CAT-Trial: CGRP Monoclonal Antibody for Treatment of Painful Diabetic Neuropathy: a Double-blind, Randomized, Placebo-controlled, International Multicenter, Phase II Clinical Trial

The main purpose of this study is to compare the change in pain intensity during treatment with a CGRP monoclonal antibody (eptinezumab) compared with placebo treatment in patients with painful diabetic polyneuropathy (DPN).

开始日期2025-01-01

申办/合作机构

Mayo Clinic

NCT06701526

/ Recruiting临床4期

Interventional, Open-label Trial, Investigating the Effectiveness of Eptinezumab in Participants With Migraine and Previous Inadequate Response to CGRP-targeting Therapies

The main goal of this trial is to learn whether eptinezumab improves migraine symptoms and quality of life of participants with migraine who did not perceive a sufficient improvement during previous treatment with therapies targeting calcitonin gene-related peptide (CGRP).

开始日期2024-12-18

申办/合作机构

H. Lundbeck A/S

NCT06628921

/ Not yet recruitingN/A

The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study): a TACHIS Sub-study

A perspective and multicentric study to evaluate the efficacy of eptinezumab administered during a migraine attack. During the intravenous infusion of eptinezumab, some patients experiencing an ongoing migraine attack report its resolution. This finding is known in the literature, having been described in the RELIEF study. This study was designed to also evaluate, in a real-world setting, the efficacy of eptinezumab in resolving the ongoing attack and the time frame within which the attack is resolved.
The study includes all patients who will begin treatment according to clinical practice, and are included in the TACHIS study (NCT06409845, Unique protocol ID RICe_5)

开始日期2024-10-30

申办/合作机构

University of Florence

[+1]

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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项与艾普奈珠单抗相关的文献（医药）

2025-03-01·ANNALS OF INTERNAL MEDICINE

Prevention of Episodic Migraine Headache Using Pharmacologic Treatments in Outpatient Settings: A Clinical Guideline From the American College of Physicians

Review

作者: Shekelle, Paul G. ; Cooney, Thomas G. ; Yost, Jennifer ; Cross, J. Thomas ; Tice, Jeffrey A. ; Fitterman, Nick ; Obley, Adam J. ; Owens, Douglas K. ; Miller, Matthew C. ; Qaseem, Amir ; Shamliyan, Tatyana ; Etxeandia-Ikobaltzeta, Itziar ; Harrod, Curtis S. ; Linsky, Amy M. ; Hicks, Lauri A. ; Wilt, Timothy J. ; Crandall, Carolyn J. ; Lewis, Johanna ; Maroto, Michael

DESCRIPTION:

The American College of Physicians (ACP) developed this clinical guideline for clinicians caring for adults with episodic migraine headache (defined as 1 to 14 headache days per month) in outpatient settings.

METHODS:

ACP based these recommendations on systematic reviews of the comparative benefits and harms of pharmacologic treatments to prevent episodic migraine, patients' values and preferences, and economic evidence. ACP evaluated the comparative effectiveness of the following interventions: angiotensin-converting enzyme inhibitors (lisinopril), angiotensin II-receptor blockers (candesartan and telmisartan), antiseizure medications (valproate and topiramate), β-blockers (metoprolol and propranolol), calcitonin gene-related peptide (CGRP) antagonist-gepants (atogepant or rimegepant), CGRP monoclonal antibodies (eptinezumab, erenumab, fremanezumab, or galcanezumab), selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors (fluoxetine and venlafaxine), and a tricyclic antidepressant (amitriptyline). ACP used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to analyze the effects of pharmacologic treatment on the following outcomes: migraine frequency and duration, number of days medication was taken for acute treatment of migraine, frequency of migraine-related emergency department visits, migraine-related disability, quality of life and physical functioning, and discontinuations due to adverse events. In addition, adverse events were captured through U.S. Food and Drug Administration medication labels and eligible studies.

