History or presence of any unstable or clinically significant medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or history or presence of another neurological disorder or surgical history that might affect the subject's safety and/or interfere with the conduct of the study in the opinion of the Investigator.Narcolepsy secondary to another medical condition (e.g., CNS injury or lesion).Willing and able to provide written informed consent.Willing and able to comply with the study design schedule and other requirements.If applicable, treated with a stimulant or alerting agent at unchanged doses for at least 2 months prior to dosing or not treated with a stimulant or alerting agent.Have a primary diagnosis of narcolepsy with cataplexy that meets ICSD-3 criteria or DSM-5 criteria, and currently untreated or treated with or without anticataplectics.Male or female subjects between 18 and 70 years of age, inclusive.Change in 5-level EQ-5D (EQ-5D-5L) Crosswalk Index Score and Visual Analog Scale.Higher scores indicate better health status. Summations of item scores were transformed into a range from 0 to 100 zero= worst HRQL, 100=best HRQL. none of the time, some of the time, etc.). Participants self-report on items in a summary that have between 2-6 choices per item (e.g. The Mental Component Summary component scale measures the impact of health and health-related changes on well-being, including vitality, social function, and emotional well-being. Physical Component Summary measures dimensions of functional health that are meaningful to respondents, including the impact of health and health-related changes on physical function, pain, and the ability to carry out daily roles. Two summary scores were derived using the SF-36v2. It yields an 8-scale profile of functional health and well-being scores as well as a psychometrically-based physical and mental overall component summary measures. The SF-36v2 is a multi-purpose, short-form health survey with 36 questions/ items. Subjects will return for a Safety Follow-up visit 2 weeks after the Open-Label Extension Period. During this period subjects will receive open label JZP-258. Subjects who complete the double-blind treatment period during the Main Study are eligible to enter a 24-week Open-Label Extension. Subjects will return for a Safety Follow-up visit 2 weeks after the Double-Blind Randomized-Withdrawal Period. Subjects are eligible to enter the Double-Blind Randomized-Withdrawal Period if the dose of JZP-258 remains unchanged during the Stable-Dose Period and, in the judgment of the Investigator, no clinically significant worsening in narcolepsy symptoms or clinically significant adverse events due to JZP-258 treatment have occurred. Once the JZP-258 dose has been optimized per the Investigator's judgment, these subjects may enter the 2-week Stable-Dose Period with that dose. They will be treated with JZP-258 alone for the final two weeks of this 12-week period. All subjects will begin JZP-258 treatment at the beginning of this period and continue through Week 12. Subjects will be transitioned to JZP-258 based on their treatment status at study entry. Why Should I Register and Submit Results?.347.11 Narcolepsy in conditions classified elsewhere, with cataplexy convert 347.347.10 Narcolepsy in conditions classified elsewhere, without cataplexy convert 347.10 to ICD-10-CM.347.1 Narcolepsy in conditions classified elsewhere.347.01 Narcolepsy, with cataplexy convert 347.01 to ICD-10-CM.347.00 Narcolepsy, without cataplexy convert 347.00 to ICD-10-CM.Recurrent, uncontrollable brief episodes of sleep and lapses in consciousness, often associated with hypnagogic hallucinations, cataplexy, automatic behaviors and sleep paralysis.The persons who suffer from this condition experience fatigue and may fall asleep at inappropriate times during the day. A sleep disorder characterized by a tendency for excessive sleepiness during the day which occurs even after adequate sleep in the nighttime.The pathophysiology of this disorder includes sleep-onset rapid eye movement (rem) sleep, which normally follows stage iii or iv sleep. Cataplexy sleep paralysis, and hypnagogic hallucinations frequently accompany narcolepsy. A condition characterized by recurrent episodes of daytime somnolence and lapses in consciousness (microsomnias) that may be associated with automatic behaviors and amnesia.
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