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

Phase 3

Completed

• Conditions: Narcolepsy; Cataplexy; Excessive Daytime Sleepiness
• Interventions: Drug: AXS-12 (reboxetine); Drug: Placebo

• Registration Number: NCT05059223
• Lead Sponsor: Axsome Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2021-09-09
• Study Start: 2021-09-15
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-28
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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Exclusion Criteria

• Other clinically significant conditions potentially causing EDS
• Clinically significant psychiatric disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXS-12 (reboxetine)	AXS-12 (reboxetine)	Up to 5 weeks
Placebo	Placebo	Up to 5 weeks

Primary Outcome Measures

Name	Time	Method
Frequency of cataplexy attacks	Change from Baseline to Week 5	Average number of cataplexy attacks per week

Trial Locations

Locations (1)

Clinical Research Site; 🇨🇦 Toronto, Ontario, Canada