clinical trial · NCT05113745
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
NarcolepsyCataplexyExcessive Daytime SleepinessAXS-12 (reboxetine)Placebo
brief summary
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
started
Oct 20, 2021
primary completion
Nov 15, 2024
completion
Nov 15, 2024
last updated
Nov 13, 2025
detailed 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.
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol