clinical trial · NCT05059223
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
NarcolepsyCataplexyExcessive Daytime SleepinessAXS-12 (reboxetine)Placebo
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).
started
Sep 15, 2021
primary completion
Mar 15, 2024
completion
Mar 15, 2024
last updated
Mar 19, 2025
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.
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol