EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial

Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH). Of PTH, 50% present with a migraine phenotype which is the most disabling type of PTH. Patients with migraine-PTH are at greater risk of persistent symptoms whereby the acute PTH (aPTH) becomes persistent PTH (pPTH) (ie. lasting > 3 months) with a conversion rate of 47-95%. As migraine symptoms become chronic, it becomes treatment resistant. Despite these implications, early preventive medication management of PTH is marred by lengthy trials of multiple medications (2-3 months for each) and adverse effects that aggravate mTBI symptoms (fatigue, nausea, and presyncope). There is a compelling need to establish an effective treatment to prevent this debilitating outcome. Eptinezumab is a calcitonin gene-related peptide (CGRP)-blocking monoclonal antibody that reduces migraine burden in patients with migraines after a single infusion. Patients with PTH have higher serum levels of CGRP and experimental infusion of CGRP to patients with mTBI reproduces migraine PTH symptoms. Given the similarly in CGRP expression between chronic migraines and PTH, an infusion of eptinezumab within 8 weeks of PTH is hypothesized to reduce headache burden 3 months after treatment and prevent pPTH.

开始日期2026-01-01

申办/合作机构

Sunnybrook Health Sciences Centre

ISRCTN59164978

/ Not yet recruiting临床4期IIT

Eptinezumab for the acute treatment of status migrainosus in the emergency department of a community hospital

开始日期2026-01-01

申办/合作机构

Centre Hospitalier de l'Universite de Montreal

100 项与艾普奈珠单抗相关的临床结果

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100 项与艾普奈珠单抗相关的转化医学

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100 项与艾普奈珠单抗相关的专利（医药）

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237

项与艾普奈珠单抗相关的文献（医药）

2026-06-01·SLEEP MEDICINE REVIEWS

Sleep and anti-calcitonin gene related peptide (CGRP) drugs: current evidence and perspectives

Review

作者: Romozzi, Marina ; Boccalini, Alberto ; Vernieri, Fabrizio ; Geppetti, Pierangelo ; Sebastianelli, Gabriele ; Ray, Sucharita ; Vigani, Giulia ; Altamura, Claudia ; Viticchi, Giovanna ; Iannone, Luigi Francesco

Migraine and sleep share a bidirectional relationship: sleep disruption can trigger migraine attacks, while migraine impairs sleep continuity and quality. Calcitonin gene-related peptide (CGRP), central to migraine pathophysiology, also contributes to sleep regulation through hypothalamic and brainstem circuits that control arousal and circadian rhythms. This overlap raises the question of whether pharmacological inhibition of CGRP with monoclonal antibodies (mAbs) or gepants could affect sleep. This scoping review summarizes evidence on anti-CGRP therapies and their impact on sleep quality, efficacy, and tolerability. Although results are inconsistent across instruments, emerging data suggest that anti-CGRP mAbs and gepants, particularly erenumab, galcanezumab, and atogepant, can improve subjective sleep quality and objective measures such as sleep efficiency in some cases. Evidence for fremanezumab and eptinezumab remains scarce, whereas large-scale pharmacovigilance datasets indicate low rates of insomnia, somnolence, or abnormal dreams. Overall, current findings suggest that CGRP inhibition impacts the sleep system, but the mechanisms of this interaction remain partly understood, representing a promising area for mechanistic exploration and clinical application. Future studies with standardized sleep endpoints are needed to distinguish direct neuropharmacological effects from indirect benefits mediated by improvement in migraine burden.

2026-04-28·NEUROLOGY

Eptinezumab With Patient Education for Chronic Migraine and Medication-Overuse Headache

Article

作者: Vernieri, Fabrizio ; Terwindt, Gisela M. ; Tepper, Stewart J. ; Lundqvist, Christofer ; Blumenfeld, Andrew ; Lanteri-Minet, Michel ; Ettrup, Anders ; Tassorelli, Cristina ; Schytz, Henrik W. ; Lipton, Richard B. ; Jensen, Rigmor Højland ; Jansson, Gary ; Mittoux, Aurélia ; Josiassen, Mette Krog

BACKGROUND AND OBJECTIVES:

Medication-overuse headache (MOH) commonly co-occurs with and complicates chronic migraine (CM). This trial evaluated efficacy and safety of eptinezumab, an anti-calcitonin gene-related peptide monoclonal antibody for migraine prevention-combined with a standardized brief educational intervention (BEI)-in adults with CM and MOH. We report results from the 12-week placebo-controlled period, of which weeks 1-4 was the primary time point.

METHODS:

The phase 4, double-blind, placebo-controlled RESOLUTION trial was conducted at 76 specialist clinics across 11 countries. Eligible participants were adults diagnosed with CM and MOH and were randomized 1:1 to eptinezumab 100 mg IV with BEI or placebo IV with BEI. The primary end point was mean change from baseline in monthly migraine days (MMDs; weeks 1-4). Key secondary end points (multiplicity-controlled) included changes from baseline in monthly headache days, monthly days with acute migraine medication use, and average daily pain, as well as fulfillment of thresholds defining CM and MOH. Treatment-emergent adverse events (TEAEs) were assessed.

RESULTS:

Between July 2022 and March 2025, 608 participants were randomized, and 596 (98%) completed the placebo-controlled period. Of 604 participants treated, 517 (86%) were female and 87 (14%) were male; the mean age was 45.5 years (SD 12.0). The primary end point, mean change from baseline in MMDs (weeks 1-4), favored eptinezumab with BEI vs placebo with BEI (-6.9 vs -3.7; group difference -3.2; 95% CI -4.2 to -2.2; p < 0.0001). All key secondary end points showed statistically significant improvements with eptinezumab with BEI vs placebo with BEI; the greater reductions in disease burden observed during weeks 1-4 were sustained through weeks 1-12. The proportion of participants with TEAEs was similar with eptinezumab (41.9%) and placebo (36.9%); no new safety signals were identified.

