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Articles

The committee all agreed that tofersen presents a favorable risk-benefit profile in this particularly challenging patient population. 

FDA AdComm on Tofersen Supports NfL as Surrogate End Point of Clinical Benefit, But Is It Enough for Approval?

After results indicated significant slowing of ALS disease progression, Coya noted it plans to file an IND with the FDA in the second half of 2023 for a potential clinical study thereafter.

Treg Suppressing Agent COYA 302 Shows Slowing of ALS Disease Progression

If approved, ABBV-951 will become the first subcutaneous delivery of carbidopa/levodopa, often considered the standard of care for symptom management for patients with Parkinson disease.

FDA Issues Complete Response Letter for AbbVie’s 24-Hour Continuous Carbidopa/Levodopa Pump

The professor of neurology and pediatrics at University of Rochester Medical Center shared her thoughts on the 2023 MDA Clinical and Scientific Conference, and the progress made in the treatment of neuromuscular disorders. 

NeuroVoices: Emma Ciafaloni, MD, on Mounting Progress in the Neuromuscular Field, Duchenne Muscular Dystrophy

The neurologist and migraine expert from NYU Langone Health.

Videos

The neurologist and migraine expert from NYU Langone Health shared her reactions to the recently approved zavegepant nasal spray (Zavzpret; Pfizer) for the treatment of migraine. [WATCH TIME: 5 minutes]  

Newly Approved Migraine Nasal Spray Offers Alternative Treatment to Injections, Oral Medications: Shae Datta, MD

Slideshows

Here's the latest multidisciplinary MS research published online first in the International Journal of MS Care.

IJMSC Online First: March 2023

Director, Comprehensive Epilepsy Center, NYU Langone Health

The director of the Comprehensive Epilepsy Center at NYU Langone discussed the importance of healthy eating habits and whether all individuals with epilepsy should consider dieting early in their life. [WATCH TIME: 4 minutes]

Importance of Establishing Healthy Eating Habits in Epilepsy: Orrin Devinsky, MD

The vascular neurologist at Cleveland Clinic provided an overview of a study that assessed the extent HbA1c impacts the relationship between mechanical thrombectomy and poor outcomes. [WATCH TIME: 3 minutes]

Effect of HbA1c Elevation, Glycemic Control Following Mechanical Thrombectomy: David Baker, DO

The epilepsy condition center is a comprehensive resource for clinical news on the diagnosis, treatment, and management of epilepsy.  NeurologyLive.


Epilepsy | Clinical Neurology News & Insights | NeurologyLive

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Clinical

 epilepsy clinical focus page provides information, podcasts, videos, and news about the latest FDA actions, clinical guideline updates, study and clinical trial findings, and interviews with physicians related to epilepsy and related epileptic conditions, including Lennox-Gastaut syndrome, Dravet syndrome, tuberous sclerosis complex, focal seizures, nonmotor seizures, and more.

's featured content in the carousel below.

 to subscribe on your favorite streaming service.

 podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis, Parkinson disease, dementia, sleep disorders, and more.

Episode 82, "Managing Seizures After Ischemic Stroke," features an exclusive interview with Carolina Ferreira Atuesta, MD, MSc, a scientific researcher and clinical data manager at the Icahn School of Medicine at Mount Sinai. She spoke about research she and colleagues recently presented at the 

 on poststroke epilepsy, the ongoing clinical efforts to manage seizures occurring after stroke, what studies still need to explore, and more.

, a streaming channel from MJH Life Sciences

. Check out new content and shows every day, only at

The stories featured in this week's Neurology News Minute, which will give you quick updates on the following developments in neurology, are further detailed here:

FDA Accepts New Drug Application for Duchenne Therapy Vamorolone

Enrollment for Pivotal Phase 3 PHOENIX Study of AMX0035 Completed

Alzheimer’s Association Panel Offers Considerations for New Definition of Meaningful Change in Drug Trials

Sanofi Discontinues Phase 3 Study of Tolebrutinib in Myasthenia Gravis

 – Goals of the study and main findings

 – The understanding of this association in clinical care

 – Current state of prognostication post stroke

 – The lack of standardized approach to monitoring

 podcast. Be sure to leave a rating and review for the show. Thanks for listening!

Hoping to listen on your favorite podcast app? See below:

REFERENCES
1. Atuesta FC. Seizures After Ischemic Stroke: A Matched Multicenter Study. Presented at: AES Annual Meeting; December 2-6, 2022; Nashville, TN, and virtual. SIG.
2. Ferreira-Atuesta C, Döhler N, Erdélyi-Canavese B, et al. Seizures after Ischemic Stroke: A Matched Multicenter Study. 

. 2021;90(5):808-820. doi:10.1002/ana.26212

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Carolina Ferreira Atuesta, MD, MSc. [LISTEN TIME: 26 minutes]

Episode 82: Managing Seizures After Ischemic Stroke

Episode 72, "Updates in Epilepsy Treatment," features an exclusive interview with Christopher Elder, MD, clinical assistant professor of neurology, Comprehensive Epilepsy Center, NYU Langone Health. He joined the show to talk about the latest updates in the care of patients with epilepsy, the clinical therapeutic pipeline developments on the horizon, and the need to continue stressing conversations around sudden unexpected death in epilepsy (SUDEP).

. Check out new episodes of a variety of shows, airing every single day, only on

FDA Approves Midazolam Autoinjector for Status Epilepticus

Sirolimus Topical Gel Available for Facial Angiofibroma Associated With Tuberous Sclerosis Complex

FDA Lifts Hold on Phase 2 Trial of SRP-5051 in DMD Amenable to Exon 51 Skipping

Philips Respironics Recalls Masks for BPAP and CPAP Machines After Safety Concerns

FDA Advisory Committee Votes to Recommend AMX0035 for Treatment of ALS

Episode Breakdown

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Christopher Elder, MD. [LISTEN TIME: 32 minutes]

Episode 72: Updates in Epilepsy Treatment

 podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis (MS), Parkinson disease, dementia, sleep disorders, and more.

This episode, "Ganaxolone Approved for CDD, Fenfluramine Approved for LGS," features exclusive interviews with 2 experts. The first is Scott Demarest, MD, MSCS, neurologist and clinical director of precision medicine, Children’s Hospital Colorado, and assistant professor of pediatrics-neurology, University of Colorado, who was an investigator of the Marigold trial (NCT03572933) of ganaxolone (Ztalmy; Marinus Pharmaceuticals) in cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder, also known as CDD.

 The second is Kelly G. Knupp, MD, MSCS, FAES, pediatric neurologist, Children's Hospital Colorado, and associate professor of pediatrics-neurology, University of Colorado, who was an investigator of Study 1601 (NCT03355209) of fenfluramine (Fintepla; Zogenix/UCB) in Lennox-Gastaut syndrome (LGS).

REFERENCES
1. Marinus Pharmaceuticals Announces FDA Approval of ZTALMY® (ganaxolone) for CDKL5 Deficiency Disorder. News release. March 18, 2022. Accessed March 21, 2022. https://www.businesswire.com/news/home/20220318005282/en/Marinus-Pharmaceuticals-Announces-FDA-Approval-of-ZTALMY%C2%AE-ganaxolone-for-CDKL5-Deficiency-Disorder
2. FINTEPLA® (fenfluramine) Oral Solution Now FDA Approved for Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS). News release. UCB. March 28, 2022. Accessed March 28, 2022. https://finance.yahoo.com/news/fintepla-fenfluramine-oral-solution-now-050000058.html

Mind Moments®, a podcast from NeurologyLive®, brings you exclusive interviews with Scott Demarest, MD, MSCS, and Kelly Knupp, MD, MSCS, FAES. [LISTEN TIME: 21 minutes]

Special Episode: Ganaxolone Approved for CDD, Fenfluramine Approved for LGS

Episode 54, "The Shortage of Neurologists," features an exclusive interview with Jennifer Majersik, MD, MS, chief, division of vascular neurology, and professor of neurology, University of Utah, who along with 9 other colleagues, authored a report from the American Academy of Neurology (AAN) 2019 Transforming Leaders Program on the ongoing shortage of physicians in neurology. She offered her perspective on the challenge and how it can be addressed from an individual and institutional level.

