The NeurologyLive® Narcolepsy Disease Spotlight page offers specific updates and coverage on the latest expert conversations and data readouts related to the treatment and management of patients with the sleep disorder.
Evaluating Positive Phase 1 Trial Data for Narcolepsy Agent ALKS 2680
Brendon Yee, PhD, a respiratory and sleep physician at the Woolcock Institute of Medical Research, discussed findings from a recent phase 1 trial presented at World Sleep Congress 2023 in which ALKS 2680 demonstrated improvements in wakefulness among patients with narcolepsy type 1.
Orexin Receptor ALKS 2680 Demonstrates Positive Phase 1 Findings
Preliminary data from a phase 1 study suggest that ALKS 2680, an investigational orexin 2 receptor agonist, is safe and improves sleep latency in narcolepsy patients, leading to plans for a phase 2 study.
FDA Clears Neurovalens’ Modius Sleep Device for Insomnia
Modius Sleep is designed to send a safe electrical pulse into the vestibular nerve, influencing the areas of the hypothalamus and brain stem that control circadian rhythm and sleep patterns.
NeurologyLive® Brain Games: November 5, 2023
Test your neurology knowledge with NeurologyLive®'s weekly quiz series, featuring questions on a variety of clinical and historical neurology topics. This week's topic is narcolepsy.
Preclinical Data Shows Significant Efficacy With Low-Dose of ORX750 for Narcolepsy
Presented at the 2023 World Sleep Congress, preclinical findings highlighted ORX750's potential as a novel treatment not only for narcolepsy type 1 but also for broader sleep-wake disorders, including narcolepsy type 2 and idiopathic hypersomnia.
Takeda’s TAK-861 Shows Promise in Improving Wakefulness in Phase 1 Trial Among Healthy Men
A recent study assessing TAK-861, an orexin-type 2 receptor agonist, high and lose doses of the therapy demonstrated improvements in wakefulness compared with the placebo in healthy adult men.
Updates in the Management of Excessive Daytime Sleepiness and Narcolepsy
A group of sleep experts discuss the importance of timely and accurate diagnosis, recent approvals, and available treatment options for managing a chronic disorder and its symptoms.
Addressing Unmet Needs of Narcolepsy Beyond Medication
Nancy Foldvary-Schaefer, DO, FAAN, director of the Sleep Disorders Center and staff in the Epilepsy Center at Cleveland Clinic, discussed the recent advancements in narcolepsy treatments and the importance of incorporating a holistic care approach for patients.
Despite Missing Primary End Point, Pitolisant Shows Positive Outcomes in Phase 3 INTUNE Trial for Idiopathic Hypersomnia
During the open-label treatment period, 83% of patients with idiopathic hypersomnia who completed treatment saw a significant reduction in sleepiness, with an average Epworth Sleepiness Scale change of -9.4 points.
The Significance of Normal Mean Sleep Latency in Diagnosing Narcolepsy
Mark I. Boulos, MD, BSc, FRCP, CSCN, MSc, associate professor of medicine, division of neurology, Institute of Medical Science, University of Toronto, talked about a comprehensive meta-analysis aimed to determine normal mean sleep latency values to accurately help clinicians with interpreting sleep test results.
Key Insights into Multiple Sleep Latency Test Norms Using Large-Scale Data: Mark I. Boulos, MD, BSc, FRCP, CSCN, MSc
The associate professor, department of medicine, division of neurology, Institute of Medical Science, University of Toronto, talked about the importance of establishing normal values for sleep studies, particularly the multiple sleep latency test, to help with effectively diagnosing sleep disorders. [WATCH TIME: 5 minutes]
Role of Sleep Coaching, Sleep Reset in the Care of Sleep Problems
Michael Grandner, PhD, associate professor of psychiatry at the University of Arizona College of Medicine, discussed Sleep Reset, an app-based, personalized sleep program that uses sleep coaches to help guide patients in the care of their sleep disorders.
Novel Insights on Orexin Receptor TAK-994 and its Discontinued Narcolepsy Study
Elena Koundourakis, PhD, head of orexin franchise development at Takeda, talked about the phase 2 trial investigating TAK-994 in patients with narcolepsy type 1, which showed significant improvements in wakefulness, despite discontinuation because of hepatotoxicity.
Axsome Therapeutics Postpones Data Readout for Phase 3 SYMPHONY Trial
The phase 3 SYMPHONY trial assessing AXS-12, a selective norepinephrine reuptake inhibitor for narcolepsy, was initially expected in the third quarter of 2023.
World Narcolepsy Day 2023: Latest Literature of Therapeutic Progress
On World Narcolepsy Day 2023, get a recap of the latest advances in narcolepsy that you might have missed over the last few months, compiled all into one place by the NeurologyLive team.
Episode 98: Uncovering Phenotypical Features of Narcolepsy Type 1
Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Birgitte Kornum, MD. [LISTEN TIME: 18 minutes]
Narcolepsy Potentially Identified as a Symptom of Immediate Food Allergic Reactions in Pediatrics
In a large cohort of 848 pediatric participants with challenge-proven food allergy, investigators identified narcolepsy-like sleepiness as a symptom impacting more than 1 in 10 patients with food allergies.
Lack of Sex Differences and High Frequency of Neurological Abnormalities Identified in REM Sleep Behavior Disorder
In a recent multisite analysis of 361 patients with REM sleep behavior disorder, 84% had neurological abnormalities in at least one domain observed.
Long-Term Safety and Tolerability of Low-Sodium Oxybate Confirmed
In a recent long-term analysis of a phase 3 trial, the most common treatment-emergent adverse events that led to discontinuation of low-sodium oxybate were cataplexy, headache, nausea, and psychiatric disorders.
Nocturnal Sodium Oxybate Treatment Functional Network Changes Associated With Anterior Cingulate GABA
Sodium oxybate, an endogenous GHB/GABAB receptor agonist, is clinically used to promote slow-wave sleep and reduce next-day sleepiness in disorders such as for patients with narcolepsy
Ulotaront Fails to Differentiate From Placebo in Phase 1b Crossover Trial for Narcolepsy-Cataplexy
Acute and sustained treatment with ulotaront did not show a statistically significant decrease from placebo in total number of cataplexy events and had no significant change in other symptomatic ratings over a 2-week treatment period.
Opioids Improve Disturbed Nocturnal Sleep and Excessive Daytime Sleepiness in Narcolepsy Type 1
In a recent study on patients with narcolepsy type 1, those who used opioid drugs such as oxycodone and codeine were significantly associated with improved self-reported narcolepsy symptom severity.
Longer Sleep Latency Time Observed With Recent Definition of Sleep Onset, Meta-Analysis Shows
A recent systematic review and meta-analysis showed that normal mean sleep latency in adults was 11.7 minutes using the earlier definition of sleep onset and 11.8 minutes using the later definition of sleep onset.
Despite Positive Efficacy, Safety Concerns Halt Phase 2 Trial of Orexin Receptor TAK-994 in Narcolepsy Type 1
The phase 2 trial represented the first-ever clinical data to be published of an oral orexin agonist for patients living with narcolepsy type 1.
Significantly Larger Hypothalamic Volume in Narcolepsy Type 1 Following H1N1 Infection
Prior research shows that a significant loss of the hypocretin-producing neurons, an increase in the histaminergic neurons, and contradicting signs of gliosis in the hypothalamus among patients with narcolepsy type 1.
NeurologyLive® Brain Games: August 6, 2023
Test your neurology knowledge with NeurologyLive®'s weekly quiz series, featuring questions on a variety of clinical and historical neurology topics. This week's topic is sleep disorders.
Increased New-Onset Cardiovascular Risk Observed in Narcolepsy
The findings confirmed and expanded upon existing literature by demonstrating that the incidence rates of multiple cardiovascular events, including stroke, heart failure, and cardiovascular disease, are significantly higher in patients with narcolepsy.
Rare Case Study Challenges Hypocretin-1 Thresholds for Narcolepsy Diagnosis
A 26-year-old man who presented narcolepsy symptoms tested negative for the condition, but a reassessment of the cerebrospinal fluid hypocretin-1 4 years later showed a dramatic decrease.
Cognitive Sleep Coaching Program Improves Sleep Duration and Quality
Completion of the 12-week program was associated with reported improvements in overall changes in sleep parameters of sleep latency, wake after sleep onset, sleep efficiency, and others.
Episode 91: Assessing the Landscape of Sleep Disorder Care
Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Ann Marie Morse, DO, FAAN. [LISTEN TIME: 20 minutes]
Clinical Improvements in Cataplexy Seen Through Mazindol Extended-Release Treatment
In a secondary analysis of a double-blind trial, mazindol extended-release outperformed placebo on clinician and patient scales of cataplexy severity and excessive daytime sleepiness.
How Once-Nightly Sodium Oxybate Changes the Treatment Landscape for Narcolepsy
John Harsh, PhD, clinical research director, Colorado Sleep Institute, sat down at SLEEP 2023 to discuss the RESTORE study results, and why patients with narcolepsy appear to prefer once-nightly sodium oxybate.
RESTORE Analysis Shows Significant Patient Preference to Once-Nightly Sodium Oxybate Over Twice-Nightly
Patients on twice-nightly oxybate reported more issues with inconvenience, anxiety, and feeling somewhat, quite a bit, or extremely groggy/unsteady the next morning.
Samelisant Shows Potential as a Treatment for Excessive Daytime Sleepiness in Parkinson Disease
Preclinical findings show the potential of samelisant, a potent and orally active Histamine H3 receptor inverse agonist, as a potential treatment for patients with Parkinson disease who experience excessive daytime sleepiness.
NeuroVoices: Kumar Budur, MD, on Pitolisant’s Impact in Excessive Daytime Sleepiness, Prader-Willi Syndrome
The chief medical officer of Harmony Biosciences provided perspective on a proof-of-concept study assessing pitolisant’s (Wakix) clinical benefit in reducing excessive daytime sleepiness individuals with Prader-Willi syndrome.
Need for Additional Treatments to Target Secondary Symptoms of Narcolepsy: Anne Marie Morse, DO, FAASM
The pediatric neurologist and sleep medicine specialist at Geisinger Medical Center provided commentary on the current unmet needs for patients with narcolepsy, including improvements in treatment options. [WATCH TIME: 3 minutes]
Low-Sodium Oxybate Remains Efficacious Regardless of Baseline Sleep Inertia
Nearly all patients showed improvement on the Patient Global Impression of Change scale, regardless of sleep inertia status, assessed through a visual analog scale.
Once-Nightly Sodium Oxybate Shows Significant Impact on Cataplexy Attacks, Post-Hoc Analysis Shows
Following 13 weeks of treatment with once-nightly sodium oxybate, some patients in the 7.5 g and 9.0 g groups showed complete resolution of cataplexy attacks.
Improving Awareness of Sleep-Heart Associations and the Precursor Signs to Heart Issues: Richard Bogan, MD, FCCP, FAASM
The medical director of SleepMed in South Carolina discussed the need for more overall awareness of poor sleep and the risk factors associated with worsened heart health. [WATCH TIME: 3 minutes]
Enrollment for Phase 3 INTUNE Study of Pitolisant in Idiopathic Hypersomnia Ahead of Schedule
Pitolisant, a therapy approved for patients with narcolepsy, is currently being assessed in 200 individuals with idiopathic hypersomnia, with change in excessive daytime sleepiness as the primary outcome.
REM Sleep Duration Shows Potential as Neurophysiological Biomarker for Diagnosing Hypocretin-Deficient Narcolepsy
Alternative multiple sleep latency test parameters was found to be a better identification method for recognizing hypocretin-deficiency among patients with hypersomnolence and narcolepsy.
