Michael J. Thorpy
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View article: Once‐Nightly Sodium Oxybate Meets American Academy of Sleep Medicine Criteria for Treatment of Narcolepsy
Once‐Nightly Sodium Oxybate Meets American Academy of Sleep Medicine Criteria for Treatment of Narcolepsy Open
Data from the REST‐ON trial were not available before the 2021 American Academy of Sleep Medicine (AASM) clinical practice guideline update, which included a literature review through August 2020. This post hoc analysis from REST‐ON assess…
View article: 0834 Hypnagogic/Hypnopompic Hallucination Types Among Participants with Narcolepsy Type 1 from the Phase 3 REST-ON Trial
0834 Hypnagogic/Hypnopompic Hallucination Types Among Participants with Narcolepsy Type 1 from the Phase 3 REST-ON Trial Open
Introduction Limited information is available to quantify hypnagogic/hypnopompic hallucination (HH) events people with narcolepsy (PWN) may experience. This post hoc analysis from the phase 3 REST-ON trial evaluated individual HH types. Me…
View article: 0832 Clinically Meaningful Improvement in Daytime Sleepiness with ON-SXB in People with Narcolepsy and Severe Sleepiness
0832 Clinically Meaningful Improvement in Daytime Sleepiness with ON-SXB in People with Narcolepsy and Severe Sleepiness Open
Introduction Efficacy of once-nightly sodium oxybate (ON-SXB; LUMRYZ™) for narcolepsy was demonstrated in the phase 3 REST-ON trial (NCT02720744). Efficacy on daytime sleepiness in REST-ON participants with the most severe sleepiness at ba…
View article: 0836 Consistent Efficacy of Once-Nightly Sodium Oxybate on Disrupted Nighttime Sleep in People with Narcolepsy
0836 Consistent Efficacy of Once-Nightly Sodium Oxybate on Disrupted Nighttime Sleep in People with Narcolepsy Open
Introduction Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) demonstrated efficacy in treating narcolepsy symptoms, including disrupted nighttime sleep (DNS), in the phase 3 REST-ON trial (NCT02720744). This post hoc analysis assessed ON-SXB…
View article: How once-nightly sodium oxybate is processed in the body in healthy volunteers: a plain language summary
How once-nightly sodium oxybate is processed in the body in healthy volunteers: a plain language summary Open
What is this summary about? This is a plain language summary of an article originally published in the journal Sleep Medicine. Narcolepsy is a sleep condition in which people have periods of extreme sleepiness during the day. People with n…
View article: Social support and isolation in narcolepsy and idiopathic hypersomnia: An international survey
Social support and isolation in narcolepsy and idiopathic hypersomnia: An international survey Open
People with narcolepsy or idiopathic hypersomnia often do not know others living with the same condition, even though this is associated with feeling supported. Clinicians should assess for social support and assist with resource identific…
View article: Efficacy of once-nightly sodium oxybate (FT218) on daytime symptoms in individuals with narcolepsy with or without concomitant alerting agent use: A post hoc analysis from the phase 3 REST-ON trial
Efficacy of once-nightly sodium oxybate (FT218) on daytime symptoms in individuals with narcolepsy with or without concomitant alerting agent use: A post hoc analysis from the phase 3 REST-ON trial Open
Regardless of concomitant alerting agent use, ON-SXB improved daytime and nighttime narcolepsy symptoms vs placebo.
