Axsome Therapeutics has commenced the Phase II Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) trial evaluating AXS-12 (reboxetine) for the treatment of narcolepsy.
Narcolepsy is a neurological condition that leads to dysregulation of the sleep-wake cycle. It is characterised by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, and other conditions.
The CONCERT study features a double-blind, placebo-controlled, multicentre design and is expected to enrol around 20 patients who will receive AXS-12 and placebo for three weeks.
Patients will be randomised to receive either AXS-12 followed by placebo or placebo followed by AXS-12.
The crossover trial’s efficacy endpoints will include the frequency of cataplexy attacks and identifying other symptoms of narcolepsy.
Topline data from the trial is expected to be available in the second quarter of this year.
Axsome Therapeutics CEO Herriot Tabuteau said: “The initiation of the CONCERT trial of AXS-12 for the treatment of narcolepsy reflects Axsome’s advancing pipeline of differentiated central nervous system CNS product candidates, and our continued commitment to developing novel medicines to improve the lives of patients living with serious and difficult-to-treat CNS disorders.
“The CONCERT trial utilises an efficient crossover design to improve signal detection and speed trial conduct.”
AXS-12 has received orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of narcolepsy.
Axsome Therapeutics Clinical Development and Medical Affairs senior vice-president Cedric O’Gorman said: “Narcolepsy is debilitating for the nearly 200,000 individuals living with this condition in the US.
“Unfortunately, treatment options for these patients are limited.
“AXS-12 has the potential to address the key symptoms of this disorder and may not share the limitations of currently approved agents.”