REFERENCES
Majersik JJ, Ahmed A, Chen IA, et al. A shortage of neurologists – we must act now: A report from the AAN 2019 transforming leaders program. 

. Published online April 30, 2021. doi:10.1212/WNL.0000000000012111

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Jennifer Majersik, MD, MS.

Episode 54: The Shortage of Neurologists

The Mind Moments podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis, Parkinson disease, dementia, sleep disorders, and more.

Episode 29, "Developing A Seizure Action Plan," features a conversation with a group of epilepsy experts, including M. Scott Perry, MD, co-director, Jane and John Justin Neurosciences Center, Cook Children’s Hospital; Orrin Devinksy, MD, director, Comprehensive Epilepsy Center, NYU Langone; and Tracy Salazar, PhD, executive director, LGS Foundation. The discussion centered around this week, the inaugural Seizure Action Plan (SAP) Awareness Week, February 8 to 15, 2021, an initiative to raise awareness about the importance of developing SAPs for patients with epilepsy and their caregivers. 

Organized by the SAP Coalition, which is a collaboration of the Dravet Syndrome Foundation, the Lennox-Gastaut Syndrome (LGS) Foundation, and the Tuberous Sclerosis Alliance, the initiative features a social media campaign and new website designed to highlight the need for these plans, especially should an emergency occur.

The SAP Coalition was formed in 2020 by the 

 to fill an unmet need in the epilepsy community: awareness of what an SAP is. The group is aiming to highlight the importance of SAPs in the health management of those with epilepsy, and offer resources to develop an individualized SAP.  

 includes plans, patient stories, and a number of resources for families and health care professionals. 

 to subscribe to the Mind Moments podcast. Be sure to leave a rating and review for the show. Thanks for listening!

Lennox-Gastaut Syndrome Foundation

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive conversation with Scott Perry, MD; Orrin Devinsky, MD; and Tracy Salazar, PhD.

Episode 29: Developing A Seizure Action Plan

Episode 27, "Short, Sudden, Strange, Similar Spells," features an interview with Jacqueline French, MD, director, Translational Research and Clinical Trials in Epilepsy, NYU Grossman School of Medicine. She discussed recently published data from part of the Human Epilepsy Project that suggests the delay in identifying nonvoter seizures can result in injury for the individuals experiencing them, and that earlier identification may prevent this issue.

NYU Langone Health

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Jacqueline French, MD.

Episode 27: Short, Sudden, Strange, Similar Spells

Episode 25, "2020 Wrap-Up: Silver Linings," features an interview with Jennifer Frontera, MD, neuro-intensivist, NYU Langone Health, who we spoke with during the early days of the pandemic. This time, she discussed the complications in determining the cause of death with COVID-19, the need for continued social distancing and mask-wearing, the impact the pandemic has had on her mental health, and her silver linings in spite of these challenges.

Editor's note: This interview was taped pre-vaccine approval in the United States. For updates on the vaccine news, head to 

In that same light, we reached out to a number of physicians across neurology specialties to find out what their silver linings have been for their clinical practice despite the immense adversity that this year has brought. They are, in order of appearance:

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Jennifer Frontera, MD, and a number of others.

Episode 25: 2020 Wrap Up: Silver Linings

Episode 22, "Capitalizing on Collaboration in Neurology Care," features an interview with Paul Fisher, MD, professor of neurology, and chief of child neurology, and Gerald Grant, MD, FACS, endowed professor of neurosurgery, and chief of pediatric neurosurgery, both of the Brain and Behavior Center at Stanford Children’s Health. The pair discussed how their team at the center is bolstering the use of multidisciplinary care and harnessing advances in science to improve the care of children with neurologic disease. Specifically, they spoke to how Stanford Children's Health collaborates across departments and specialties—from neurology to neurosurgery, radiology, nursing, and pathology, among others—as well as its utilization of the technology, talent, and expertise available from the neighboring Stanford Health Care and Stanford University School of Medicine. The model, they noted, is designed in both actions and geography to do pediatrically what Stanford routinely offers for adults.