RECOMMENDATIONS:

In this guideline, ACP makes recommendations for clinicians to initiate monotherapy for episodic migraine prevention in nonpregnant adults in the outpatient setting as well as alternative approaches if initial treatments are not tolerated or result in an inadequate response. All 3 ACP recommendations have conditional strength and low-certainty evidence. Clinical considerations provide additional context for physicians and other clinicians.

2025-02-01·HEADACHE

Pharmacological differences and switching among anti‐CGRP monoclonal antibodies: A narrative review

Review

作者: Romozzi, Marina ; Vigani, Giulia ; Rivi, Veronica ; Raffaelli, Bianca ; Burgalassi, Andrea ; Iannone, Luigi Francesco ; Calabresi, Paolo ; Guerzoni, Simona ; Munafò, Antonio ; De Cesaris, Francesco ; Altamura, Claudia

Abstract:

Antibodies targeting either the calcitonin gene–related peptide (CGRP), such as galcanezumab, fremanezumab, and eptinezumab, or the receptor (erenumab) have been approved for the prevention of episodic and chronic migraine. Although widely used and generally effective, a proportion of patients discontinue treatment due to lack of efficacy. In both randomized controlled trials and observational studies, all anti‐CGRP monoclonal antibodies (mAbs) have consistently demonstrated comparable efficacy and tolerability, suggesting a pharmacological class effect. However, differences in therapeutic targets, structure, and pharmacokinetic characteristics may influence their efficacy and safety differently. Therefore, in patients not achieving a clinically meaningful response with one anti‐CGRP antibody, switching to a different antibody may be a viable option. This review examines the pharmacological characteristics and distinctions among anti‐CGRP mAbs, highlighting their mechanisms of action and pharmacokinetic profiles, along with the clinical observational data of switching. Finally, we summarize suggestions from international guidelines.

2025-01-01·HEADACHE

Long‐term reductions in acute headache medication use after eptinezumab treatment in patients with migraine and prior preventive treatment failures: Post hoc analysis of the DELIVER randomized trial

Article

作者: Ettrup, Anders ; Sperling, Bjørn ; Boserup, Line Pickering ; Gryglas‐Dworak, Anna ; Ranc, Kristina ; Josiassen, Mette Krog ; Schim, Jack ; Ashina, Messoud

Abstract:

Objective:

To evaluate long‐term reductions in acute headache medication (AHM) use with eptinezumab versus placebo in patients with prior preventive migraine treatment failures and medication overuse (MO).

Background:

Preventive migraine treatment is recommended for patients for whom AHMs have failed and for those who are using excessive amounts of AHM. MO may worsen headache and migraine symptoms in people with migraine; it is a risk factor for disease chronification and/or MO headache.

Methods:

DELIVER was a multicenter, parallel‐group, double‐blind, randomized, placebo‐controlled, phase 3b clinical trial that randomized adults with migraine and two to four prior preventive failures to eptinezumab 100 mg, 300 mg, or placebo infusion every 12 weeks; patients initially given placebo received eptinezumab 100 mg or 300 mg in the extension period. MO was defined according to diagnostic criteria for MO headache in the baseline diary reports. This post hoc analysis of the DELIVER study included change from baseline in AHM days/month of use (ergotamines, triptans, simple or combination analgesics, and opioids; total and select class‐specific use) in the MO population.

Results:

