Clinical trial NCT05113745: A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects with Narcolepsy (ENCORE)
Official title: A Study to Assess the Long-term 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: 2021-11-09
Enrollment: 68
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
Intervention model description: Open-label treatment period, followed by a double-blind treatment period.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Long-term safety as measured by the incidence of treatment-emergent adverse events
timeFrame: Up to 28 weeks
measure: Efficacy as measured by change in frequency of cataplexy attacks from baseline.
timeFrame: Baseline to Week 27
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Clinical Research Site
state: Arizona
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: Miami Lakes
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: Stockbridge
country: United States
facility: Clinical Research Site
state: Georgia
city: Chevy Chase
country: United States
facility: Clinical Research Site
state: Maryland
city: Kalamazoo
country: United States
facility: Clinical Research Site
state: Michigan
city: Novi
country: United States
facility: Clinical Research Site
state: Michigan
city: Neptune City
country: United States
facility: Clinical Research Site
state: New Jersey
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: Toronto
country: Canada
facility: Clinical Research Site
state: Ontario
Study officials:
References: