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

Axsome Therapeutics

Status and phase: Completed; Phase 3

Conditions: Cataplexy; Excessive Daytime Sleepiness; Narcolepsy

Treatments: Drug: Placebo; Drug: AXS-12 (reboxetine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05059223

AXS-12-301

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

AXS-12 (reboxetine)

Experimental group

Description:

Up to 5 weeks

Treatment:

Drug: AXS-12 (reboxetine)

Placebo

Placebo Comparator group

Description:

Up to 5 weeks

Treatment:

Drug: Placebo