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 (SYMPHONY)

  • STATUS
    Recruiting
  • End date
    Jun 10, 2023
  • participants needed
    90
  • sponsor
    Axsome Therapeutics, Inc.
Updated on 10 October 2022
somnolence
cataplexy

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).

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.

Details
Condition Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
Treatment Placebo, AXS-12 (Reboxetine)
Clinical Study IdentifierNCT05059223
SponsorAxsome Therapeutics, Inc.
Last Modified on10 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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