Charleston, South Carolina, 29425, United States
Clinical Research Site
Columbia, South Carolina, 29201, United States
Clinical Research Site
Austin, Texas, 78731, United States
Clinical Research Site
San Antonio, Texas, 78229, United States
Clinical Research Site
Sugar Land, Texas, 77478, United States
Clinical Research Site
Williamsburg, Virginia, 23188, United States
Clinical Research Site
Markham, Ontario, L3R 1A3, Canada
Clinical Research Site
Toronto, Ontario, M4P 1P2, Canada
Clinical Research Site
Toronto, Ontario, M5S 3A3, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2021
First Posted
September 28, 2021
Study Start
September 15, 2021
Primary Completion
March 15, 2024
Study Completion
March 15, 2024
Last Updated
March 19, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share