Axsome Therapeutics Inc has completed of patient enrollment in the CONCERT study, a Phase 2, randomized, double-blind, placebo-controlled, crossover, trial of AXS-12 in patients with narcolepsy. AXS-12 (reboxetine) is a novel, oral, potent and highly selective norepinephrine reuptake inhibitor for the treatment of narcolepsy. Axsome remains on track to report topline results from CONCERT in the fourth quarter of 2019.
Study participants will be treated with AXS-12 for three weeks, and with placebo for three weeks. Eligible patients will be randomized to receive either AXS-12 followed by placebo, or placebo followed by AXS-12. Efficacy assessments will include the frequency of cataplexy attacks and measures of other symptoms of narcolepsy.