Phase 2 Trial Results for New Potential Narcolepsy Treatment Will be Here Soon!

Narcolepsy and Cataplexy

Narcolepsy is a neurological condition that results in a malfunctioning sleep-wake cycle. It affects approximately 185,000 individuals in the United States alone. Some of the most common symptoms of the condition include cataplexy, sleep paralysis, hypnagogic hallucinations, disrupted sleep during the night, and excessive sleepiness during the day. These symptoms can be debilitating and spark depression in approximately 57% of patients. It can also impair social, cognitive, and psychological functioning as well as increase the risk of car accidents. 

Cataplexy is one of the most severe of the symptoms associated with this disease. It affects around 70% of all patients. It refers to episodes of sudden and uncontrollable muscle weakness. These attacks occur when the individual is awake. They are triggered by any intense emotion such as excitement, stress, fear, laughter, or anger. 

While there are some treatment options for narcolepsy and cataplexy, they all have limitations. 

Axsome Therapeutics has just developed a new treatment that they believe could be a better option for narcolepsy and cataplexy patients. This treatment is called AXS-12. It has already received Orphan Drug Designation by the FDA and a Phase 2 trial of the drug has just been initiated. 

The Trial

This Phase 2 trial is planning to enroll 20 patients. It will be conducted at multiple trial centers. All of the participants will receive AXS-12 for three weeks and placebo for three weeks. However, it will be randomized which patient receives which treatment first. Participants will be monitored to assess the impact of the treatment on their narcolepsy symptoms. One of the examinations will document how frequently cataplexy attacks occur. 

AXS-12 is a potent norepinephrine reuptake inhibitor. It is unique because researchers believe it could be effective for treating some of the worst narcolepsy symptoms while simultaneously not causing any of the limitations that are produced by other treatments currently on the market. 

Axsome Therapeutics expects to receive results from this trial by the second quarter of 2019. If positive, AXS-12 will continue to be investigated as a potential treatment option for those living with narcolepsy. 

You can read more about AXS-12 and its Phase 2 trial here.


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