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In the phase 1 trial, the 2.5 mg dose of ORX750 significantly improved wakefulness, restoring normal sleep latency to 32 minutes compared to placebo.

Centessa to Advance Orexin Agent ORX750 to Phase 2 Studies Following Positive Interim Data

The phase 1 study of RAG-17 in patients SOD1-ALS revealed safety, tolerability, and early clinical benefits across all dose levels.

RAG-17 Shows Promising Results in Early-Stage Study of SOD1 ALS

Videos

Neurology News Network. for the week ending September 14, 2024. [WATCH TIME: 4 minutes]

FDA Supports A-Synuclein Assay for PD Trials, VES001 Meets Primary End Point, Digital Migraine Therapeutic CT-132 Performs

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending September 13, 2024. 

NeurologyLive® Friday 5 — September 13, 2024

At the 2024 AUPN Annual Meeting, a pair of neurologists provided perspectives on the attributes and ethics that make a great educator, stressing passion, intellectual humility, and inclusivity, among others. [WATCH TIME: 5 minutes]

Critical Values and Characteristics in a Successful Neurology Educator: Galina Gheihman, MD; Roy E. Strowd, MD

, has been with the team since September 2022. Follow her on Twitter 

Recent data and conversations with experts highlighted the increasing concern of Long COVID’s impact on the brain in patients who have been previously infected with the virus.

Beyond the Virus: Long COVID’s Neurological Toll 

, has been with the team since October 2019. Follow him on Twitter 

A group of clinician researchers at NYU Langone provided insight on a study presented at AAIC 2024 looking at the correlations between quantitative gait measures and Alzheimer disease biomarkers. [WATCH TIME: 4 minutes]

Understanding the Connection Between Alzheimer Disease Plasma Biomarkers and Gait Dysfunction: Arjun Masurkar, MD, PhD; Waijha Ahmed, MD

Tanya, a patient who lost her mobility due to undiagnosed spinal issues, discussed her life-saving surgery for spinal meningioma, and the complex surgical process she underwent to regain her strength.

Treating Rare Cases of Spinal Meningioma Using Complex Surgical Tactics

NeurologyLive is your direct connection to the latest neurology news and interviews with expert neurologists in multimedia formats.

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AAIC 2024

FEATURE: Long COVID’s Neurological Toll

Clinical Focus

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Video Series

1.125rem

Clinical

 Migraine 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 migraine disorders.

The director at AbbVie discussed a subgroup analysis of the phase 3 ADVANCE study of atogepant in patients with migraine and its benefit on patient-reported outcome measures. 

Atogepant’s Impact on Patient-Reported Outcomes: Lawrence Severt, MD, PhD

AXS-07 has been supported by data from 2 major phase 3 trials in which treatment with the agent led to significant reliefs in pain freedom, the most bothersome symptoms, and acute medication use.

FDA Accepts Resubmitted New Drug Application for Migraine Treatment AXS-07

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 on chronic migraine.

NeurologyLive® Brain Games: September 1, 2024

The director of the MedStar Georgetown Headache Center talked about results from an analysis on the DELIVER study assessing response rates of eptinezumab in patients with migraine over an 18-month period.

NeuroVoices: Jessica Ailani, MD, on Implications of DELIVER Analysis With Eptinezumab for Migraine Prevention

Allison Verhaak, PhD, a clinical psychologist from Ayer Neuroscience Institute at Hartford Healthcare Headache Center, shared her insights on a recent study that explored cannabis use among patients with headache and migraine. 

Surveying the Effect of Cannabis Use for Migraine and Headache Management 

The director of Dysautonomia Clinic talked about the often overlooked triad of dysautonomia, hypermobility spectrum disorder, and mast cell activation syndrome in the field of headache medicine.

NeuroVoices: Svetlana Blitshteyn, MD, FAAN, on the Overlooked Triad of Comorbidities in Headache Medicine

Amaal Starling, MD, FAHS, FAAN, discussed findings from a post-hoc analysis of the phase 3 PREVAIL study assessing eptinezumab in chronic migraine.

Assessing Long-Term Benefit of Eptinezumab for Chronic Migraine: Amaal Starling, MD, FAHS, FAAN

"At two years of treatment, there were 23% of individuals that were previously diagnosed with chronic migraine, that had zero monthly headache days taken from that [Migraine Disability Assessment] headache frequency as a data point."

For patients with migraine experiencing less than 4 monthly headache days (MHDs), preventive treatment may be optimized. Beyond a reduction in frequency, efficacy with preventive migraine treatment can be defined by significant improvements in headache severity and related disability (e.g., Migraine Disability Assessment [MIDAS]). A post hoc analysis of the PREVAIL study (NCT02985398) assessed MIDAS-derived headache frequency, severity, and associated disability in patients with chronic migraine treated with eptinezumab (Vyepti; Lundbeck), an FDA-approved anti-calcitonin gene-related peptide (CGRP) monoclonal antibody used for preventive migraine.

PREVAIL was an open-label phase 3 trial that assessed the long-term safety of eptinezumab in 128 patients with chronic migraine. In the trial, patients received eptinezumab 300 mg every 12 weeks for up to 8 doses, going up to 2 years of treatment. MIDAS was conducted every 12 weeks from baseline to week 84 and at the week 104 follow-up. All told, results from the post-hoc analysis reported that eptinezumab reduced MIDAS-derived headache frequency, pain severity, FSI, and disability over the 2-year study. Notably, many patients achieved less than 4 migraine headache days (MHDs), including an increase in patients reporting 0 MHDs from week 12 to week 104. These findings suggest an added benefit of continuing treatment with overtime and its ability to affect migraine utilizing novel, practical assessments.

These findings were recently presented at the 

2024 American Headache Society (AHS) Annual Meeting

, held June 13-16, in San Diego, California, by coauthor 

 Following the meeting, Starling, an associate professor in the department of neurology at 

 College of Medicine, sat down with NeurologyLive

 in an interview to discuss the significance of achieving less than 4 monthly headache days in the context of chronic migraine treatment. She also spoke about how the Frequency Severity Index helps in evaluating the effectiveness of eptinezumab. Furthermore, Starling talked about the implications of these findings on future preventive treatment strategies for chronic migraine.

Click here for more coverage of AHS 2024.

REFERENCES
1. Lundbeck to Present a Breadth of Migraine and Cluster Headache Data at the 66th Annual Scientific Meeting of the American Headache Society. News Release. Published June 13, 2024. Accessed June 28, 2024. https://www.newsroom.lundbeckus.com/news-release/2024/lundbeck-to-present-a-breadth-of-migraine-and-cluster-headache-data-at-the-66th-annual-scientific-meeting-of-the-american-headache-society
2. Blumenfeld A, Starling AJ, Kudrow D, et al. Long-term reductions in headache frequency, severity, and disability in patients with chronic migraine treated with eptinezumab: post hoc analyses of the PREVAIL study. Available at https://doi.org/10.1111/head.14716. Accessed June 28, 2024.

The associate professor of neurology at Mayo Clinic College of Medicine discussed findings from a post-hoc analysis of the phase 3 PREVAIL study presented at AHS 2024 assessing eptinezumab in patients with chronic migraine. [WATCH TIME: 4 minutes]

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Jessica Ailani, MD, talked about recognizing the struggles of patients with migraine disorders.

A Time to Recognize and Enhance Understanding of Migraine Disorders: Jessica Ailani, MD

"Nobody really thinks of migraine as something to celebrate, but personally, I think celebrating the journey [patients have] been on; to take a moment to share with others what they've gone through, how far they might have come but also to talk to others who they might not realize have a headache disorder to share that there are [clinicians] they can see."

Advancements in preventative treatment options for migraine present opportunities to improve quality of life and individual care plans through shared decision-making. Communicating effectively between patients and clinicians is important for successful migraine prevention and patient-centered care. Presented at the 

, held June 13-16, in San Diego, California, by lead author 

, a recent study provided insight into patient experiences with migraine and revealed opportunities to improve patient and provider alignment in achieving treatment goals.

The surveys were administered to migraine providers (n = 19) and migraine patients (n = 237) from 9 neurology and headache medicine specialty clinics across the US between May 2023 and November 2023. Many patients (45%) and providers (58%) reported barriers in communication regarding migraine symptoms, with the top barrier centered around patient uncertainty on which symptoms to share. Additionally, 33% of providers estimated that their patients did not track their migraine frequency or symptoms and only 20% of patients reported not tracking their attacks or symptoms. For providers, safety was identified as the top barrier to preventative therapy initiation (47%) whereas for patients, not being prescribed a preventative (25%), concerns over adverse effects (25%), and comfort using an over-the-counter acute medication (25%) were documented as top barriers.

Additional findings of the survey showed that many providers and patients reported often or always engaging in shared decision-making in preventative therapy selection (Likert 4/5; 42% vs. 42%, respectively). However, 32% of providers and 19% of patients reported never engaging in shared decision-making. In terms of preventative therapy adherence, 71% of patients reported rarely or never skipping (Likert 1/2) and only 37% of providers thought patients rarely or never skipped their medications. Overall, prioritization of education on migraine and treatment options (providers, 50%; patients, 29%) and discussion of realistic expectations (providers, 33%; patients, 46%) were rated as the top actions that could improve migraine care.

In honor of Migraine and Headache Awareness Month, Ailani, director of the MedStar Georgetown Headache Center, sat down with NeurologyLive

 to discuss some of the positive benefits patients with migraine disorders and providers gain from participating in the awareness activities. In addition, she talked about how the recent scientific discoveries discussed at AHS 2024 can impact the treatment and understanding of migraine disorders. Furthermore, Ailani spoke about the role of the immune system in migraine disorders, and the implications of its relationship for future research and treatment.

REFERENCES
1. Ailani J, Kiarashi J, Kalidas K, et al. Enhancing individualized approaches to migraine prevention through examining provider and patient perspectives. Presented at 2024 AHS Annual Meeting, held June 13-16, in San Diego, California. Abstract P-320.

The director of the MedStar Georgetown Headache Center talked about recognizing the struggles of patients with migraine disorders and the importance of bringing awareness of available treatments to this patient population. [WATCH TIME: 5 minutes]

Dolores D. Santamaria, MD, talked about the evolution of migraine treatments and highlighted the importance of personalized medicine for patients.

The Art of Patient Assessment and Knowledge of Treatment Options in Migraine: Dolores D. Santamaria, MD

"This [migraine] stigma is crumbling down as we're developing and discovering more and more neuronal pathways, and this is just a start [in the field]."

Previous findings in studies showed that patients with migraine were often not aware that they had the condition, which potentially led to ineffective use of treatments. In a prior study published in 

, patients aged less than 40 years were more likely to misidentify their migraine as stress headache and those who were aged 40 years or older were more likely to misidentify their migraine as sinus headache.

 Among the 3074 patients who met with migraine criteria, 54% of them did not know that their headache were migraine. These findings suggested that public education should target patients with severe or disabling headache, to create more awareness of the diagnostic possibilities for migraine.

Not only is education about migraine important for patients but also awareness of the types of treatments available to them and their understanding of their mechanisms is also essential for effective care. In a prior study published in 

, findings revealed that patients who received education at the time of being prescribed triptan had a greater knowledge regarding optimal use of the therapy.

 In addition, triptan users who received this education had greater recognition of the importance of taking the treatment immediately at the onset of a headache, treating when pain was mild, and understood that coronary artery disease was known as a contraindication to use of triptan.

In honor of Migraine and Headache Awareness Month, held June 2024, 

, the director of the Headache Center at 

 in an interview to share her clinical perspective on the recent progress in the migraine field in terms of assessing patients for diagnosis and the different types of treatments that are available for the condition. For example, she provided commentary on how triptan and monoclonal antibodies differed in their mechanisms for treating these patients. She also talked about the role neuronal plasticity plays in the effectiveness of treatments for migraine and how nonpharmacological therapies, such as electric modulation devices, compare with traditional medication in treating this disabling condition.

REFERENCES
1. Lipton RB, Stewart WF, Liberman JN. Self-awareness of migraine: interpreting the labels that headache sufferers apply to their headaches. Neurology. 2002;58(9 Suppl 6):S21-S26. doi:10.1212/wnl.58.9_suppl_6.s21
2. Baron EP, Markowitz SY, Lettich A, et al. Triptan education and improving knowledge for optimal migraine treatment: an observational study. Headache. 2014;54(4):686-697. doi:10.1111/head.12286

The director of the Headache Center at Allegheny Health Network talked about the evolution of migraine treatments and highlighted the importance of personalized medicine for patients living with this disabling condition. [WATCH TIME: 10 minutes]

Fawad Khan, MD, FACNS, FAHS, talked about findings from a study that explored the effect of eptinezumab treatment in a broader chronic migraine population.

The Broader Impact of Eptinezumab for Chronic Migraine Management: Fawad Khan, MD, FACNS, FAHS

"We saw a significant improvement in the number of good days per month, which is amazing because that's how many days that they attribute to having a symptom-free component and also feeling better."

In migraine, some patients with the condition still report that they continue to endure significant disease burden despite the recent advancements in the field for treatments. Due to the controlled design of randomized trials for migraine prevention treatments, many patients with comorbidities or prior exposure to certain therapies are excluded. A recent observational study newly published in 

showed high overall satisfaction with the effectiveness of eptinezumab (Vyepti; Lundbeck) treatment among most patients with chronic migraine and their providers.