DISCUSSION:

In adults with CM and MOH who also received patient education, eptinezumab was statistically superior to placebo on the primary and all key secondary end points, reducing disease burden as early as weeks 1-4 and throughout weeks 1-12. Eptinezumab was generally well tolerated, with no new safety signals identified. Together, data from this trial indicate that eptinezumab in combination with patient education is an effective treatment for reducing disease burden in patients living with CM complicated by medication overuse.

TRIAL REGISTRATION INFORMATION:

ClinicalTrials.gov Identifier: NCT05452239 (clinicaltrials.gov/study/NCT05452239); EudraCT Number: 2021-003049-40 (clinicaltrialsregister.eu/ctr-search/search?query=2021-003049-40); EU CTR Number: 2024-510729-24-00 (euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-510729-24-00). EudraCT Number obtained: May 25, 2021. ClinicalTrials.gov Identifier obtained: July 6, 2022. First patient enrolled: July 1, 2022.

CLASSIFICATION OF EVIDENCE:

This clinical trial provides Class I evidence that eptinezumab with patient education is superior to placebo with patient education in reducing MMDs in adults with CM and MOH.

2026-04-01·Neurology and Therapy

Sustained Efficacy of Eptinezumab in Participants with Migraine for Whom Prior Preventive Treatments Failed and Who Self-reported Psychiatric Comorbidities: Post Hoc Analysis of the Placebo-controlled DELIVER Trial

Article

作者: Pozo-Rosich, Patricia ; Boserup, Line Pickering ; Lee, Xin Ying ; Tassorelli, Cristina ; Ailani, Jessica ; Awad, Susanne F

INTRODUCTION:

Psychiatric comorbidities increase the risk of migraine disease progression. These post hoc analyses explored whether self-reported psychiatric comorbidities at screening had an impact on the short- and long-term efficacy of eptinezumab in the DELIVER trial.

METHODS:

DELIVER was a multinational trial that evaluated eptinezumab in adults with migraine with 2-4 prior preventive treatment failures. Participants were initially randomized to intravenous eptinezumab 100 mg, 300 mg, or placebo every 12 weeks. Participants receiving placebo during the 24-week double-blind placebo-controlled period were switched to eptinezumab 100 mg or 300 mg for the 48-week dose-blinded extension, while those initially randomized to eptinezumab continued their assigned dose. Subgroups included participants self-reporting a psychiatric condition at screening, within which participants self-reporting a depressive condition at screening were also analyzed. Outcomes were changes from baseline in monthly migraine days (MMDs), ≥ 50% migraine responder rates (MRRs), and participants who improved per Patient Global Impression of Change (PGIC; much or very improved). As post hoc analyses, no p-values were generated.

RESULTS:

Of the total population, 122/890 (13.7%) self-reported ≥ 1 psychiatric comorbidity, including 68/890 (7.6%) who self-reported depression. The mean change from baseline in MMDs over Weeks 1-12 in the psychiatric comorbidity subgroup was - 4.6 with eptinezumab versus - 0.9 with placebo, with similar mean changes observed in those with comorbid depression (eptinezumab, - 4.7; placebo, 0.0). In the psychiatric comorbidity subgroup, ≥ 50% MRRs over Weeks 1-12 were higher with eptinezumab (42%; odds ratio [OR] vs placebo = 25.3) than with placebo (3%), as were the proportions of participants with PGIC improvement (eptinezumab, 60%, OR = 6.7; placebo, 19%). During the extension period, participants switching from placebo to eptinezumab reported similar improvements to the eptinezumab-eptinezumab group, with similar outcomes in the subgroups with psychiatric comorbidities.

CONCLUSIONS:

Psychiatric comorbidities, including depressive conditions, did not appear to impact the short- or long-term efficacy of eptinezumab in participants with migraine for whom 2-4 prior preventive treatments had failed.

TRIAL REGISTRATION:

EudraCT (2019-004497-25); ClinicalTrials.gov (NCT04418765).

155

项与艾普奈珠单抗相关的新闻（医药）

2026-04-20

·BioSpace

Lundbeck Presents New Data at AAN 2026 Highlighting Real-World Changes in Migraine-Related Cognitive Symptoms After Starting VYEPTI® (eptinezumab-jjmr)

