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Long-term efficacy and safety of low-sodium oxybate in an open-label extension period of a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia [PDF]

Journal of Clinical Sleep Medicine, 2023
To evaluate 6-month efficacy and safety of low-sodium oxybate in people with idiopathic hypersomnia during an open-label extension period (OLE) of a phase 3 clinical trial.Efficacy measures included the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS), Patient Global Impression of Change (PGIc), Functional Outcomes of Sleep ...
Anne Marie, Morse, Yves, Dauvilliers, Isabelle, Arnulf, Michael J, Thorpy, Nancy, Foldvary-Schaefer, Patricia, Chandler, Abby, Chen, Luke, Hickey, Jed, Black, Richard K, Bogan   +9 more
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Current knowledge on the pathophysiology of idiopathic hypersomnia and potential mechanisms of action for low-sodium oxybate treatment

Journal of Clinical Sleep Medicine
We sought to elucidate hypotheses for the pathophysiology of idiopathic hypersomnia and discuss the mechanisms by which low-sodium oxybate (LXB) improves idiopathic hypersomnia symptoms.Published literature on idiopathic hypersomnia sleep abnormalities, symptoms, treatments, and underlying pathophysiology was reviewed.Patients with idiopathic ...
Logan D, Schneider, Alyssa, Cairns, Chad, Ruoff, Richard K, Bogan   +3 more
openaire   +3 more sources

0862 Sleep Architecture with Low-Sodium Oxybate Treatment in Narcolepsy: Results from the DUET Study

SLEEP
Abstract Introduction Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) is a phase 4, prospective, multicenter, single-arm, multiple-cohort, open-label study (NCT05875974) evaluating effectiveness of low-sodium oxybate (LXB, Xywav®) treatment on outcomes ...
Chad Ruoff, Logan Schneider, R Sangal, Deborah Nichols, Teresa Steininger, Douglas Fuller, M Kirby, Jessica Alexander, Emmanuel Mignot   +8 more
openaire   +2 more sources

0831 Effectiveness and Safety of Low-Sodium Oxybate in Participants with Narcolepsy: Results from the DUET Study

SLEEP
Abstract Introduction Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) is a phase 4, prospective, multicenter, single-arm, multiple-cohort, open-label study (NCT05875974) assessing the effectiveness of low-sodium oxybate (LXB; Xywav®) treatment on daytime and ...
Logan Schneider, Chad Ruoff, David Plante, Deborah Nichols, Teresa Steininger, Douglas Fuller, M Kirby, Sarah Akerman, Jessica Alexander, Marisa Whalen, Alyssa Cairns   +10 more
openaire   +2 more sources

0647 Efficacy of Low-Sodium Oxybate in Narcolepsy Patients with and Without Cardiovascular or Cardiometabolic Disorders

SLEEP
Abstract Introduction Low-sodium oxybate (LXB; Xywav®) is approved by the US Food and Drug Administration to treat excessive daytime sleepiness or cataplexy in patients ≥7 years of age with narcolepsy, and idiopathic hypersomnia in adults.
Bruce Corser, Shawn Candler, Wayne Macfadden, Douglas Fuller, Thomas Measey, Richard Bogan   +5 more
openaire   +2 more sources

0851 Effectiveness and Safety of Low-Sodium Oxybate in Idiopathic Hypersomnia Participants: Results from the DUET Study

SLEEP
Abstract Introduction Introduction: Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) is a phase 4, prospective, multicenter, single-arm, multiple-cohort, open-label study (NCT05875974) evaluating the effectiveness of low-sodium oxybate (LXB, Xywav®) treatment on
David Plante, Alyssa Cairns, Logan Schneider, Deborah Nichols, Teresa Steininger, Douglas Fuller, M Kirby, Sarah Akerman, Jessica Alexander, Marisa Whalen, Chad Ruoff   +10 more
openaire   +2 more sources

0853 Sleep Architecture with Low-Sodium Oxybate Treatment in Idiopathic Hypersomnia: Results from the DUET Study

SLEEP
Abstract Introduction Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) is a phase 4, prospective, multicenter, single-arm, multiple-cohort, open-label study (NCT05875974) evaluating the effectiveness of low-sodium oxybate (LXB, Xywav®) treatment on outcomes ...
Alyssa Cairns, Richard Bogan, Nancy Foldvary-Schaefer, Deborah Nichols, Teresa Steininger, Douglas Fuller, Sarah Akerman, Jessica Alexander, David Plante   +8 more
openaire   +2 more sources

0856 Real-World Patient Insights on Low-Sodium Oxybate for Idiopathic Hypersomnia: Interim Results from LYRICAL

SLEEP
Abstract Introduction Low-sodium oxybate (LXB; Xywav®) is approved by the US Food and Drug Administration to treat excessive daytime sleepiness or cataplexy in patients ≥7 years of age with narcolepsy and adults with idiopathic hypersomnia (IH).
Caroleen Drachenberg, Jennifer Cline, Jennifer D’Souza, Christina Graham, Emily Kim, Meaghan Lawrence, Meagan Farrell, Grecia Sanchez, Donald Stull, Marisa Whalen, Jessica Alexander, Laura Herpel   +11 more
openaire   +2 more sources