A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects with Narcolepsy (ENCORE)

Axsome Therapeutics

Status and phase: Completed; Phase 3

Conditions: Cataplexy; Excessive Daytime Sleepiness; Narcolepsy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05113745

AXS-12-302

Details and patient eligibility

About

This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Full description

This study is a multi-center trial consisting of a 24-week open-label period, followed by a 4-week double-blind, placebo-controlled, randomized withdrawal period. At the Week 24 visit, subjects will be randomized in a 1:1 ratio either to continue to receive AXS-12 or to switch to placebo, for the next 4 weeks. Eligible subjects will have previously participated in the AXS-12-301 study.

Enrollment: 68 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed the treatment period of Study AXS-12-301
• Willing and able to comply with the study requirements

Exclusion criteria

• Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

AXS-12 (reboxetine)

Experimental group

Description:

* Up to 24 weeks in open-label period * Up to 4 weeks in randomized double-blind period

Treatment:

Drug: AXS-12 (reboxetine)

Placebo

Placebo Comparator group

Description:

Up to 4 weeks in randomized double-blind period

Treatment:

Drug: Placebo