A total of 890 patients were included in the total population, and 438/890 (49.2%) had MO at baseline. In both the total population and MO population, eptinezumab resulted in greater reductions in total AHM days/month of use during weeks 1–24 than placebo, with triptans showing the largest reduction among AHM classes. Patients switching from placebo to eptinezumab experienced reductions in AHM days/month similar to that of initial eptinezumab treatment. In the extension population, mean (standard error [SE]) changes from baseline in AHM days/month were −4.6 (0.32; 100 mg) and −4.8 (0.32; 300 mg) across weeks 1–4 in patients who received eptinezumab for the entire treatment period and were −4.8 (0.44; placebo–100 mg) and −5.5 (0.44; placebo–300 mg) across weeks 25–28 in patients who switched from placebo to eptinezumab. Mean (SE) changes from baseline in AHM days/month in the extension MO population were −6.5 (0.59; 100 mg) and −6.6 (0.57; 300 mg) across weeks 1–4 in patients who received eptinezumab for the entire treatment period and were −7.1 (0.81; 100 mg) and −8.0 (0.80; 300 mg) across weeks 25–28 in patients who were switched from placebo to eptinezumab. All treatment arms sustained or further reduced AHM use across 18 months of trial participation. Across weeks 1–4, in patients fulfilling criteria for MO at baseline, 68.0% (102/150) of patients treated with eptinezumab 100 mg and 74.7% (109/146) of patients treated with eptinezumab 300 mg reported AHM use below MO thresholds compared to 43.3% (61/141) of patients receiving placebo. In patients with MO at baseline, the proportion of patients without MO remained above 60.0% for all treatment groups during the extension period.

Conclusions:

Eptinezumab reduced total AHM use more than placebo in patients with prior preventive failures and in patients with MO at baseline; largest reductions were observed for triptans. Robust reductions in AHM use after eptinezumab were sustained or further reduced with up to 18 months of treatment, and most patients no longer met thresholds for MO.

项与艾普奈珠单抗相关的新闻（医药）

2025-04-04

·PRNewswire

Lundbeck to present positive pipeline data at American Academy of Neurology (AAN) Annual Meeting