Insulin Resistance Associated With Metabolic Disturbances in Pediatric Narcolepsy
Findings showed that pediatric patients with narcolepsy who have had at least 2 components of metabolic syndrome may be at higher risk of future complications.
Improvements in Knowledge of Sleep and Heart Health: Richard Bogan, MD, FCCP, FAASM
The medical director of SleepMed in South Carolina provided perspective on the importance of understanding the link between sleep disorders, poor sleep, and heart health. [2 minutes]
FDA Approves Once-Nightly Formulation of Sodium Oxybate to Treat Narcolepsy
Although it has the same ingredients as previously approved Xyrem, extended-release sodium oxybate is a medication taken once-nightly instead of twice-nightly.
Expanding KP1077’s Clinical Program to Address Narcolepsy and Other Conditions: Christal Mickle
The cofounder and chief product development officer of Zevra Therapeutics talked about the phase 1 clinical trial of KP1077 for narcolepsy and potentially using it to treat other conditions. [WATCH TIME: 5 minutes]
Reduced Levels of Resilience Reported in Patients With Narcolepsy Type 1
Resilience was positively correlated with quality of life in patients with narcolepsy type 1, according to a recent published study.
Narcolepsy Incidence Increase During H1N1 Pandemic Period Not Driven by Pandemrix Vaccine, Chinese Report Suggests
Incidence of narcolepsy increased 4.17- and 1.42-fold during and after the 2009 H1N1 pandemic when compared with baseline.
Increased Risk of Human Leukocyte Antigen Related Autoimmune Diseases in Narcolepsy
Evidence from a nationwide healthcare system data in South Korea showed that narcolepsy is closely related to systemic autoimmune diseases, particularly those related to HLA genes.
Phase 3 Trial Enrollment, Topline Data Expected Earlier for Pitolisant in Idiopathic Hypersomnia
Pitolisant will be assessed in 200 patients with idiopathic hypersomnia, using change in excessive daytime sleepiness as the primary end point.
EMA Approves Pitolisant for Pediatric Narcolepsy
Pitolisant, marketed as Wakix, recently received approval from the European Medicines Agency for pediatric narcolepsy with or without cataplexy.
Mazindol Extended Release Agent Demonstrates Significant Efficacy in Open-Label Extension in Narcolepsy
Over a 6-month open-label extension period, mazindol ER was found to be safe, with patients demonstrating significant decreases in number of weekly cataplexy episodes and improvements in daytime sleepiness.
Pitolisant Improves Pediatric Narcolepsy Symptoms Regardless of Cataplexy in Phase 3 Study
Pitolisant, a selective histamine H3 receptor inverse agonist, reduced the frequency of cataplexy in pediatric patients with narcolepsy.
Avadel Pharmaceuticals Urges FDA to Make Decision on Extended-Release Formulation of Sodium Oxybate
In a phase 3 study, extended-release sodium oxybate demonstrated statistically significant and clinically meaningful results in excessive daytime sleepiness, clinician’s assessment of patient’s functioning, and reduction in cataplexy attacks.
Sodium Oxybate Demonstrates Long-term Safety and Maintained Efficacy in Pediatric Narcolepsy with Cataplexy
An evaluation on the long-term treatment profile of sodium oxybate on pediatrics with narcolepsy revealed a safety profile similar to previous adult studies and identified no unexpected safety concerns.
Improvements to the Detection, Psychosocial Aspects of Narcolepsy in Adolescents: Eric Zhou, PhD
The assistant professor of pediatrics at Harvard Medical School provided perspective on the care needs of adolescents and young adults with narcolepsy, and the importance of early detection of lingering issues. [WATCH TIME: 3 minutes]
Depression History Shows No Impact on Efficacy, Safety of Solriamfetol in Treating Obstructive Sleep Apnea, Narcolepsy
Results of solriamfetol were similar when outcomes were examined in subgroups of concomitant antidepressant use, regardless of depression history, indicating that antidepressants did not affect the efficacy of the drug.