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Paul Fisher, MD, and Gerald Grant, MD, FACS.

Episode 22: Capitalizing on Collaboration in Neurology Care

Episode 18, "Preventing Tonic-Clonic Seizures in Refractory Epilepsy," features an interview with David Vossler, MD, professor, and medical director, The Neuroscience Institute, UW Medicine Valley Medical Center. He discussed the findings of a recently published phase 3 dataset on lacosamide, also known as Vimpat, and its effects on reducing genetic generalized onset tonic-clonic seizures (previously known as primary generalized tonic clonic seizures).

 to subscribe to the Mind Moments podcast. Thanks for listening!

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with David Vossler, MD.

Episode 18: Preventing Tonic-Clonic Seizures in Refractory Epilepsy

The Mind Moments podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis, Parkinson disease, dementia, sleep disorders, and more. 

Episode 5, "Gut Bacteria and the Brain: An Evolving Role in Epilepsy" features an interview with Daniel Lowenstein, MD, professor of neurology and executive vice chancellor and provost at the University of California, San Francisco (UCSF), where he previously served as director of the UCSF epilepsy center and epilepsy research laboratory. Lowenstein discusses the latest research on how the gut microbiome plays a role in epilepsy, and how altering the gut microbiota may prove to be a very promising therapeutic option in the future. 

"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Daniel Lowenstein, MD. 

Episode 5: The Evolving Role of Gut Bacteria in Epilepsy

Here's some of what is coming soon to NeurologyLive® this week.

This Week on NeurologyLive® — March 20, 2023

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending March 17, 2023.

NeurologyLive® Friday 5 — March 17, 2023

This Week on NeurologyLive® — March 13, 2023

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending March 10, 2023.

NeurologyLive® Friday 5 — March 10, 2023

This Week on NeurologyLive® — March 6, 2023

"It’s slow across generations. My grandparents may have consumed 20% of the sugar I consumed. If you go back for generations, it was probably because sugar became very cheap around the mid 1800s. Before that, people just didn’t use it. It was a luxury."

In the literature, its shown that glucose metabolism can be impaired in epilepsy and contribute to altered neuronal membrane potentials that foster a feed-forward cycle in seizure generation. For patients with treatment-resistant epilepsy, there is evidence that modifying brain metabolism with high fat and low carbohydrate diets may result in reduced seizure frequency. Published in 

a recent study assessed molecular mechanisms in brain tissue and plasma from adults with epilepsy after an average of 10 days of modified Atkins diet (MAD) prior to brain surgical resection relative to those on a non-modified, higher carbohydrate diet.

, the study findings identified altered metabolites in these areas, including increased plasma ketone body 3-hydroxybutryric acid that correlated to cortex levels and altered brain metabolites associated with mitochondrial functions. Additionally, brain proteomics and RNAseq identified few differences, including 2.75-fold increased hippocampal 

and trends in hippocampal nicotinamide adenine dinucleotide (NADH)-related signaling pathways.

Devinsky, director of the Comprehensive Epilepsy Center at 

 to discuss situations in which MAD may be applicable to patients with epilepsy. Additionally, he spoke on the challenges of maintaining maintaining healthy lifestyles in today’s society.

REFERENCE
1. Leitner DF, Siu Y, Korman A, et al. Metabolic, proteomic, and transcriptomic changes in adults with epilepsy on modified Atkins diet. 

Published online February 12, 2023. doi:10.1111/epi.17540

SAP Partners

"One of the opportunities is that we can use that tissue to look at changes in the brain or blood and compare them under a variety of different interventions, from medications that might help reduce seizures to drugs that might affect the mTOR pathway in people with tuberous sclerosis or cortical dysplasia."

The modified Atkins diet (MAD), mainly introduced in the early 2000s, is a less restrictive change to the traditional ketogenic diet. Along with the medium chain triglyceride diet, and low glycemic index treatment, it is 1 of 3 alternative diets to treat patients with epilepsy. MAD differs from ketogenic diets in that there is no fluid or calorie restriction or limitation, as well as no restrictions on proteins. Although fats are strongly encouraged, they are not weighted and measured, and most patients will consume plenty of dairy and oils.

