Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Status:
Completed
Trial end date:
2019-11-27
Target enrollment:
Participant gender:
Summary
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.