 These findings provided evidence of the effectiveness of this treatment in real-world clinical settings which can help shape the future of treatment paradigms.

In the study, dubbed REVIEW, investigators reported that enrolled patients (n = 94) experienced a mean of 8 self-reported "good" days/month before eptinezumab treatment, which increased to 18 after treatment. Following eptinezumab treatment, patients saw decreases of 26% and 23%, respectively, in average days/month on prescription and over-the-counter medication use. For context, coming into the study most patients had an average of at least 10 days/month on prescription.

Prior to eptinezumab treatment, 62% of patients reported being at least slightly concerned about infusions. After eptinezumab infusion, this dropped to 14%. Authors noted that the findings from the patients questioned about eptinezumab were consistent with the responses surveyed from their clinicians.

This study was conducted by senior author Fawad Khan, MD, FACNS, FAHS, a neurologist at Ochsner Medical Center and the director of The McCasland Family Comprehensive Headache Center, and colleagues. Recently, Khan sat down with 

® in an interview to discuss how does the broader study population of this research differs from the original double-blind placebo-controlled studies. He also talked about the specific outcome measures used in this study that deviate from traditional clinical trials. Moreover, Khan spoke about how the reduction in prescription and over-the-counter medication usage among patients with chronic migraine reflects the eptinezumab’s efficacy.

REFERENCES
1. Argoff C, Herzog SP, Smith RM, et al. Real-world effectiveness and satisfaction with intravenous eptinezumab treatment in patients with chronic migraine: REVIEW, an observational, multi-site, US-based study. 

. 2024;25(1):65. Published 2024 Apr 25. doi:10.1186/s10194-024-01764-9

The director of The McCasland Family Comprehensive Headache Center talked about findings from a study that explored the effect of eptinezumab treatment in a broader chronic migraine population. [WATCH TIME: 6 minutes]

Svetlana Blitshteyn, MD, FAAN, talked about advocating for recognition and research into neurological symptoms that have been overlooked in Long COVID

Overlooked Neurological Features Present in Long COVID: Svetlana Blitshteyn, MD, FAAN

"For many years, those of us who specialize in these disorders have seen patients with very similar features that the patients with Long COVID have. Many of them presented [these features] after some viral or bacterial infection."

Following the infection rise from the COVID-19 pandemic, neurologists have diverted attention into trying to understand how their patients can manage the long-term symptoms of this infectious disease. Those previously infected have increasingly reported experiencing symptoms of Long COVID, also known as post-acute COVID, which can last for weeks or more following mild illness. This emerging condition may be related to a virus- or immune-mediated disruption of the autonomic nervous system that can cause orthostatic intolerance syndromes.

As this issue continues to be a prevalent trend, it may be important for neurologists to able to recognize these cases among their patients in order to provide better support toward the management of their condition.

Dysautonomia, often identified by autonomic nervous system dysfunction, includes a variety of disorders with the most frequent reported cases being postural orthostatic tachycardia syndrome, neurocardiogenic syncope, and orthostatic hypotension.

Current Neurology and Neuroscience Reports

, studies showed a significant overlap and shared pathophysiology in migraine and dysautonomia disorders. Author 

, director and founder of Dysautonomia Clinic, noted in the review that diagnosis and treatment of these disorders among those with migraine is crucial for providing patient centered care, reducing symptom burden, and improving functional impairment.

Blitshteyn, who also serves as a clinical associate professor of neurology at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, discussed how the neurological symptoms associated with COVID-19 have shed light on previously neglected post-viral manifestations. She also talked about the initiatives neurologists can undertake to bridge the gap between established medical practices and evolving scientific understanding. In addition, Blitshteyn spoke about the implications of recognizing and addressing neurological manifestations of systemic diseases, such as migraine.

REFERENCE
1. Dani M, Dirksen A, Taraborrelli P, et al. Autonomic dysfunction in 'long COVID': rationale, physiology and management strategies. 

. 2021;21(1):e63-e67. doi:10.7861/clinmed.2020-0896
2. Blitshteyn S. Dysautonomia, Hypermobility Spectrum Disorders and Mast Cell Activation Syndrome as Migraine Comorbidities. 

. 2023;23(11):769-776. doi:10.1007/s11910-023-01307-w

The director of Dysautonomia Clinic talked about advocating for recognition and research into neurological symptoms that have long been overlooked in patients with Long COVID. [WATCH TIME: 3 minutes]

 Jessica Ailani, MD, discussed the importance of maintaining hope and providing understanding of patients' frustrations in their treatment journey for migraine.

Understanding the Impact of Data Analysis on Preventive Migraine Treatment: Jessica Ailani, MD

"I think understanding where the person is coming from is first and foremost, even in our busy days, even when we're like 30 patients in and you're like 'I don't have time for this.' Take that moment, take that deep breath, and realize that a lot of the anger comes from their frustration with the disease process, and reflect that back to them."

Patients with migraine, one of the most disabling neurological conditions globally, may often experience a substantial impairment of their daily activities and quality of life.

 In addition, those with difficult-to-treat migraine may often cycle through different preventive therapies. According to recent cross-sectional analysis published in 

, investigators observed an existence of increased burden, quality-of-life impairment, and functional impairment among patients with migraine who experienced at least 4 monthly headache days and more treatment failures.

These results suggest the need for effective preventive migraine treatments, despite not being able to determine the cause and directionality.

DELIVER is a multi-site, randomized, parallel-group, double-blinded, placebo-controlled trial (NCT04418765) assessing eptinezumab (Vyepti; Lundbeck) as a preventive treatment for patients who have failed between 2 and 4 preventive migraine therapies. A recent analysis of the trial revealed that a clinical response to eptinezumab was maintained in most patients if they reported an at least a 50% migraine response following 1–2 doses of the treatment. For at least 50% responders in the first dose, 61% and 74% maintained an at least 50% response to eptinezumab 100 mg (n = 113) and eptinezumab 300 mg (n = 126), respectively, for 18 months. For those who responded to the first 2 doses of eptinezumab, the percent of patients who maintained a 50% responder status over the remaining 4 doses was 69% (100 mg, n = 128) and 82% (300 mg, n = 131).

, director of the MedStar Georgetown Headache Center, presented these recent findings at the 

2024 American Academy of Neurology (AAN) Annual Meeting

, held April 13-18, in Denver, Colorado. Ailani sat down with 

 at the meeting to discuss how data analysis helps to contribute to shaping treatment approaches for patients with migraine. She also talked about strategies that clinicians can employ to effectively address patients' frustrations and help to maintain hope during the patients’ treatment journey. Additionally, Ailani spoke about how the healthcare system can better support patients with migraine who have experienced disappointment and a sense of failure in their treatment attempts.

Click here for more coverage of AAN 2024.

REFERENCES
1. Pozo-Rosich P, Lucas C, Watson DPB, et al. Burden of Migraine in Patients With Preventive Treatment Failure Attending European Headache Specialist Centers: Real-World Evidence From the BECOME Study. 

. 2021;10(2):1691-1708. doi:10.1007/s40122-021-00331-3
2. Buse DC, Pozo-Rosich P, Dupont-Benjamin L, et al. Impact of headache frequency and preventive medication failure on quality of life, functioning, and costs among individuals with migraine across several European countries: need for effective preventive treatment. 

. 2023;24(1):115. Published 2023 Aug 24. doi:10.1186/s10194-023-01655-5
3. Ailani J, Soni-Brahmbhatt S, Awad S, et al. Long-term Maintenance of ≥50% Migraine Response with Eptinezumab Treatment in Patients with 2–4 Prior Preventive Migraine Treatment Failures. Presented at: 2024 AAN Annual Meeting; April 13-18; Denver, CO.

The director of the MedStar Georgetown Headache Center discussed the importance of maintaining hope and providing understanding of patients' frustrations in their treatment journey for migraine. [WATCH TIME: 5 minutes]

 Jessica Ailani, MD, Center talked about an intravenous migraine treatment that could offer long-term relief for most patients.

Consistent Efficacy of Eptinezumab as Migraine Prevention Treatment: Jessica Ailani, MD

"If you did well, greater than 50% response in that first treatment dose, the chances of you doing well for the full 18 months were very high."

The multi-site, randomized, parallel-group, double-blinded, placebo-controlled DELIVER trial (NCT04418765), assessing eptinezumab (Vyepti; Lundbeck), enrolled patients with migraine who had failed between 2 and 4 previous preventive migraine therapies. Previous findings from DELIVER showed that patients treated with eptinezumab reported significant reductions in mean monthly migraine days (MMDs) and had achieved at least a 50% migraine response compared with placebo over 18 months.

In a recent analysis of the trial, clinical response to eptinezumab preventive treatment was maintained in most patients if they reported an at least a 50% migraine response following the initial 1–2 doses.

The director of the MedStar Georgetown Headache Center talked about an intravenous migraine treatment that could offer long-term relief for most patients who respond well to the initial dose. [WATCH TIME: 5 minutes]

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