A Phase 3 interventional study of AXS-12 (reboxetine) and Placebo in Narcolepsy, Cataplexy and Excessive Daytime Sleepiness, sponsored by Axsome Therapeutics, Inc.. Completed at 25 sites in 2 countries. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-13.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
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.
31 studies on the registry are indexed under Cataplexy; 5 are open to participants now.
This study's enrollment of 68 is below the median of 117 across 27 interventional studies indexed under Cataplexy.
Browse Cataplexy studies →Axsome Therapeutics, Inc. is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 12 (57%) have results posted.
Compared within Cataplexy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Narcolepsy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
* Up to 24 weeks in open-label period * Up to 4 weeks in randomized double-blind period
Drug: AXS-12 (reboxetine)
Up to 4 weeks in randomized double-blind period
Drug: Placebo
AXS-12 tablets, taken twice daily
Placebo tablets, taken twice daily
Long-term safety as measured by the incidence of treatment-emergent adverse events
Time frame: Up to 28 weeks
Efficacy as measured by change in frequency of cataplexy attacks from baseline.
Time frame: Baseline to Week 27
Plan to share: No
Ran from Oct 2021 to primary completion in Nov 2024, 36 months.
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Reboxetine