NCT05059223

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Narcolepsy
• Cataplexy
• Excessive Daytime Sleepiness

Interventions

Type	Name	Description
DRUG	AXS-12 (reboxetine)	AXS-12 tablets, taken twice daily
DRUG	Placebo	Placebo tablets, taken twice daily

Timeline

• Start date: 2021-09-15
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2021-09-28
• Last updated: 2025-03-19

Locations

50 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study