Previous research has shown that high-fat and low-carbohydrate diets can reduce seizure frequency in some treatment-resistant patients with epilepsy, including the more flexible MAD. Led by 

, a recently published study assessed the effect of short-term MAD on molecular mechanisms in adult patients with epilepsy (n = 6) from surgical brain tissue and plasma and compared them to controls (n = 10) consuming a nonmodified higher carbohydrate diet.

All told, results showed 13 increased metabolites in plasma, which included a 4.10-fold increase in ketone body 3-hydroxybutyric acid, decreased palmitic acid in cortex, and 11 decreased metabolites in hippocampus, which had top associations with mitochondrial functions. Additionally, results showed a 2.75-fold increased hippocampal 

 and trends in hippocampal nicotinamide adenine dinucleotide (NADH)-related signaling pathways. Devinsky, director of the Comprehensive Epilepsy Center at 

, sat down for an interview to discuss the reasons behind this study, major take-home points clinicians should be aware of, and the significance of changes in NADH-related pathways.

REFERENCE
1. Leitner DF, Siu Y, Korman A, et al. Metabolic, proteomic, and transcriptomic changes in adults with epilepsy on modified Atkins diet. 

The director of the Comprehensive Epilepsy Center at NYU Langone provided insight on a recently published study assessing the metabolic effects of short-term modified Atkins diet in patients with epilepsy. [WATCH TIME: 4 minutes]

Gaining a Better Understanding of Metabolic Changes in Epilepsy From Dieting: Orrin Devinsky, MD

"The treatment-emergent adverse event percentage was 12% for the ganaxolone group and 9.8% for the placebo group. The discontinuation rate was 4% in the ganaxolone group and 8% in the placebo group. I think this speaks to what this medication brings to the table for the treatment of seizures in children who have CDKL5 deficiency disorder."

CDKL5 deficiency disorder (CDD) is a rare, genetically determined developmental and epileptic encephalopathy characterized by early-onset refractory seizures and severe neurodevelopmental impairment. After years of demonstrating its clinical benefit in trials, the FDA made a landmark decision, greenlighting ganaxolone (Ztalmy; Marinus Pharmaceuticals) as the 

. Approved under priority review and orphan drug and rare pediatric disease designations, the therapy is expected to be available via specialty pharmacy in July 2022.

Ganaxolone, a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor, was accepted based on data from the phase 3 Marigold trial (NCT03572933), a double-blind, placebo-controlled trial that randomized 101 patients. At the 

2022 American Academy of Neurology Annual Meeting (AAN)

, lead investigator Elia Pestana-Knight, MD, presented some of the topline notable data from the study, including the fact that ganaxolone resulted in a median 30.7% reduction in major motor seizure frequency compared with a 6.9% reduction in the placebo group.

Pestana-Knight, pediatric epileptologist at 

 ahead of the meeting to discuss the results in full, along with the significance of ganaxolone’s effect and how it may alter the care for patients with CDD.

REFERENCE
1. Olson H, Moosa AN, Rybak E, et al. Extended Duration Safety and Efficacy of Adjunctive Ganaxolone Treatment in Patients with CDKL5 Deficiency Disorder: 8-Month Minimum Open-Label Extension Follow-up. Presented at: AAN Annual Meeting; April 2-7, 2022; Seattle, WA, and virtual. Abstract 003540.

The pediatric epileptologist at Cleveland Clinic provided insight on her presentation at the 2022 AAN Annual Meeting that evaluated ganaxolone in phase 3 study of patients with CDKL5 deficiency disorder. [WATCH TIME: 4 minutes]

Ganaxolone’s Significant Effect on CDKL5 Deficiency Disorder: Elia Pestana-Knight, MD

“For us at Nationwide Children's Hospital, to be able to participate in those studies would be amazing because the treatments right now work, but they're not great. Opportunities to really make the disease minimized by targeting that gene would be fun that we hope to participate in.”

The pediatric neurologist at Nationwide Children's Hospital discussed the epilepsy research studies that he is excited about in 2023. [WATCH TIME: 4 minutes]  