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Journal: Effects of sodium oxybate on hypocretin/orexin and locus coeruleus neurons. (Pubmed Central) - May 8, 2023 Therefore despite some similar effects on narcoleptic symptomatology, SXB does not produce anatomical changes similar to those elicited by opiates. Analysis of changes in other links in the cataplexy pathway might further illuminate SXB's mechanism of action on narcolepsy.
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Journal: Calcium, Magnesium, Potassium and Sodium Oxybates (Xywav) in Sleep Disorders: A Profile of Its Use. (Pubmed Central) - May 18, 2022 Furthermore, worsening in patient- and clinical-rated global scales, as well as measures of health-related quality of life were also seen with placebo versus lower-sodium oxybate. Lower-sodium oxybate is generally well tolerated, with the tolerability profile being largely consistent to that seen with sodium oxybate.
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Long-Term Effects of Lower-Sodium Oxybate on Functioning and Work Productivity in Participants With Idiopathic Hypersomnia ([VIRTUAL]) - Mar 29, 2022 - Abstract #AAN2022AAN_4058; LXB is a new oxybate treatment with 92% less sodium than sodium oxybate (Xyrem®)...ObjectivetttttttttTo report the long-term effects of lower-sodium oxybate (LXB; Xywav®) on functioning and work productivity in a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia (IH)...ConclusionstttttttttSustained efficacy on functioning (FOSQ-10) and work productivity (WPAI:SHP) in adults with IH was maintained throughout the open-label extension period. The overall safety profile was consistent with that of LXB in narcolepsy.
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Trial completion, Real-world evidence, Real-world: A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy (clinicaltrials.gov) - Mar 10, 2022 P=N/A, N=110, Completed, Our preliminary data, requiring extension, suggest that a 3g sedative SO dose might cause slight transient inhibition of dopamine release in limbic striatum. Active, not recruiting --> Completed
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New narcolepsy-ataxia and neuropathy phenotype not associated with DNMT1 (Concourse / Mezzanine) - Feb 26, 2022 - Abstract #WSS2022WSS_1065; A late onset case of narcolepsy, ataxia and peripheral neuropathy -not sensitive- and without deafness not linked to any genetic described mutation is shown. Due to the clinical similarities with the pictures associated with DNMT1 mutations, the case indicates that some phenotype of the so-called DNMT1- complex disorder might not always be related with the targeting sequence domain of DNMT1.
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Journal: Xywav - a mixed-salt oxybate oral solution for idiopathic hypersomnia. (Pubmed Central) - Feb 8, 2022 Due to the clinical similarities with the pictures associated with DNMT1 mutations, the case indicates that some phenotype of the so-called DNMT1- complex disorder might not always be related with the targeting sequence domain of DNMT1. No abstract available
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Enrollment closed, Enrollment change, Real-world evidence, Real-world: A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy (clinicaltrials.gov) - Oct 7, 2021 P=N/A, N=111, Active, not recruiting, In study participants with IH, LXB demon strated improvement in measures of functioning and work productivity. Recruiting --> Active, not recruiting | N=350 --> 111
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KEY-10 - Brave New World: Guidelines and Treatment Strategies for Sickle Cell Disease (Castellana 1 / L3) - Sep 15, 2021 - Abstract #PAINWeek2021PAINWeek_223; This course evaluates those recommendations for acute pain management of VOC and uses a case based approach to discuss a sensible and balanced strategy for pain and symptom management. Learning Objectives: Summarize the healthcare disparities in accessing care for patients with sickle cell disease (SCD) Describe strategies to effectively manage acute and chronic pain in patients with SCD Review the recently published guidelines for SCD treatment and management Discuss the newly FDA-approved and emerging treatments for adult and pediatric patients with SCD Recognize effective communication techniques when diagnosing, treating, and managing patients with SCD
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Enrollment open: An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy (clinicaltrials.gov) - Mar 24, 2021 P4, N=100, Recruiting, The supra–dose proportionality of LXB observed in participants with IH is consistent with results from other studies of LXB and SXB. Not yet recruiting --> Recruiting
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Journal: Pitolisant (Wakix) for narcolepsy. (Pubmed Central) - Mar 10, 2021 Participants not previously taking SXB achieved an individually optimized dose of LXB after a median of 3 adjustments. No abstract available
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Enrollment change, Trial completion date, Trial withdrawal: Evaluation of the Efficacy of Sodium Oxybate (Xyrem (clinicaltrials.gov) - Mar 4, 2021 P1, N=0, Withdrawn, No abstract available N=20 --> 0 | Trial completion date: Dec 2020 --> Sep 2020 | Recruiting --> Withdrawn
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