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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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05059223
Study type Interventional
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone 212-332-3223
Email [email protected]
Status Recruiting
Phase Phase 3
Start date September 15, 2021
Completion date June 2023

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