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

Axsome Therapeutics, Inc.68 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Narcolepsy Cataplexy Excessive Daytime Sleepiness

Interventions

AXS-12 (reboxetine)DRUG

AXS-12 tablets, taken twice daily

PlaceboDRUG

Placebo tablets, taken twice daily

Eligibility

Sex: ALLMin age: 15 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (25)

Clinical Research Site

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Long-term safety as measured by the incidence of treatment-emergent adverse events

Time frame: Up to 28 weeks

Efficacy as measured by change in frequency of cataplexy attacks from baseline.

Time frame: Baseline to Week 27

Data from ClinicalTrials.gov

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