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 50 sites in 2 countries. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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).
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.
31 studies on the registry are indexed under Cataplexy; 5 are open to participants now.
This study's enrollment of 90 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Up to 5 weeks
Drug: AXS-12 (reboxetine)
Up to 5 weeks
Drug: Placebo
AXS-12 tablets, taken twice daily
Placebo tablets, taken twice daily
Frequency of cataplexy attacks
Average number of cataplexy attacks per week
Time frame: Change from Baseline to Week 5
Plan to share: No
Ran from Sep 2021 to primary completion in Mar 2024, 30 months.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Reboxetine