VALBY, Denmark, April 4, 2025 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) will present positive interim results from the open-label extension of the PACIFIC trial investigating bexicaserin, in addition to new analyses from clinical trials and real-world data with eptinezumab. H. Lundbeck A/S (Lundbeck) today announced that recent pipeline data will be presented at the 2025 AAN Annual Meeting in San Diego, U.S. The data includes an oral presentation of the six-month results from the open-label extension (OLE) of the Phase 1b/2a PACIFIC trial of bexicaserin, a novel treatment under development for seizures associated with Developmental and Epileptic Encephalopathies (DEEs).1 DEEs are the most severe group of epilepsies characterized by drug-resistant seizures, and developmental slowing or regression.2 "DEEs can be caused by a range of acquired, syndromal, and genetic etiologies, with more than 900 genes implicated. However, only a few subtypes currently have approved therapies, leaving many patients in need. The DEE-inclusive PACIFIC trial and six-month OLE data indicate that bexicaserin may be able to help address this unmet need across multiple DEE types, and highlights Lundbeck's expanding commitment to the neuro-rare space. We look forward to engaging with the global neuroscience community at AAN to discuss the data and potential of bexicaserin to support patients, caregivers and healthcare professionals in the management of DEEs," said Johan Luthman, EVP and Head of Research & Development at Lundbeck. The OLE included patients who successfully completed the PACIFIC trial3 and was designed to evaluate the long-term safety (up to 52 weeks), tolerability, and efficacy of bexicaserin in a cohort of participants with DEEs who were newly exposed to bexicaserin for at least 6 months.1 The OLE interim analysis showed that bexicaserin continues to exhibit a favourable safety and tolerability profile at six months, consistent with the safety profile observed during the PACIFIC trial. All bexicaserin treatment-naive patients (n=9) successfully transitioned from placebo to bexicaserin, reinforcing the tolerability of bexicaserin in an inclusive DEE population. In this placebo-bexicaserin switch population, a 57.3% reduction in countable motor seizures and 61.2% reduction in total seizures was observed, consistent with the response in non-naive participants at 6 months (n=32).* Moreover, more than half of patients newly exposed to bexicaserin (n=5/9) experienced a ≥50% reduction from baseline in countable motor seizures.1* In addition, Lundbeck will present recent post-hoc analyses and real-world data for eptinezumab investigating meaningful endpoints, such as good days per month†, and sustained treatment response. Lundbeck remains focused on raising the bar around preventive treatment expectations in migraine and increasing the understanding of the holistic impact of migraine on quality of life. *As compared to baseline at entry into PACIFIC study. †As reported by trial patients based on individual migraine experience Details of Lundbeck presentations at AAN 2025: Bexicaserin Oral Presentation Monday, April 7, Session S20, 4:18 – 4:30pm PT Title: Safety, Tolerability, and Efficacy of Bexicaserin in a Cohort of Participants with Developmental and Epileptic Encephalopathies: Interim Results of a Phase 1b/2a PACIFIC Study Open-Label Extension Eptinezumab Poster Presentations: Title: Long-term Maintenance of ≥50% and ≥75% Migraine Response With Eptinezumab in Patients With High-frequency Episodic Migraine and Chronic Migraine and 2-4 Prior Migraine Preventive Treatment Failures4 I Poster number: P12.005 Title: Patient-reported Impact of ≥75% Increase in Good Days/Month on Migraine Symptoms, Quality of Life, and Brain Fog: Real-world Study of Adults With Chronic Migraine Treated With Eptinezumab5 I Poster number: P12.010 Title: Long-term Reductions in Monthly Headache Days With Eptinezumab Treatment in Adults With Chronic Migraine: Results From the PREVAIL Study6 I Poster number: P12.003 About Bexicaserin Bexicaserin (LP352) is an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist with no observed impact on 5-HT2B and 5-HT2A receptor subtypes. It is being evaluated in a global Phase III clinical program (the DEEp Program). The FDA has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age and older. Bexicaserin is an investigational compound that is not approved for marketing by any regulatory authority worldwide. The PACIFIC trial was a randomised, double-blind, placebo-controlled, DEE-inclusive trial (NCT05364021) in 52 participants with Dravet syndrome, Lennox-Gastaut syndrome, or DEE Other, who had ≥4 countable motor seizures during the 28-day baseline period, and who were on a stable regimen of 1 to 4 concomitant antiseizure medications.3 About eptinezumab (Vyepti®) Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was purposefully developed for IV administration. The efficacy and safety of eptinezumab 100 mg and 300 mg was investigated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), where eptinezumab met its primary endpoint of decrease in mean monthly migraine days (MMD) over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program observed a treatment benefit over placebo that was observed for both doses of eptinezumab as early as day 1 post-infusion. The safety of eptinezumab was evaluated in more than 2,000 adult patients with migraine who received at least one dose of eptinezumab. 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. Approximately 8% of patients on 300 mg, 6% of patients on 100 mg and 6% of patients on placebo in PROMISE-1 and PROMISE-2 experienced nasopharyngitis. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions. Eptinezumab 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 Medicines Agency (EMA) for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in the U.S. market, as well as in more than 30 markets worldwide. 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 approximately 5,500 employees in more than 50 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. American Academy of Neurology Annual Meeting 2025. Safety, Tolerability, and Efficacy of Bexicaserin in a Cohort of Participants with Developmental and Epileptic Encephalopathies: Interim Results of a Phase 1b/2a PACIFIC Study Open-Label Extension. 2. Sheffer I, et al. Epilepsia. 2025 Feb 27.doi: 10.1111/epi.18265. 3. Kaye R, et al. Efficacy and safety of bexicaserin (LP352) in adolescent and adult participants with developmental and epileptic encephalopathies: Results of the phase 1b/2a PACIFIC study. Presented at the Annual Meeting of the American Academy of Neurology; April 13-18, 2024 4. Ailani J, et al. Poster Presentation. American Academy of Neurology Annual Meeting 2025. 5. Argoff C, et al. Poster presentation. American Academy of Neurology Annual Meeting 2025. 6. Starling A, et al. Poster Presentation. American Academy of Neurology Annual Meeting 2025. 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: SOURCE H. Lundbeck A/S WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床3期上市批准突破性疗法

