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Completed

NCT Number: NCT05059223

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

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).

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Key information

Conditions

Narcolepsy Cataplexy Disorders of Excessive Somnolence Dyssomnias Excessive Daytime Sleepiness Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Markham, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AXS-12 (reboxetine)

Drug

AXS-12 tablets, taken twice daily

Placebo

Drug

Placebo tablets, taken twice daily

Primary outcomes

  1. Frequency of cataplexy attacks

    Time frame: Change from Baseline to Week 5

    Average number of cataplexy attacks per week

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: SYMPHONY

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2021
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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