The one-year INFUSE study observed patient-reported migraine-related cognitive symptoms at baseline and changes over 6 months in those with at least one prior anti-calcitonin gene-related peptide (anti-CGRP) treatment failure DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck today presented new real-world 6-month results from the INFUSE study at the American Academy of Neurology (AAN) 2026 Annual Meeting, underscoring the importance of evaluating the broad burden of migraine beyond headache and migraine frequency. Despite being among the most frequently reported symptoms by people living with migraine, cognition and brain fog have rarely been systematically studied. These patient-reported outcomes data highlight the opportunity to focus on elements of migraine burden that are meaningful to individuals living with migraine and report improvement of migraine-related cognitive symptoms after VYEPTI ® (eptinezumab-jjmr) treatment. 1 VYEPTI is indicated for the preventive treatment of migraine in adults. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of its ingredients. Reactions have included anaphylaxis and angioedema. Please see Important Safety Information below. “Migraine is a highly individualized neurological disease characterized by fluctuating symptoms, disability, and quality-of-life impairment. My patients often describe ‘brain fog’ associated with migraine as profoundly disruptive, hindering their ability to perform at work, engage with family, or simply enjoy daily life,” said INFUSE study author Dr. Amaal Starling, Neurologist, Mayo Clinic. “The INFUSE study findings are meaningful as patients report improvements in cognitive symptoms associated with migraine after starting VYEPTI. These data further support more comprehensive goals with patients who have high disease burden despite prior anti-CGRP preventive treatment to better address their needs and improve outcomes.” Data from the 6-month interim analysis of the INFUSE study underscored the importance of real-world evidence to inform clinical practice with the aim to address the holistic burden of migraine with preventive treatments. This specific analysis focused on cognitive improvements. The study demonstrated that migraine-related cognitive symptoms are highly prevalent and bothersome among patients at baseline. Specific symptoms that were considered moderately to extremely bothersome, like difficulty making decisions, difficulty with reading comprehension, difficulty with complex tasks, and brain fog (difficulty concentrating/focusing, trouble finding right words/speaking, mental cloudiness) were reported by 64.7%, 60.0%, 62.6%, and 82.1% of participants, respectively. This population, characterized by a high disease impact, reported improvements following treatment with VYEPTI. Across individual cognitive symptoms (brain fog, difficulty making decisions, difficulty with reading comprehension and difficulty with complex tasks), more than 50% of participants reported improvements at 6 months (after 2 doses of VYEPTI) compared to baseline, with marked improvements observed as early as Day 7 post-treatment. 1 “These real-world, patient-reported INFUSE data give greater insight into the management of the holistic burden of migraine – including highly prevalent cognitive symptoms – to better support optimal treatment decisions,” said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. “We’re excited to share new data that may help redefine expectations for preventive migraine treatment and reinforce our commitment to raising the standard of migraine care.” Additional VYEPTI data being presented at AAN are: P10 15-006: “ Real-World Effectiveness of Eptinezumab in Patients in Whom ≥1 Prior anti-CGRP Preventive Treatment had Failed: 6-Month Results for an Ongoing Prospective Study ” P10 15-001: “ Eptinezumab’s Effect on Interictal Periods and Quality of Life in Participants with Migraine for Whom 2–4 Prior Preventive Treatments had Failed ” About VYEPTI VYEPTI ® (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. VYEPTI was deliberately developed for administration by IV infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion. The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with VYEPTI discontinued treatment due to adverse reactions. VYEPTI offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information. INDICATION VYEPTI (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and institute appropriate therapy. Hypertension : Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including VYEPTI, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension, and in some cases hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with VYEPTI for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of VYEPTI is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. Raynaud’s Phenomenon : Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. VYEPTI should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms. ADVERSE REACTIONS The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. VYEPTI was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020. For more information, please see Full Prescribing Information and Patient Information or visit . About Migraine Disease Migraine is a complex and disabling neurological disease that limits functionality and quality of life. 2,3 It is characterized by moderate to severe head pain typically accompanied by an array of symptoms, including nausea, vomiting and sensitivity to light or sound. 2 Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration. 4 It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men. 5 Headache disorders are a leading cause of years lived with disability (YLD) among all diseases and is a top 5 cause for 10–24-year-olds, according to the 2019 Global Burden of Disease study. 6 The impact of migraine permeates into career, home life and relationships. 7 About INFUSE study The INFUSE study is a 12-month, prospective, observational study in the US, assessing real-world effectiveness of intravenous (IV) eptinezumab-jjmr (100 mg or 300 mg) in adults with migraine who previously failed at least one preventive anti-CGRP. Data were collected digitally at baseline, Day 7, and Months 3, 6, 9 and 12 through participant-reported surveys. The primary outcome was percent of patients with “much” or “very much” improved on the 7-point PGIC scale (“very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse”). Secondary outcomes included monthly headache days and ≥50% reduction in monthly headache days (MIDAS-derived) and number of patient-defined “good days”. INFUSE did not collect safety data but these data are reported via the established safety reporting channels. About Lundbeck Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long-term value for our shareholders by making positive contributions to patients, their families and society as a whole. Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. Lundbeck US comprises the wholly owned US subsidiaries of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC) (“Lundbeck”), including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. For additional information, please visit Lundbeck.com/us and connect with us on LinkedIn , Instagram , and X at @LundbeckUS . References ___________________________ 1 Starling, A., Estemalik, E., Lipton, R., et al. Real-world Improvements in Cognitive Symptoms After Eptinezumab Treatment in Patients in Whom ≥1 Prior Anti-CGRP Preventive Treatment had Failed: 6-month Results for the Ongoing INFUSE Study. Presented at American Academy of Neurology 2026 Annual Meeting. April 2026. 2 What is migraine? nids.nih.gov 3 Law H. Z., Chung M. H., Nissan G., Janis J. E., Amirlak B. Hospital burden of migraine in United States adults: A 15-year national inpatient sample analysis. 2020. 4 Lipton R. B., Buse D. C., Nahas S. J., et al. Risk factors for migraine disease progression: a narrative review for a patient-centered approach. J Neurol. 2023;270(12):5692-5710. doi:10.1007/s00415-023-11880-2 5 Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review. Headache , 64 (5), 516–532. 6 Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. 7 Buse D. C., Scher A. I., Dodick D. W., et al. Impact of Migraine on the family: Perspectives of people with migraine and their spouse/domestic partner in the CaMEO study. Mayo Clinic . 2016, 91(5):596-611. doi: 10.1016/j.mayocp.2016.02.013 . Contacts Brittany Korb Director, Product and Portfolio Communications brkr@lundbeck.com

临床结果临床3期上市批准

2026-04-19

·动脉网

灵北制药在2026年美国神经病学学会（AAN）上展示了新数据，强调了开始使用VYEPTI®（eptinezumab）后偏头痛相关认知症状在现实世界中的变化

• The one-year INFUSE study observed patient-reported migraine-related cognitive symptoms at baseline and changes over 6 months in those with at least one prior anti-calcitonin gene-related peptide (anti-CGRP) treatment failure • 为期一年的INFUSE研究观察了患者报告的偏头痛相关认知症状在基线时的情况，以及在至少一次先前抗降钙素基因相关肽（anti-CGRP）治疗失败的患者中6个月内的变化。VALBY, Denmark 瓦尔比，丹麦, ，April 19, 2026 2026年4月19日/PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today /PRNewswire/ -- H. Lundbeck A/S（灵北）今天presented 展示了new real-world 6-month results from the INFUSE study at the American Academy of Neurology (AAN) 2026 Annual Meeting, underscoring the importance of evaluating the broad burden of migraine beyond headache and migraine frequency. Despite being among the most frequently reported symptoms by people living with migraine, cognition and brain fog have rarely been systematically studied. 来自INFUSE研究的新现实世界6个月结果在美国神经病学学会（AAN）2026年年会上发布，强调了评估偏头痛的广泛负担的重要性，而不仅仅是头痛和偏头痛频率。尽管认知障碍和脑雾是偏头痛患者最常报告的症状之一，但它们很少被系统地研究。These patient-reported outcomes data highlight the opportunity to focus on elements of migraine burden that are meaningful to individuals living with migraine and report improvement of migraine-related cognitive symptoms after eptinezumab treatment.. 这些患者报告的结果数据突显了关注偏头痛负担中有意义的元素的机会，这些元素对偏头痛患者来说很重要，并且在依普奈珠单抗治疗后报告了偏头痛相关认知症状的改善。[1] [1]'Migraine is a highly individualized neurological disease characterized by fluctuating symptoms, disability, and quality-of-life impairment. My patients often describe 'brain fog' associated with migraine as profoundly disruptive, hindering their ability to perform at work, engage with family, or simply enjoy daily life,' said INFUSE study author Dr. 偏头痛是一种高度个性化的神经系统疾病，其症状、残疾和生活质量受损情况各不相同。INFUSE研究的作者表示：“我的患者经常描述与偏头痛相关的‘脑雾’具有极大的破坏性，会妨碍他们正常工作、与家人互动，甚至无法享受日常生活。”Amaal Starling, Neurologist, Mayo Clinic. 'The INFUSE study findings are meaningful as patients report improvements in cognitive symptoms associated with migraine after starting eptinezumab. These data further support more comprehensive goals with patients who have high disease burden despite prior anti-CGRP preventive treatment to better address their needs and improve outcomes.'. 梅奥诊所神经科医生阿玛尔·斯塔林表示：“INFUSE 研究结果意义重大，因为患者报告在开始使用埃普贴单抗后，偏头痛相关的认知症状有所改善。这些数据进一步支持了更全面的目标，即针对那些尽管之前接受过抗 CGRP 预防治疗但疾病负担仍然较高的患者，更好地满足他们的需求并改善治疗效果。”Data from the 6-month interim analysis of the INFUSE study underscored the importance of real-world evidence to inform clinical practice with the aim to address the holistic burden of migraine with preventive treatments. This specific analysis focused on cognitive improvements. The study demonstrated that migraine-related cognitive symptoms are highly prevalent and bothersome among patients at baseline. INFUSE 研究的 6 个月中期分析数据强调了真实世界证据对于指导临床实践的重要性，目的是通过预防性治疗全面减轻偏头痛的负担。该特定分析聚焦于认知改善。研究表明，在基线时，偏头痛相关的认知症状在患者中非常普遍且令人困扰。Specific symptoms that were considered moderately to extremely bothersome, like difficulty making decisions, difficulty with reading comprehension, difficulty with complex tasks, and brain fog (difficulty concentrating/focusing, trouble finding right words/speaking, mental cloudiness) were reported by 64.7%, 60.0%, 62.6%, and 82.1% of participants, respectively. This population, characterized by a high disease impact, reported improvements following treatment with eptinezumab. 被认为中度到极度困扰的具体症状，如难以做出决定、阅读理解困难、处理复杂任务困难以及脑雾（难以集中注意力/聚焦、找不到合适的词语/说话困难、精神模糊），分别有64.7%、60.0%、62.6%和82.1%的参与者报告。这一群体疾病影响严重，在使用eptinezumab治疗后报告了改善情况。Across individual cognitive symptoms (brain fog, difficulty making decisions, difficulty with reading comprehension and difficulty with complex tasks), more than 50% of participants reported improvements at 6 months (after 2 doses of eptinezumab) compared to baseline, with marked improvements observed as early as Day 7 post-treatment.. 在个体认知症状（脑雾、难以做决定、阅读理解困难和复杂任务困难）方面，超过50%的参与者在6个月时（接受两剂eptinezumab后）报告了相比基线的改善，且治疗后早在第7天就观察到了显著改善。[1] [1]'These real-world, patient-reported INFUSE data give greater insight into the management of the holistic burden of migraine – including highly prevalent cognitive symptoms – to better support optimal treatment decisions,' said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. 'We're excited to share new data that may help redefine expectations for preventive migraine treatment and reinforce our commitment to raising the standard of migraine care.'. “这些来自真实世界、患者报告的INFUSE数据，为全面管理偏头痛的整体负担（包括高度普遍的认知症状）提供了更深入的见解，从而更好地支持最佳治疗决策，”灵北美国医学事务神经学副总裁达米安·菲奥雷表示。“我们很高兴分享可能有助于重新定义偏头痛预防治疗预期的新数据，并强化我们提升偏头痛护理标准的承诺。”Additional eptinezumab data being presented at AAN are: 在AAN上展示的其他eptinezumab数据包括： P10 15-006: P10 15-006:' 'Real-World Effectiveness of Eptinezumab in Patients in Whom ≥1 Prior anti-CGRP Preventive Treatment had Failed: 6-Month Results for an Ongoing Prospective Study 在既往≥1种抗CGRP预防治疗失败的患者中，Eptinezumab的实际有效性：一项正在进行的前瞻性研究的6个月结果' 'P10 15-001: P10 15-001:' 'Eptinezumab's Effect on Interictal Periods and Quality of Life in Participants with Migraine for Whom 2–4 Prior Preventive Treatments had Failed Eptinezumab对2-4种先前预防性治疗失败的偏头痛患者间歇期和生活质量的影响' 'About VYEPTI 关于VYEPTIVYEPTI® (eptinezumab) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. eptinezumab was deliberately developed for administration by intravenous (IV) infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion.. VYEPTI®（eptinezumab）是一种人源化单克隆抗体，可与降钙素基因相关肽（CGRP）配体结合并阻断其与受体的结合。Eptinezumab 专门开发用于通过静脉（IV）输注给药，以在输注结束时将100%的药物递送至血液中。The efficacy and safety of eptinezumab were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. Eptinezumab met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of eptinezumab was evaluated in 2,076 patients with migraine who received at least one dose of eptinezumab. Eptinezumab的疗效和安全性在两项第三阶段临床试验中得到了验证；PROMISE-1中的偶发性偏头痛和PROMISE-2中的慢性偏头痛。Eptinezumab在第1至3个月期间，无论是偶发性还是慢性偏头痛，都达到了减少平均每月偏头痛天数（MMD）的主要终点。Eptinezumab的安全性在2076名接受至少一剂Eptinezumab治疗的偏头痛患者中进行了评估。 The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with eptinezumab discontinued treatment due to adverse reactions.. 在预防性治疗偏头痛的临床试验中，最常见的不良反应（≥2％且至少比安慰剂高2％）是鼻咽炎和超敏反应。在PROMISE-1和PROMISE-2研究中，1.9％接受eptinezumab治疗的患者因不良反应停止治疗。Eptinezumab offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information. . Eptinezumab 为偏头痛患者提供预防性治疗，每年（每三个月）通过一次30分钟的静脉输注进行四次治疗。推荐剂量为100毫克，部分患者可能从300毫克的剂量中获益。剂量应根据处方信息和患者信息中的指导进行确定。VYEPTI (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month. VYEPTI（eptinezumab-jjmr）于2020年2月获得美国食品药品监督管理局（FDA）批准用于成人偏头痛的预防性治疗，并于2022年1月获得欧盟委员会（EC）的上市授权，用于每月至少有四天偏头痛的成人偏头痛预防。Today, eptinezumab is launched in more than 30 markets worldwide.. 今天，eptinezumab已在全世界30多个市场上市。About Migraine Disease 关于偏头痛疾病 Migraine is a complex and disabling neurological disease that limits functionality and quality of life. 偏头痛是一种复杂且致残的神经系统疾病，会限制功能和生活质量。[2] [2],[3] ,[3]It is characterized by moderate to severe head pain typically accompanied by an array of symptoms, including nausea, vomiting and sensitivity to light or sound. 它表现为中度至重度的头部疼痛，通常伴随一系列症状，包括恶心、呕吐以及对光或声音的敏感。[2] [2]Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration. 随着时间的推移，偏头痛疾病可能会恶化，发作频率、严重程度和持续时间都会增加。[4] [4]It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men. 据估计，它在美国影响超过4000万人，并且对女性的影响是男性的三倍。[5] [5]Headache disorders are a leading cause of years lived with disability (YLD) among all diseases and is a top 5 cause for 10–24-year-olds, according to the 2019 Global Burden of Disease study. 根据2019年全球疾病负担研究，头痛障碍是所有疾病中导致伤残调整生命年（YLD）的主要原因之一，也是10-24岁人群的前五大病因之一。[6] [6]The impact of migraine permeates into career, home life and relationships. 偏头痛的影响渗透到职业生涯、家庭生活和人际关系中。[7] [7]About INFUSE study 关于INFUSE研究The INFUSE study is a 12-month, prospective, observational study in the US, assessing real-world effectiveness of IV eptinezumab (100 mg or 300 mg) in adults with migraine who previously failed at least one preventive anti-CGRP. Data were collected digitally at baseline, Day 7, and Months 3, 6, 9 and 12 through participant-reported surveys. INFUSE 研究是一项为期 12 个月的前瞻性、观察性研究，在美国进行，评估静脉注射依普奈珠单抗（100 毫克或 300 毫克）在曾至少使用过一种预防性抗 CGRP 药物失败的成年偏头痛患者中的实际疗效。数据通过参与者报告的调查问卷以数字化方式在基线、第 7 天以及第 3、6、9 和 12 个月收集。The primary outcome was percent of patients with 'much' or 'very much' improved on the 7-point PGIC scale ('very much improved,' 'much improved,' 'minimally improved,' 'no change,' 'minimally worse,' 'much worse,' or 'very much worse'). Secondary outcomes included monthly headache days and ≥50% reduction in monthly headache days (MIDAS-derived) and number of patient-defined 'good days'. 主要结局是7分PGIC量表（“显著改善”、“明显改善”、“轻微改善”、“无变化”、“轻微恶化”、“明显恶化”或“显著恶化”）中“明显改善”或“非常改善”的患者百分比。次要结局包括每月头痛天数、每月头痛天数减少≥50%（基于MIDAS得出）以及患者自定义的“良好天数”数量。INFUSE did not collect safety data but these data are reported via the established safety reporting channels.. INFUSE没有收集安全数据，但这些数据通过既定的安全报告渠道进行报告。Contacts 联系人Anders Crillesen 安德斯·克里勒森Jens Høyer 詹斯·霍伊尔 Senior Director, External & Internal Relations 高级总监，外部及内部关系Vice President, Head of Investor Relations 副总裁，投资者关系主管[email protected] 电子邮件地址[email protected] 电子邮件地址About H. Lundbeck A/S 关于H. Lundbeck A/SLundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. 灵北是一家专注于脑健康的生物制药公司。凭借在神经科学领域70多年的经验，我们致力于改善神经和精神疾病患者的生活。Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. 脑部疾病影响着世界大部分人口，其影响贯穿整个社会。随着对大脑生物学的迅速深入了解，我们通过积极探索治疗的新机会，致力于推动脑健康的发展。As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.. 作为专注的创新者，我们努力使我们的研发计划应对一些最复杂的神经学挑战。我们开发变革性药物，针对那些治疗选择很少或没有的人群，从我们在精神病学和神经学领域的坚实基础上，扩展到神经专科和神经罕见病领域。We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. 我们致力于消除歧视，并采取行动改善健康公平。我们努力通过为患者、他们的家人以及整个社会做出积极贡献，为股东创造长期价值。Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site 灵北公司在20多个国家拥有超过5,000名员工，我们的产品在全球80多个国家有售。欲了解更多信息，我们鼓励您访问我们的企业网站。www.lundbeck.com www.lundbeck.comand connect with us via 并通过以下方式联系我们LinkedIn 领英. 。References 参考文献[1] [1]Starling, A., Estemalik, E., Lipton, R., et al. Real-world Improvements in Cognitive Symptoms After Eptinezumab Treatment in Patients in Whom ≥1 Prior Anti-CGRP Preventive Treatment had Failed: 6-month Results for the Ongoing INFUSE Study. Presented at American Academy of Neurology 2026 Annual Meeting. Starling, A., Estemalik, E., Lipton, R., 等。在既往≥1种抗CGRP预防治疗失败的患者中，依替奈珠单抗治疗后认知症状的现实世界改善：正在进行的INFUSE研究6个月结果。发表于2026年美国神经病学学会年会。April 2026.. 2026年4月[2] [2]What is migraine? nids.nih.gov 什么是偏头痛？ nids.nih.gov[3] [3]Law H. Z., Chung M. H., Nissan G., Janis J. E., Amirlak B. Hospital burden of migraine in United States adults: A 15-year national inpatient sample analysis. 2020. 劳 H. Z., 钟 M. H., 尼桑 G., 贾尼斯 J. E., 阿米尔拉克 B. 美国成人偏头痛的医院负担：一项15年的全国住院样本分析。2020年。[4] [4]Lipton R. B., Buse D. C., Nahas S. J., et al. Risk factors for migraine disease progression: a narrative review for a patient-centered approach. Lipton R. B., Buse D. C., Nahas S. J., 等。偏头痛疾病进展的风险因素：以患者为中心的叙述性综述。J Neurol. 神经病学杂志。2023;270(12):5692-5710. 2023；270（12）：5692-5710。[5] [5]Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review. 科恩，F.，布鲁克斯，C. V.，孙，D.，布斯，D. C.，里德，M. L.，范宁，K. M.，& 利普顿，R. B. (2024). 美国偏头痛的流行率与负担：一项系统性综述。Headache 头痛, ，64 64(5), 516–532. (5), 516–532。[6] [6]Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. 1990年至2019年，204个国家和地区的369种疾病和伤害的全球负担：2019年全球疾病负担研究的系统分析。[7] [7]Buse D. C., Scher A. I., Dodick D. W., et al. Impact of Migraine on the family: Perspectives of people with migraine and their spouse/domestic partner in the CaMEO study. Buse D. C., Scher A. I., Dodick D. W., 等。偏头痛对家庭的影响：CaMEO 研究中偏头痛患者及其配偶/同居伴侣的视角。Mayo Clinic 梅奥诊所. 2016, 91(5):596-611. . 2016, 91(5):596-611.CONTACT: 联系人：H. Lundbeck A/S H. Lundbeck A/SOttiliavej 9, 2500 Valby, Denmark 丹麦瓦尔比奥蒂莉亚街9号，邮编2500 +45 3630 1311 +45 3630 1311[email protected] 电子邮件地址This information was brought to you by Cision 此信息由Cision提供给您http://news.cision.com http://news.cision.comhttps://news.cision.com/h--lundbeck-a-s/r/lundbeck-presents-new-data-at-aan-2026-highlighting-real-world-changes-in-migraine-related-cognitive,c4336771 https://news.cision.com/h--lundbeck-a-s/r/lundbeck-presents-new-data-at-aan-2026-highlighting-real-world-changes-in-migraine-related-cognitive,c4336771The following files are available for download: 以下文件可供下载：https://mb.cision.com/Main/18215/4336771/4044578.pdf https://mb.cision.com/Main/18215/4336771/4044578.pdfGlobal AAN INFUSE Final 全球AAN INFUSE决赛21 21% %more press release views with 更多新闻稿浏览量与 Request a Demo 请求演示

