Clinical trial NCT05059223: A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects With Narcolepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Narcolepsy
Cataplexy
Excessive Daytime Sleepiness
Keywords: AXS-12
Narcolepsy
Cataplexy
Excessive daytime sleepiness
Reboxetine
Axsome
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-28
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of cataplexy attacks
timeFrame: Change from Baseline to Week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Clinical Research Site
state: Alabama
city: Peoria
country: United States
facility: Clinical Research Site
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Site
state: Arizona
city: Redwood City
country: United States
facility: Clinical Research Site
state: California
city: San Diego
country: United States
facility: Clinical Research Site
state: California
city: Santa Ana
country: United States
facility: Clinical Research Site
state: California
city: Santa Monica
country: United States
facility: Clinical Research Site
state: California
city: Boulder
country: United States
facility: Clinical Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Clinical Research Site
state: Colorado
city: Brandon
country: United States
facility: Clinical Research Site
state: Florida
city: Clearwater
country: United States
facility: Clinical Research Site
state: Florida
city: Doral
country: United States
facility: Clinical Research Site
state: Florida
city: Kissimmee
country: United States
facility: Clinical Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Clinical Research Site
state: Florida
city: Tampa
country: United States
facility: Clinical Research Site
state: Florida
city: Winter Park
country: United States
facility: Clinical Research Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Research Site
state: Georgia
city: Atlanta
country: United States
facility: Clinical Research Site
state: Georgia
city: Gainesville
country: United States
facility: Clinical Research Site
state: Georgia
city: Macon
country: United States
facility: Clinical Research Site
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Site
state: Georgia
city: Honolulu
country: United States
facility: Clinical Research Site
state: Hawaii
city: Peoria
country: United States
facility: Clinical Research Site
state: Illinois
city: Fort Wayne
country: United States
facility: Clinical Research Site
state: Indiana
city: Chevy Chase
country: United States
facility: Clinical Research Site
state: Maryland
city: Newton
country: United States
facility: Clinical Research Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Clinical Research Site
state: Michigan
city: Novi
country: United States
facility: Clinical Research Site
state: Michigan
city: Maplewood
country: United States
facility: Clinical Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Site
state: Nevada
city: West Long Branch
country: United States
facility: Clinical Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Clinical Research Site
state: New York
city: New Hyde Park
country: United States
facility: Clinical Research Site
state: New York
city: Denver
country: United States
facility: Clinical Research Site
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research Site
state: North Carolina
city: Huntersville
country: United States
facility: Clinical Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Research Site
state: Ohio
city: Wyomissing
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Site
state: South Carolina
city: Columbia
country: United States
facility: Clinical Research Site
state: South Carolina
city: Austin
country: United States
facility: Clinical Research Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
city: Sugar Land
country: United States
facility: Clinical Research Site
state: Texas
city: Williamsburg
country: United States
facility: Clinical Research Site
state: Virginia
city: Markham
country: Canada
facility: Clinical Research Site
state: Ontario
city: Toronto
country: Canada
facility: Clinical Research Site
state: Ontario
city: Toronto
country: Canada
facility: Clinical Research Site
state: Ontario
Study officials:
References: