Loading clinical trials...
Loading clinical trials...
A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
This study is a multi-center trial consisting of a 24-week open-label period, followed by a 4-week double-blind, placebo-controlled, randomized withdrawal period. At the Week 24 visit, subjects will be randomized in a 1:1 ratio either to continue to receive AXS-12 or to switch to placebo, for the next 4 weeks. Eligible subjects will have previously participated in the AXS-12-301 study.
Age
15 - 75 years
Sex
ALL
Healthy Volunteers
No
Clinical Research Site
Phoenix, Arizona, United States
Clinical Research Site
Boulder, Colorado, United States
Clinical Research Site
Colorado Springs, Colorado, United States
Clinical Research Site
Brandon, Florida, United States
Clinical Research Site
Clearwater, Florida, United States
Clinical Research Site
Doral, Florida, United States
Clinical Research Site
Miami Lakes, Florida, United States
Clinical Research Site
Winter Park, Florida, United States
Clinical Research Site
Atlanta, Georgia, United States
Clinical Research Site
Atlanta, Georgia, United States
Start Date
October 20, 2021
Primary Completion Date
November 15, 2024
Completion Date
November 15, 2024
Last Updated
November 13, 2025
68
ACTUAL participants
AXS-12 (reboxetine)
DRUG
Placebo
DRUG
Lead Sponsor
Axsome Therapeutics, Inc.
NCT07363720
NCT06952699
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06809803