Trial Profile
A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 28 Aug 2023
Price :
$35
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At a glance
- Drugs Reboxetine (Primary)
- Indications Cataplexy; Narcolepsy
- Focus Therapeutic Use
- Acronyms CONCERT
- Sponsors Axsome Therapeutics
- 28 Aug 2020 According to an Axsome Therapeutics media release, data from the study will be presented at the 34th Annual SLEEP Meeting of the Associated Professional Sleep Societies (APSS) 2020. A copy of the presentation will be available shortly after the meeting on Axsome's website at www.axsome.com.
- 05 Aug 2020 According to an Axsome Therapeutics media release, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in patients with narcolepsy, based on data from this trial.
- 11 Jan 2020 Status changed from active, no longer recruiting to completed.