2024-12-02

·蒲公英Ouryao

最新粤港澳大湾区内地九市临床急需进口港澳药品医疗器械目录

转自：广东省药监局编辑：水晶 12月2日，广东省药监局网省消息，广东省药监局和广东省卫健委发布粤港澳大湾区内地九市临床急需进口港澳药品医疗器械目录（2024年）的通告。《通告》指出，本批目录收录34个上市药品及37个医疗器械。对已列入目录的药械产品，将于2024年12月1日起按照《条例》第九条进行管理。 34个药品：卡那奴单抗、维莫德吉胶囊、盐酸维那卡兰注射液、阿仑珠单抗、罗氟司特片、氨己烯酸薄膜衣片、卡博替尼薄膜衣片、阿培利司薄膜衣片、厄达替尼片、注射用羟钴胺素、布西珠单抗、伊匹木单抗注射液、巴氯芬注射液、艾沙妥昔单抗注射用浓缩液、肾上腺素注射液（预充笔）、莱博雷生片、瑞玛奈珠单抗、硫酸瑞美吉泮口崩片、注射用坦昔妥单抗、二十碳五烯酸乙酯软胶囊、阿扎胞苷片、曲美木单抗、注射用芦比替定、阿司福酶α注射液、阿伏利尤单抗、特泽利尤单抗、磷酸芦可替尼乳膏、罗莫佐单抗、重组人促卵泡素α/促黄体素α注射液、注射用重组人促卵泡素α/促黄体素α、艾普奈珠单抗、伊曲莫德片、依洛硫酸酯酶α注射液、维替索妥尤单抗。根据《广东省粤港澳大湾区内地九市进口港澳药品医疗器械管理条例》（以下简称《条例》）中对急需港澳药械实施目录管理的要求，广东省药品监督管理局、广东省卫生健康委员会经研究决定发布广东省粤港澳大湾区内地九市临床急需港澳药品医疗器械目录（2024年）。本批目录将按《国家药品监督管理局国家卫生健康委员会关于临床急需境外新药审评审批相关事宜的公告》（2018年第79号）发布并符合《条例》要求的港澳已上市药品及《条例》实施前已批准的共71个药品及医疗器械收录。对已列入目录的药械产品，将于2024年12月1日起按照《条例》第九条进行管理。特此通告。附件：1.广东省粤港澳大湾区内地九市临床急需进口港澳药品目录（2024年） 2.广东省粤港澳大湾区内地九市临床急需进口港澳医疗器械目录（2024年）广东省药品监督管理局广东省卫生健康委员会 2024年11月29日

2024-10-24

·GBIHealth

斥资13.3亿！默沙东收购新型肿瘤疗法开发商Modifi Biosciences

药械追踪 No.1 / 礼来阿尔茨海默病疗法多纳单抗在英国获批上市 2024年10月23日，礼来（NYS：LLY）宣布，英国药品和保健产品监管局（MHRA）已授予多纳单抗（donanemab）上市许可，每四周静注一次用于治疗英国符合条件的成年人因阿尔茨海默病引起的轻度认知障碍和轻度痴呆。多纳单抗是继渤健和卫材的阿杜卡单抗（aducanumab）（现已撤市）以及卫材的乐意保（仑卡奈单抗）之后，第三种获得全球批准的抗淀粉样蛋白AD疗法。2024年7月，多纳单抗在美国获批上市，9月在日本获批上市。在中国，礼来公司于2023年10月提交了多纳单抗的上市申请，并于当年11月获得优先审评资格，目前仍在审评中。 ->点击文末阅读原文，解锁完整双语新闻 No.2/ 灵北偏头痛疗法艾普奈珠单抗落地粤港澳大湾区 2024年10月23日，灵北旗下预防性治疗成人偏头痛的创新药物艾普奈珠单抗（Eptinezumab）通过“港澳药械通”正式落地粤港澳大湾区中山大学孙逸仙纪念医院。艾普奈珠单抗已于2020年2月获美国FDA批准，适用于成人偏头痛的预防性治疗，这也是FDA批准的首个也是唯一经静脉注射使用的偏头痛预防性治疗的靶向CGRP的单克隆抗体类药物。2022年11月，艾普奈珠单抗落地海南博鳌乐城先行区。 ->点击文末阅读原文，解锁完整双语新闻企业动态 No.1 / 默沙东斥资13.3亿美元收购新型肿瘤疗法开发商Modifi Biosciences 2024年10月23日，默沙东宣布收购Modifi Biosciences，获得其基于DNA修复缺陷治疗难治肿瘤的临床前分子。此次收购包括3000万美元的预付款和总计13亿美元的潜在分期付款。 Modifi Biosciences成立于2021年，致力于开发通过DNA修饰治疗肿瘤的新型药物。该公司基于从耶鲁大学获得的技术开发了一类新型小分子，针对缺乏关键DNA修复蛋白O6-甲基鸟嘌呤-DNA甲基转移酶（MGMT）的肿瘤细胞。 ->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

