Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy

Abstract Study Objectives To assess the efficacy and safety of FT218, a novel once-nightly formulation of sodium oxybate (ON-SXB), in patients with narcolepsy in the phase 3 REST-ON trial. Methods Narcolepsy patients aged ≥16 years were randomized 1:1 to uptitration of ON-SXB (4.5, 6, 7.5, and 9 g)...

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Veröffentlicht in:	Sleep (New York, N.Y.) N.Y.), 2022-06, Vol.45 (6), p.1
Hauptverfasser:	Kushida, Clete A, Shapiro, Colin M, Roth, Thomas, Thorpy, Michael J, Corser, Bruce C, Ajayi, Akinyemi O, Rosenberg, Russell, Roy, Asim, Seiden, David, Dubow, Jordan, Dauvilliers, Yves
Format:	Artikel
Sprache:	eng
Schlagworte:	Armodafinil Cataplexy - drug therapy Chronic illnesses Clinical trials Complications and side effects Disease Double-Blind Method Drug dosages Editor's Choice Gamma-hydroxybutyrate Hospitalization Humans Life Sciences Narcolepsy Narcolepsy - drug therapy Neurological Disorders Neurology Neurons and Cognition Patient compliance Patients Pharmaceutical sciences Pharmacokinetics Pharmacology Sleep disorders Sleepiness Sodium Sodium Oxybate - adverse effects Treatment Outcome Type 2 diabetes Wakefulness
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