Overview

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