Type 1 narcolepsy in humans is widely believed to be caused as a result of loss of neurons in the brain that contain the key arousal neuropeptide Orexin (Orx also known as Hypocretin). Narcolepsy is a sleep disorder characterized by chronic and excessive daytime sleepiness, and sudden intrusion of sleep during wakefulness that can fall into two categories: type 1 and type 2. 3Wu Tsai Neurosciences Institute, Stanford University School of Medicine, Stanford, CA, United States.2Center for Sleep and Circadian Sciences, Stanford University School of Medicine, Stanford, CA, United States.1Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, United States.Neurology & Neuroscience Associates, Inc.Haniyyah Sardar 1,2,3, Andrea N. Raleigh, North Carolina, United States, 27607 Huntersville, North Carolina, United States, 28078 Rochester, New York, United States, 35058ĭurham, North Carolina, United States, 27710 Rochester, New York, United States, 14618 NYU-FGP Comphrenhensive Epilepsy Center-Sleep Center New Hyde Park, New York, United States, 11042 Kansas City, Missouri, United States, 64111 Rochester, Minnesota, United States, 55905Ĭhesterfield, Missouri, United States, 63017 Louisville, Kentucky, United States, 40218Ĭhevy Chase, Maryland, United States, 20815īoston, Massachusetts, United States, 02115Īnn Arbor, Michigan, United States, 48109īrooklyn Park, Minnesota, United States, 55443 Northbrook, Illinois, United States, 60062 NorthShore Uni HealthSys-Glenbrook Hospital Gainesville, Georgia, United States, 30501 Winter Park, Florida, United States, 32789 Sleep Medicine Specialists of South Florida, PA Jacksonville, Florida, United States, 32224 Norwalk, Connecticut, United States, 06850Ĭlearwater, Florida, United States, 33756 Santa Monica, California, United States, 90404 San Ramon, California, United States, 94583 Scottsdale, Arizona, United States, 85259 Phoenix, Arizona, United States, 85004-1150 Prior severe adverse reactions to CNS stimulants.īirmingham, Alabama, United States, 35213.Significant abnormality in the physical examination or clinical laboratory results.recent myocardial infarction), or QTc Fridericia higher than 450 ms for male and 470 ms for female (electrocardiogram Fridericia's corrected QT interval = QT / 3√ RR). syncope or arrhythmia) or any significant history of a serious abnormality of the ECG (e.g. Patients with a known history of long QTc syndrome (e.g.Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-V).The patient has a history of hypersensitivity or allergic reaction to pitolisant or any inactive ingredient of the formulation.The patient is at high risk for suicide defined as a suicide attempt within the past year, significant risk determined by the investigator interview, or use of the Columbia Suicide Severity Rating Scale (C-SSRS). The patient has, in the judgment of the treating physician, a history or current medical condition that could affect safety or poses an additional risk to the patient by their participation in the program.The patient is a woman who is breastfeeding or plans to breastfeed during their participation.The patient has severe hepatic impairment (Child-Pugh C).Due to the effectiveness of hormonal contraceptives potentially being reduced when used with pitolisant, alternative or concomitant barrier methods of contraception are required for patients taking hormonal contraceptives (e.g., ethinyl estradiol) when taking pitolisant and for at least 21 days after discontinuation of pitolisant treatment.Women of child-bearing potential must have a negative serum pregnancy test performed at the screening visit.Patients should be free of prohibited treatments or have discontinued them for at least 7 days prior to the start of treatments.Patients with a diagnosis of narcolepsy with or without cataplexy according to the ICSD or DSM criteria at the time of diagnosis.Men or women, 18 years of age and over.
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