This trial is evaluating whether JZP-258 will improve 1 primary outcome and 9 secondary outcomes in patients with Narcolepsy. Measurement will happen over the course of Baseline to Week 8.
This trial requires 100 total participants across 2 different treatment groups
This trial involves 2 different treatments. JZP-258 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
In our sample, the incidence of Narcolepsy was approximately 4.7% in our population. The gender incidence ratio was 1.07; the age incidence rate was 63 + 16 yr. and the mean age was 44 yr. There was no familial occurrence of Narcolepsy. To the authors' knowledge, this is the first report of the occurrence of Narcolepsy in a general population of Indians.
About 100,950 people in the United States are diagnosed with narcolepsy. A major cause of sleepiness is central sleep apnea as seen in narcolepsy. To prevent narcolepsy, treatment of narcolepsy should be initiated in childhood.
Narcolepsy can be highly severe, and while some patients can be treated effectively and sustain a long-term remission, others have no response to pharmacological therapy, and may be advised to adopt a life-long medical and behavioral approach.
Sleep-disordered breathing is a common, treatable pathologic manifestation of narcolepsy. The narcolepsy-cataplexy syndrome shares a common pathogenesis with other narcolepsy symptoms, such as excessive daytime sleepiness, hypersomnia, and hypnagogic hallucinations. These symptoms, though different features of narcolepsy disease presentation, may indicate a common underlying pathophysiology.
Many patients have comorbid anxiety or depression. Treatment should be customized to each patient's specific needs. Sleep medicine is focused on treating the individual's daytime sleepiness and controlling the symptoms of the disorder. This includes managing symptoms and optimizing compliance with sleep medications. Cognitive behavioral therapy is used to reduce or eliminate avoidance of the symptom triggering triggers of narcolepsy. Medications used to control comorbid symptoms include stimulants such as methylphenidate. Sleep hygiene can be addressed through the following: sleep hygiene education, sleep hygiene counseling, and sleep hygiene education on the importance of adherence to sleep hygiene recommendations.
The signs of narcolepsy are fatigue, hypersomnia, and cataplexy. It is important to recognize the symptoms of narcolepsy among all patients admitted to the intensive care department for one week. Narcolepsy is a multisystem disease with many possible symptoms such as headaches, irritability, vomiting, and depression.
Clinical trials should be run as part of patient education for people with narcolepsy as a part of the management of chronic disabling sleepiness. The primary goal of narcolepsy trials is to determine if any treatment can prevent the development of cataplexy and/or enhance the recovery time after a cataplexy attack. Clinical trials should also evaluate for an effect on sleep quality, alertness, mood, cognition, and energy level in narcoleptics with normal sleepiness who have moderate to severe disabling sleepiness of several months' duration.
A large dose of Jzp-258 was safe. There were only one or two symptomatic patients, and no serious adverse effects in any of the other patients on that study. The only side-effect reported was mild nasal congestion. Neither the authors nor the manufacturer have any other data. They are unaware of any previous studies of these same patients.
This proof-of-concept study demonstrated a significantly improved quality of life in response to Jzp-258 treatment versus placebo treatment. Jzp-258 should gain interest from researchers as a potential therapeutic agent for patients with narcolepsy who have reported a reduction in the severity of their sleep impairment and an improvement in the amount and quality of sleep while using the current pharmacological treatment of sleepiness.
Narcolepsy is serious and life-threatening. Patients and treatment providers must be aware that narcolepsy can be fatal. Narcolepsy patients tend to die in four main situations: overdose of medication; suicide; motor vehicle accidents; and (rarely) suicide by jumping. It is important to be aware of potential complications and treatment options so that patients can keep their sleep habits as well as their quality of life balanced. Patients with Narcolepsy are at risk for a variety of other serious adverse health effects. For a select group of patients who may be considered at heightened risk, a more proactive approach may be reasonable, considering the potential risks.
Since there is no cure for narcolepsy, there are many treatments to control symptoms and help patients live better. In narcolepsy, there are two ways to diagnose: clinical and objective sleep study. Narcolepsy is more diagnosed in males than in females. Treatment options are medication, surgery and behavioral intervention. Some medications used include MCT/BCT, adderall, and medication options such as modafinil, yohimbine, and naltrexone. Narcolepsy may be mistaken for the REM sleep behavior disorder.\n\nHypersomnia: The first case of hypersomnia was first described and named by John F. Clark in 1962 by Clark et al.