A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects with Narcolepsy (ENCORE)
Phase 3
Completed
- Conditions
- NarcolepsyExcessive Daytime SleepinessCataplexy
- Interventions
- Drug: AXS-12 (reboxetine)Drug: Placebo
- Registration Number
- NCT05113745
- Lead Sponsor
- Axsome Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AXS-12 (reboxetine) AXS-12 (reboxetine) * Up to 24 weeks in open-label period * Up to 4 weeks in randomized double-blind period Placebo Placebo Up to 4 weeks in randomized double-blind period
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Site
🇨🇦Toronto, Ontario, Canada