View article: REM sleep in narcolepsy
REM sleep in narcolepsy Open
Narcolepsy is mainly associated with excessive daytime sleepiness, but the characteristic feature is abnormal rapid eye movement (REM) sleep phenomena. REM sleep disturbances can manifest as cataplexy (in narcolepsy type 1), sleep paralysi…
View article: Improvements in daytime sleepiness and disrupted nighttime sleep with once-nightly sodium oxybate in people with narcolepsy type 1 and type 2: a plain language summary
Improvements in daytime sleepiness and disrupted nighttime sleep with once-nightly sodium oxybate in people with narcolepsy type 1 and type 2: a plain language summary Open
What is this summary about? This is a plain language summary of a published article in the journal Sleep . Narcolepsy is a sleep condition that has 2 different subtypes: narcolepsy type 1 and narcolepsy type 2. These are called NT1 and NT2…
View article: Clinical considerations in the treatment of idiopathic hypersomnia
Clinical considerations in the treatment of idiopathic hypersomnia Open
Idiopathic hypersomnia typically is a chronic and potentially debilitating neurologic sleep disorder, and is characterized by excessive daytime sleepiness. In addition to excessive daytime sleepiness, idiopathic hypersomnia symptoms can in…
View article: Improvement in sleep latency with extended-release once-nightly sodium oxybate for the treatment of adults with narcolepsy: Analysis from the phase 3 REST-ON clinical trial
Improvement in sleep latency with extended-release once-nightly sodium oxybate for the treatment of adults with narcolepsy: Analysis from the phase 3 REST-ON clinical trial Open
Significantly more participants who received ON-SXB experienced increased mean sleep latency ≥5 to ≥20 min; at the 2 highest doses, >10 % remained awake for the entirety of the MWT. ON-SXB offers a once-at-bedtime treatment option for adul…
View article: Dosing Optimization of Low-Sodium Oxybate in Narcolepsy and Idiopathic Hypersomnia in Adults: Consensus Recommendations
Dosing Optimization of Low-Sodium Oxybate in Narcolepsy and Idiopathic Hypersomnia in Adults: Consensus Recommendations Open
View article: Cataplexy response with extended-release once-nightly sodium oxybate: Post hoc responder analyses from the phase 3 REST-ON clinical trial
Cataplexy response with extended-release once-nightly sodium oxybate: Post hoc responder analyses from the phase 3 REST-ON clinical trial Open
A significantly greater proportion of participants receiving ON-SXB vs placebo experienced reductions in weekly cataplexy episodes at all tested doses. Approximately 10% of participants taking the 2 highest ON-SXB doses had complete elimin…
View article: Low-Sodium Oxybate Improved Symptoms in Adults with Narcolepsy with Cataplexy: A Plain Language Summary of Publication
Low-Sodium Oxybate Improved Symptoms in Adults with Narcolepsy with Cataplexy: A Plain Language Summary of Publication Open
What is this summary about? This plain language summary describes a clinical study that looked at the effects of a medicine called low-sodium oxybate (or LXB; XYWAV® [calcium, magnesium, potassium, and sodium oxybates]) in adults with narc…
View article: 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
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 Open
View article: Efficacy of once-nightly sodium oxybate (FT218) in narcolepsy type 1 and type 2: post hoc analysis from the Phase 3 REST-ON Trial
Efficacy of once-nightly sodium oxybate (FT218) in narcolepsy type 1 and type 2: post hoc analysis from the Phase 3 REST-ON Trial Open
Study Objectives Post hoc analyses from the phase 3 REST-ON trial evaluated efficacy of extended-release once-nightly sodium oxybate (ON-SXB; FT218) vs placebo for daytime sleepiness and disrupted nighttime sleep in narcolepsy type 1 (NT1)…
View article: Clinician Preferences for Oxybate Treatment for Narcolepsy: Survey and Discrete Choice Experiment
Clinician Preferences for Oxybate Treatment for Narcolepsy: Survey and Discrete Choice Experiment Open
View article: 0585 A four-week randomized, double-blind, placebo-controlled, phase 2 study of mazindol ER in the treatment of narcolepsy
0585 A four-week randomized, double-blind, placebo-controlled, phase 2 study of mazindol ER in the treatment of narcolepsy Open
Introduction Mazindol is the first partial orexin 2 receptor agonist and triple monoamine reuptake inhibitor in development for the treatment of narcolepsy. A novel extended release (ER) formulation was developed to allow once-daily dosing…
View article: 0578 Clinician and Patient Global Impression in a Phase 2 Study of Mazindol (NLS-1021) in Adults with Narcolepsy Type 1 and Type 2
0578 Clinician and Patient Global Impression in a Phase 2 Study of Mazindol (NLS-1021) in Adults with Narcolepsy Type 1 and Type 2 Open