Episode 85: Impact of Narcolepsy on Social Relationship Health in Adolescents
Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Eric Zhou. [LISTEN TIME: 14 minutes]
A Balancing Challenge: Social Relationships in the Life of Adolescents With Narcolepsy
Anne Marie Morse, DO, a pediatric neurologist and sleep medicine specialist at Geisinger Medical Center, talked about the challenges that adolescents with narcolepsy face in their social relationships.
Neuro News Roundup: World Sleep Day 2023
In honor of World Sleep Day, held March 17, 2023, get caught up on some of the latest news in sleep disorders as the NeurologyLive® team shares some of our data updates.
Clinical and Neuropsychological Data on Narcolepsy Shows No Difference in Comparison of Global Networks
A comparison of narcolepsy cases from the Russian Narcolepsy Network did not differ from data in the European Narcolepsy Network.
Narcolepsy Causes Significant Impact on Social Relationship Health in Adolescents, Study Shows
Published findings showed that narcolepsy has a significant impact on social relationships in adolescents, thus suggesting that structured routine for assessing social health is a vital first step for treatment.
Titration Common in Solriamfetol, Leads to Improvements in Daytime Sleepiness
Epworth Sleepiness Scale scores improved by an average of 4.3 points overall, with more than 90% of patients reporting perceived improvements in their excessive daytime sleepiness.
Changes in Sleep Architecture, Comorbidities Observed in Long-Term Treatment With Sodium Oxybate
At 1 and 3 years follow-up, sodium oxybate-treated patients showed significant increases in periodic leg movements index and significantly higher apnea-hypopnea index.
Although Frequently Used, Complementary and Alternative Medicine Ineffective to Treat Narcolepsy
Frequent medication change, adverse events, and low medication adherence appears more frequently in patients with narcolepsy who use complementary and alternative medicine.
Driving Performance in Patients With Narcolepsy Improved Through Solriamfetol
Findings indicated that the robust wake-promoting efficacy of solriamfetol demonstrated in clinical trials resulted in improved real-world functional performance in participants with narcolepsy.
Pitolisant Shows Effectiveness as Treatment for Pediatric Narcolepsy
Data showed improvement in excessive daytime sleepiness and cataplexy frequency for children with narcolepsy on pitolisant.
The Science of Sleep Health and Romantic Relationships: Wendy Troxel, PhD
For Valentine’s Day, the senior behavioral scientist at the RAND Corporation talked about the significance of sleep health and romantic relationships [WATCH TIME: 5 minutes]
Polysomnography More Commonly Used in Narcolepsy Detection Prior to Multiple Sleep Latency Test
A web-based survey of Korean neurologists interested in narcolepsy presented their concerns with using the multiple sleep latency test, noting that it may lead to ambiguous results due to accompanying sleep disorders like sleep apnea.
Case Study and Overview of WAKIX® (pitolisant) Tablets in the Treatment of Excessive Daytime Sleepiness and/or Cataplexy in Adults with Narcolepsy
Alterations in Gylmphatic Activity Not Significant in Different Narcolepsy Types, Correlated With PSG Parameters
Glymphatic function demonstrated no significant difference in patients with type 1 and type 2 narcolepsy in comparison with healthy controls.
Adolescents and Parents Prefer Receiving Medical Information at Diagnosis of Narcolepsy
A questionnaire showed that adolescents with narcolepsy and parents prefer to receive details on narcolepsy at the time of diagnosis from a healthcare provider.
Clinician-Based Survey Highlights Challenges in Diagnosing Narcolepsy in Children, Adolescents
When asked which efficacious diagnostic or treatment options they hope to see in the future, a majority of physicians, especially specialists, expressed a desire to see more useful biomarkers, followed by more effective diagnostic tests overall.
Improvements in Treating Narcolepsy, Idiopathic Hypersomnia Through Xywav
Richard Bogan, MD, FCCP, FAASM, associate clinical professor, University of South Carolina School of Medicine, provided commentary on multifunctional capabilities of Xywav and how the medication has improved care for narcolepsy and idiopathic hypersomnia.
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