Phase 2 Trial for Narcolepsy has Completed Enrollment

Narcolepsy is a rare neurological disease that affects the sleep cycle. Symptoms include sleep paralysis, excessive daytime sleepiness, disrupted nighttime sleep, hypnagogic hallucinations, and, for around 70% of patients, cataplexy. Cataplexy is characterized by the sudden loss of muscle control while the patient is awake. These attacks are often triggered by intense emotions such as fear, excitement, or stress.

Narcolepsy can impact every aspect of a patient’s life including their cognition, psychological health, and social functioning. Individuals with narcolepsy have a higher risk of being involved in a car accident and are more likely to suffer from depression than the average person.

This patient population is in need of more therapeutic options which could improve their daily quality of life.

Thankfully, enrollment has just been completed in a Phase 2 trial, bringing a new treatment one step closer to patients.

About the Trial

This trial is called CONCERT. It was initiated by Axsome Therapeutics and is evaluating AXS-12. The trial includes 20 narcolepsy patients who will all be randomized to receive either three weeks of the treatment followed by three weeks of placebo, or the reverse.

AXS-12 has received Orphan Drug Designation by the FDA and researchers are hopeful about it is potential. Otherwise known as reboxetine, AXS-12 is an oral norepinephrine reuptake inhibitor.

Throughout this investigation, which is occurring at multiple trial sites, researchers will be examining various symptoms of narcolepsy including the frequency that patients experience cataplexy attacks.

 Axsome expects to report results from this trial by the last quarter of this year thanks to the new milestone they have reached- completed enrollment.

You can read more about this trial here.


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