CompletedPhase 3

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

United States90 participantsStarted 2021-09-15

Plain-language 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).

Who can participate

Age range15 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Frequency of cataplexy attacks

Timeframe: Change from Baseline to Week 5

Trial details

NCT IDNCT05059223

SponsorAxsome Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-15

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