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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axsome Therapeutics, Inc.
• Treatments: Reboxetine

Criteria

Inclusion Criteria:

• Male or female subjects between 15 and 75 years of age, inclusive

• Primary diagnosis of narcolepsy with cataplexy

• Willing and able to comply with the study requirements

Exclusion Criteria:

• Other clinically significant conditions potentially causing EDS

• Clinically significant psychiatric disorders