NCT05113745

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

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: 2021-10-20
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2021-11-09
• Last updated: 2025-11-13

Locations

25 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study