Introduction Mazindol is the first partial orexin 2 receptor agonist and triple monoamine reuptake inhibitor in development for the treatment of narcolepsy. Clinician and Patient Global Impression (CGI and PGI, respectively) for cataplexy …
View article: 0593 Functional Outcomes of Sleep Questionnaire in a phase 2 study of mazindol ER in narcolepsy
0593 Functional Outcomes of Sleep Questionnaire in a phase 2 study of mazindol ER in narcolepsy Open
Introduction Efficacy secondary outcome measure Functional Outcomes of Sleep Questionnaire, Short Version (FOSQ-10] was collected in the Phase 2 (POLARIS, NLS-1021), multicenter (n=21) study of mazindol ER in adult participants with narcol…
View article: 0595 Long-term efficacy on cataplexy attacks and excessive daytime sleepiness in open-label extension study (NLS-1022) of mazindol ER
0595 Long-term efficacy on cataplexy attacks and excessive daytime sleepiness in open-label extension study (NLS-1022) of mazindol ER Open
Introduction Mazindol ER (extended-release), the first partial orexin-2 receptor agonist and triple mono-aminergic reuptake inhibitor, has demonstrated efficacy and safety in significantly reducing excessive daytime sleepiness (EDS) and ca…
View article: 0592 Efficacy of Lower-Sodium Oxybate by Baseline Sleep Inertia in a Phase 3 Clinical Study in Patients With Idiopathic Hypersomnia
0592 Efficacy of Lower-Sodium Oxybate by Baseline Sleep Inertia in a Phase 3 Clinical Study in Patients With Idiopathic Hypersomnia Open
Introduction Idiopathic hypersomnia is a debilitating neurologic sleep disorder. Sleep inertia (difficulty awakening) is a common symptom that can significantly impair functioning and quality of life. This post hoc analysis evaluated respo…
View article: Long-Term Safety and Tolerability During a Clinical Trial and Open-Label Extension of Low-Sodium Oxybate in Participants with Narcolepsy with Cataplexy
Long-Term Safety and Tolerability During a Clinical Trial and Open-Label Extension of Low-Sodium Oxybate in Participants with Narcolepsy with Cataplexy Open
ClinicalTrials.gov identifier NCT03030599 (25 January 2017).
View article: Clinical considerations for the diagnosis of idiopathic hypersomnia
Clinical considerations for the diagnosis of idiopathic hypersomnia Open
Idiopathic hypersomnia is a sleep disorder of neurologic origin characterized by excessive daytime sleepiness, with sleep inertia, long, unrefreshing naps, and prolonged nighttime sleep being key symptoms in many patients. Idiopathic hyper…
View article: Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia
Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia Open
During open-label treatment with LXB, participants showed clinically meaningful improvements in idiopathic hypersomnia symptoms and in quality of life and functional measures. TEAE incidence declined over LXB titration and optimization.
View article: Randomized, crossover, open-label study of the relative bioavailability and safety of FT218, a once-nightly sodium oxybate formulation: Phase 1 study in healthy volunteers
Randomized, crossover, open-label study of the relative bioavailability and safety of FT218, a once-nightly sodium oxybate formulation: Phase 1 study in healthy volunteers Open
GHB exposure and Cmax with one 6-g dose of ON-SXB were bioequivalent to those with two 3-g doses of twice-nightly SXB, whereas C8h was lower with ON-SXB. If approved, ON-SXB will provide a single bedtime oxybate optio…
View article: Solriamfetol Titration and AdministRaTion (START) in Patients with Obstructive Sleep Apnea: A Retrospective Chart Review and Hypothetical Patient Scenario
Solriamfetol Titration and AdministRaTion (START) in Patients with Obstructive Sleep Apnea: A Retrospective Chart Review and Hypothetical Patient Scenario Open
View article: Correction to: Changes in Cataplexy Frequency in a Clinical Trial of Lower‑Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications
Correction to: Changes in Cataplexy Frequency in a Clinical Trial of Lower‑Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications Open
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View article: Changes in Cataplexy Frequency in a Clinical Trial of Lower-Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications
Changes in Cataplexy Frequency in a Clinical Trial of Lower-Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications Open
View article: 0386 Long-term Safety During a Clinical Trial of Lower-Sodium Oxybate in Participants With Narcolepsy With Cataplexy
0386 Long-term Safety During a Clinical Trial of Lower-Sodium Oxybate in Participants With Narcolepsy With Cataplexy Open
Introduction Treatment-emergent adverse events (TEAEs) were analyzed during a 6-month open-label extension (OLE) of a double-blind, placebo-controlled, randomized withdrawal trial (NCT03030599) of lower-sodium oxybate (LXB; Xywav™). LXB is…