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

Narcolepsy Clinical Trial

Official title:
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

Clinical Trial Summary

This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05113745
Study type Interventional
Source Axsome Therapeutics, Inc.
Contact
Status Enrolling by invitation
Phase Phase 3
Start date October 20, 2021
Completion date December 2024
View Details
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