Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced the completion 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.
About the CONCERT Trial
CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. The study will enroll approximately 20 patients, all of whom 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.