2026-04-19

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Lundbeck presents new data at AAN 2026 highlighting real-world changes in migraine-related cognitive symptoms after starting VYEPTI® (eptinezumab)

• The one-year INFUSE study observed patient-reported migraine-related cognitive symptoms at baseline and changes over 6 months in those with at least one prior anti-calcitonin gene-related peptide (anti-CGRP) treatment failure VALBY, Denmark, April 19, 2026 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today presented new real-world 6-month results from the INFUSE study at the American Academy of Neurology (AAN) 2026 Annual Meeting, underscoring the importance of evaluating the broad burden of migraine beyond headache and migraine frequency. Despite being among the most frequently reported symptoms by people living with migraine, cognition and brain fog have rarely been systematically studied. These patient-reported outcomes data highlight the opportunity to focus on elements of migraine burden that are meaningful to individuals living with migraine and report improvement of migraine-related cognitive symptoms after eptinezumab treatment.[1] "Migraine is a highly individualized neurological disease characterized by fluctuating symptoms, disability, and quality-of-life impairment. My patients often describe 'brain fog' associated with migraine as profoundly disruptive, hindering their ability to perform at work, engage with family, or simply enjoy daily life," said INFUSE study author Dr. Amaal Starling, Neurologist, Mayo Clinic. "The INFUSE study findings are meaningful as patients report improvements in cognitive symptoms associated with migraine after starting eptinezumab. These data further support more comprehensive goals with patients who have high disease burden despite prior anti-CGRP preventive treatment to better address their needs and improve outcomes." Data from the 6-month interim analysis of the INFUSE study underscored the importance of real-world evidence to inform clinical practice with the aim to address the holistic burden of migraine with preventive treatments. This specific analysis focused on cognitive improvements. The study demonstrated that migraine-related cognitive symptoms are highly prevalent and bothersome among patients at baseline. Specific symptoms that were considered moderately to extremely bothersome, like difficulty making decisions, difficulty with reading comprehension, difficulty with complex tasks, and brain fog (difficulty concentrating/focusing, trouble finding right words/speaking, mental cloudiness) were reported by 64.7%, 60.0%, 62.6%, and 82.1% of participants, respectively. This population, characterized by a high disease impact, reported improvements following treatment with eptinezumab. Across individual cognitive symptoms (brain fog, difficulty making decisions, difficulty with reading comprehension and difficulty with complex tasks), more than 50% of participants reported improvements at 6 months (after 2 doses of eptinezumab) compared to baseline, with marked improvements observed as early as Day 7 post-treatment.[1] "These real-world, patient-reported INFUSE data give greater insight into the management of the holistic burden of migraine – including highly prevalent cognitive symptoms – to better support optimal treatment decisions," said Damian Fiore, Vice President, Lundbeck US Medical Affairs Neurology. "We're excited to share new data that may help redefine expectations for preventive migraine treatment and reinforce our commitment to raising the standard of migraine care." Additional eptinezumab data being presented at AAN are: P10 15-006: "Real-World Effectiveness of Eptinezumab in Patients in Whom ≥1 Prior anti-CGRP Preventive Treatment had Failed: 6-Month Results for an Ongoing Prospective Study" P10 15-001: "Eptinezumab's Effect on Interictal Periods and Quality of Life in Participants with Migraine for Whom 2–4 Prior Preventive Treatments had Failed" About VYEPTI VYEPTI® (eptinezumab) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. eptinezumab was deliberately developed for administration by intravenous (IV) infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion. The efficacy and safety of eptinezumab were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. Eptinezumab met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of eptinezumab was evaluated in 2,076 patients with migraine who received at least one dose of eptinezumab. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with eptinezumab discontinued treatment due to adverse reactions. Eptinezumab offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information. VYEPTI (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in more than 30 markets worldwide. About Migraine Disease Migraine is a complex and disabling neurological disease that limits functionality and quality of life.[2],[3] It is characterized by moderate to severe head pain typically accompanied by an array of symptoms, including nausea, vomiting and sensitivity to light or sound.[2] Over time, migraine disease may worsen, with attacks increasing in frequency, severity and duration.[4] It is estimated to affect more than 40 million people in the U.S. and impacts three times as many women than men.[5] Headache disorders are a leading cause of years lived with disability (YLD) among all diseases and is a top 5 cause for 10–24-year-olds, according to the 2019 Global Burden of Disease study.[6] The impact of migraine permeates into career, home life and relationships.[7] About INFUSE study The INFUSE study is a 12-month, prospective, observational study in the US, assessing real-world effectiveness of IV eptinezumab (100 mg or 300 mg) in adults with migraine who previously failed at least one preventive anti-CGRP. Data were collected digitally at baseline, Day 7, and Months 3, 6, 9 and 12 through participant-reported surveys. The primary outcome was percent of patients with "much" or "very much" improved on the 7-point PGIC scale ("very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse"). Secondary outcomes included monthly headache days and ≥50% reduction in monthly headache days (MIDAS-derived) and number of patient-defined "good days". INFUSE did not collect safety data but these data are reported via the established safety reporting channels. Contacts About H. Lundbeck A/S Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site and connect with us via LinkedIn. References [1] Starling, A., Estemalik, E., Lipton, R., et al. Real-world Improvements in Cognitive Symptoms After Eptinezumab Treatment in Patients in Whom ≥1 Prior Anti-CGRP Preventive Treatment had Failed: 6-month Results for the Ongoing INFUSE Study. Presented at American Academy of Neurology 2026 Annual Meeting. April 2026. [2] What is migraine? nids.nih.gov [3] Law H. Z., Chung M. H., Nissan G., Janis J. E., Amirlak B. Hospital burden of migraine in United States adults: A 15-year national inpatient sample analysis. 2020. [4] Lipton R. B., Buse D. C., Nahas S. J., et al. Risk factors for migraine disease progression: a narrative review for a patient-centered approach. J Neurol. 2023;270(12):5692-5710. [5] Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review. Headache, 64(5), 516–532. [6] Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. [7] Buse D. C., Scher A. I., Dodick D. W., et al. Impact of Migraine on the family: Perspectives of people with migraine and their spouse/domestic partner in the CaMEO study. Mayo Clinic. 2016, 91(5):596-611. CONTACT: H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Denmark +45 3630 1311 [email protected] This information was brought to you by Cision The following files are available for download: 21% more press release views with Request a Demo

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KEGG	Wiki	ATC	Drug Bank
-	艾普奈珠单抗	L01XC	DB14040

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适应症	国家/地区	公司	日期
偏头痛	美国	Lundbeck Seattle BioPharmaceuticals, Inc.	2020-02-21

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适应症	最高研发状态	国家/地区	公司	日期
药物引起的头痛	临床3期	美国	H. Lundbeck A/S	2021-02-17
药物引起的头痛	临床3期	韩国	H. Lundbeck A/S	2021-02-17
药物引起的头痛	临床3期	西班牙	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	美国	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	中国	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	韩国	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	西班牙	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	中国台湾	H. Lundbeck A/S	2021-02-17
丛集性头痛	临床3期	美国	H. Lundbeck A/S	2020-12-23
丛集性头痛	临床3期	日本	H. Lundbeck A/S	2020-12-23

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04418765 (DELIVER, Pubmed \| Neurol Ther)	临床3期	偏头痛	890	Eptinezumab 100 mg	鬱壓鑰壓積觸憲夢膚夢(蓋蓋鏇衊糧壓獵製齋鹹) = 願鑰鹹壓鏇遞製夢築夢簾觸衊網遞鑰壓衊醖範 (糧艱觸齋窪觸壓憲醖鏇 ) 更多	积极	2026-02-11
				Placebo	鬱壓鑰壓積觸憲夢膚夢(蓋蓋鏇衊糧壓獵製齋鹹) = 衊遞鏇襯壓構夢糧廠網簾觸衊網遞鑰壓衊醖範 (糧艱觸齋窪觸壓憲醖鏇 ) 更多
NEWS 人工标引	N/A	偏头痛	111	Eptinezumab	醖遞窪衊夢艱製願衊糧(廠鏇構鹹淵壓遞鑰糧範) = 願糧壓網獵願鹽鏇築鑰觸壓壓襯範願網糧壓夢 (鑰艱窪壓鏇鬱襯築餘遞 ) 更多	积极	2026-01-30
NCT05452239 (RESOLUTION, CTgov)	临床4期	偏头痛 \| 继发性头痛症	608	Eptinezumab (Placebo-controlled Period: Eptinezumab)	糧餘餘觸簾襯簾膚憲遞(餘選襯壓齋築蓋廠夢衊) = 鑰醖齋窪遞遞築醖築蓋積夢艱糧衊蓋齋襯願鏇 (糧選鏇衊簾網窪膚鬱艱, 0.518) 更多	-	2025-12-04
				placebo+eptinezumab (Placebo-controlled Period: Placebo)	糧餘餘觸簾襯簾膚憲遞(餘選襯壓齋築蓋廠夢衊) = 壓築鹽衊獵簾淵繭構艱積夢艱糧衊蓋齋襯願鏇 (糧選鏇衊簾網窪膚鬱艱, 0.519) 更多
NCT04921384 (SUNRISE, Pubmed \| Cephalalgia)	临床3期	偏头痛	978	Eptinezumab 100 mg	-	积极	2025-10-01
				Eptinezumab 300 mg
RESOLUTION (PRNewswire) 人工标引	临床4期	偏头痛 \| 头痛	608	brief educational intervention (BEI) + eptinezumab	膚淵衊積淵觸膚選艱簾(糧築鑰膚艱獵鏇壓繭網) = 鑰憲糧膚膚鹹繭鑰簾壓選觸願壓鬱廠範艱夢觸 (築鑰簾築遞積鹽窪蓋壓 ) 更多	积极	2025-09-11
				brief educational intervention (BEI) + placebo	-
NCT05064371 (SUNSET, PRNewswire) 人工标引	临床3期	偏头痛	159	Eptinezumab 100 mg	膚窪願網廠憲齋廠糧繭(繭廠製構觸膚範構鹹獵) = 鹽鏇鹽顧網艱鑰顧憲簾獵衊網襯衊選網膚淵選 (鬱顧鏇鏇餘構襯襯衊夢 )	积极	2025-09-11
				Eptinezumab 300 mg	-
NCT04688775 (ALLEVIATE, Pubmed \| JAMA Neurol) 人工标引	临床3期	丛集性头痛	231	Eptinezumab 400 mg	鹹繭餘鹹齋衊廠網積窪(襯壓襯糧繭簾鏇襯夢獵) = 醖獵夢遞廠獵鹹構鑰鏇遞顧願鏇醖範淵獵鏇願 (選簾醖餘糧齋選簾積膚, 8.1) 更多	积极	2025-07-01
				Placebo	鹹繭餘鹹齋衊廠網積窪(襯壓襯糧繭簾鏇襯夢獵) = 襯鹹鏇憲窪鹽醖糧蓋範遞顧願鏇醖範淵獵鏇願 (選簾醖餘糧齋選簾積膚, 8.3) 更多
AAN2025	临床3期	偏头痛维持	858	Eptinezumab 100 mg	獵壓膚遞鏇糧壓壓憲衊(蓋鏇醖醖願鏇獵憲選繭) = 蓋築夢觸獵艱窪鬱築壓鹽鏇簾築構夢艱鬱齋憲 (壓繭襯襯襯範繭糧廠餘 ) 更多	积极	2025-04-07
				Eptinezumab 300 mg	獵壓膚遞鏇糧壓壓憲衊(蓋鏇醖醖願鏇獵憲選繭) = 鹽鏇憲鑰構鬱夢觸構願鹽鏇簾築構夢艱鬱齋憲 (壓繭襯襯襯範繭糧廠餘 ) 更多
P12-12.010 (AAN2025)	N/A	偏头痛	94	Eptinezumab (≥75% increase in good days/month)	顧廠艱製艱窪積繭廠窪(製艱膚醖鹹網艱積糧選) = 鬱選築獵積製顧鹹廠積夢窪鹹憲積顧鹽範齋壓 (憲遞繭遞淵鹹網餘觸憲 )	积极	2025-04-07
				Eptinezumab (<75% increase in good days/month)	顧廠艱製艱窪積繭廠窪(製艱膚醖鹹網艱積糧選) = 鹹齋淵醖襯蓋網壓淵齋夢窪鹹憲積顧鹽範齋壓 (憲遞繭遞淵鹹網餘觸憲 )
AAN2025	临床3期	偏头痛	128	Eptinezumab 300 mg	窪壓選糧艱艱繭鬱網觸(繭淵觸選糧廠鏇願餘鏇) = 鑰廠製顧醖鑰簾膚觸鹽憲醖餘膚鬱繭願蓋夢蓋 (淵觸願糧窪夢願艱廠鬱 ) 更多	积极	2025-04-07