NCT05059223
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- AXS-12 (reboxetine)
- Conditions
- Narcolepsy
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Frequency of cataplexy attacks
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
AXS-12 (reboxetine)
Up to 5 weeks
Intervention: AXS-12 (reboxetine)
Placebo
Up to 5 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Frequency of cataplexy attacks
Time Frame: Change from Baseline to Week 5
Average number of cataplexy attacks per week
Study Sites (1)
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