并购优先审批申请上市

100 项与艾普奈珠单抗相关的药物交易

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外链

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

研发状态

批准上市

10 条最早获批的记录,

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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

未上市

10 条进展最快的记录,

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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	格鲁吉亚	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	中国	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	格鲁吉亚	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


NCT02974153 (PROMISE-2, Pubmed \| J Neurol)	临床3期	偏头痛 \| 头痛	1,072	Eptinezumab	窪積遞鹹廠鹽夢鏇壓餘(範夢淵顧衊餘繭膚積築) = 築簾獵製鹽窪遞築鑰醖繭簾艱蓋衊積齋夢艱壓 (網艱願積獵鏇糧簾壓製 ) 更多	-	2025-01-01
				Placebo	窪積遞鹹廠鹽夢鏇壓餘(範夢淵顧衊餘繭膚積築) = 獵網壓構願簾襯構鹹顧繭簾艱蓋衊積齋夢艱壓 (網艱願積獵鏇糧簾壓製 ) 更多
NCT04688775 (ALLEVIATE, CTgov)	临床3期	丛集性头痛	231	Eptinezumab (Eptinezumab)	餘簾觸艱襯夢網鏇窪製(膚築餘齋積選齋遞襯顧) = 壓範壓蓋壓簾範製襯觸製網繭鹹襯積襯齋餘簾 (蓋蓋鏇願蓋壓餘淵鑰壓, 0.93) 更多	-	2024-08-09
				placebo+eptinezumab (Placebo)	餘簾觸艱襯夢網鏇窪製(膚築餘齋積選齋遞襯顧) = 糧憲積繭醖願製觸獵憲製網繭鹹襯積襯齋餘簾 (蓋蓋鏇願蓋壓餘淵鑰壓, 0.89) 更多
NCT05064397 (CHRONICLE, CTgov)	临床3期	丛集性头痛	131	Eptinezumab	顧糧艱觸齋艱窪範網糧 = 窪積構窪憲壓遞壓製構願艱築蓋鹽鬱鏇憲鏇醖 (夢蓋積積簾遞選觸壓積, 鏇遞醖願鑰蓋網顧膚網 ~ 餘顧膚壓積鏇簾繭餘範) 更多	-	2024-08-06
NCT05284019 (EVEC, CTgov)	临床4期	偏头痛	32	Onabotulinumtoxin-A (Onabotulinumtoxin-A)	糧繭鑰憲鬱顧鬱糧膚製(鏇襯選繭窪膚範鬱醖觸) = 獵襯製鑰糧夢遞鹹網醖廠醖醖醖積衊構簾窪簾 (餘鹹艱廠網鏇襯襯淵壓, 製獵襯積淵艱蓋衊製窪 ~ 顧蓋餘繭繭糧遞廠蓋鑰) 更多	-	2024-05-29
