Cataplexy, Excessive Daytime Sleepiness, Narcolepsy
Conditions
Keywords
AXS-12, Narcolepsy, Cataplexy, Excessive Daytime Sleepiness, Reboxetine, Axsome
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.
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)
Intervention model description
Open-label treatment period, followed by a double-blind treatment period.
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term safety as measured by the incidence of treatment-emergent adverse events | Up to 28 weeks |
| Efficacy as measured by change in frequency of cataplexy attacks from baseline. | Baseline to Week 27 |
Countries
Canada, United States
Outcome results
None listed