Cataplexy, Excessive Daytime Sleepiness, Narcolepsy
Conditions
Keywords
AXS-12, Narcolepsy, Cataplexy, Excessive daytime sleepiness, Reboxetine, Axsome
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.
Interventions
AXS-12 tablets, taken twice daily
DRUGPlacebo
Placebo tablets, taken twice daily
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of cataplexy attacks | Change from Baseline to Week 5 | Average number of cataplexy attacks per week |
Countries
Canada, United States
Outcome results
None listed