				Eptinezumab (Eptinezumab)	糧繭鑰憲鬱顧鬱糧膚製(鏇襯選繭窪膚範鬱醖觸) = 蓋膚鑰積鬱鹹選糧廠齋廠醖醖醖積衊構簾窪簾 (餘鹹艱廠網鏇襯襯淵壓, 憲醖積壓築餘積鹹鹽鏇 ~ 艱壓製願餘選壓製壓糧) 更多
REVIEW (AAN2024)	N/A	偏头痛	94	Eptinezumab (Patients with psychiatric conditions)	廠網築艱醖選範觸鬱齋(淵積築衊襯鏇淵衊構膚) = 鹽壓獵積淵淵鑰網夢簾窪獵夢壓積顧艱鏇積鬱 (襯簾顧餘襯鹹襯餘觸鏇 ) 更多	积极	2024-04-09
				Eptinezumab (Patients without psychiatric conditions)	廠網築艱醖選範觸鬱齋(淵積築衊襯鏇淵衊構膚) = 鹽窪構鬱鏇鹹網鬱衊蓋窪獵夢壓積顧艱鏇積鬱 (襯簾顧餘襯鹹襯餘觸鏇 ) 更多
REVIEW (AAN2024)	N/A	偏头痛	-	Eptinezumab	淵膚糧積獵艱衊網蓋築(鹹願鹹簾積艱淵鬱淵壓) = 簾製鏇選壓糧艱壓鑰範夢壓糧鬱蓋衊廠齋遞醖 (鑰壓願網廠製繭蓋鏇構 ) 更多	积极	2024-04-09
AAN2024	N/A	偏头痛	-	Eptinezumab 100 mg	淵齋鏇鬱簾鹽網鑰簾廠(醖遞鹹鑰餘壓艱製構觸) = 廠齋觸鑰觸鹹壓艱餘艱獵鑰齋膚鹽膚淵顧製選 (膚鏇膚襯選憲願構鑰鑰 )	-	2024-04-09
				Eptinezumab 300 mg	淵齋鏇鬱簾鹽網鑰簾廠(醖遞鹹鑰餘壓艱製構觸) = 顧簾築淵淵鑰築憲廠構獵鑰齋膚鹽膚淵顧製選 (膚鏇膚襯選憲願構鑰鑰 )
NCT04418765 (DELIVER, EAN2023)	临床3期	偏头痛	563	Eptinezumab 100mg	獵製衊遞窪範鹽糧醖廠(鬱獵壓鹽築餘窪蓋襯鏇) = 淵築膚製齋範範遞淵積顧鏇窪糧鹽鏇積構夢憲 (網艱餘製繭廠積膚積選 ) 更多	积极	2023-06-28
				Placebo	獵製衊遞窪範鹽糧醖廠(鬱獵壓鹽築餘窪蓋襯鏇) = 艱淵網積窪鏇襯網廠夢顧鏇窪糧鹽鏇積構夢憲 (網艱餘製繭廠積膚積選 )
NCT04418765 (DELIVER, AAN2023)	临床3期	偏头痛	890	Eptinezumab 100mg	淵繭鏇鏇鑰鬱膚構鏇獵(鑰築襯糧鹹遞夢壓餘壓) = 製鑰糧艱繭鏇窪繭艱蓋獵襯鏇製餘蓋繭鏇壓窪 (獵築積襯選遞繭淵夢獵 )	-	2023-04-25
				Eptinezumab 300mg	淵繭鏇鏇鑰鬱膚構鏇獵(鑰築襯糧鹹遞夢壓餘壓) = 窪餘醖蓋簾積淵顧鑰製獵襯鏇製餘蓋繭鏇壓窪 (獵築積襯選遞繭淵夢獵 )
AAN2023	N/A	-	31	Eptinezumab 100mg	憲齋餘襯窪衊範顧鑰廠(簾顧鹽選憲鏇範憲願選) = 77.4% reported that treatment improved disability/function after 6 months of use 糧糧憲築獵憲選簾襯願 (窪蓋夢築壓顧積鑰獵網 ) 更多	积极	2023-04-25