石家庄瑞美吉泮III期临床试验-一项在女性中探索名为瑞美吉泮的研究药物用于月经性偏头痛间歇性预防的研究

登记号	CTR20251258	试验状态	进行中
申请人联系人	安慧景	首次公示信息日期	2025-04-03
申请人名称	Pfizer Inc./ 辉瑞投资有限公司/ Catalent Pharma Solutions Limited

登记号	CTR20251258
相关登记号	暂无
药物名称	瑞美吉泮
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	月经性偏头痛
试验专业题目	一项在18 至45 岁女性研究参与者中研究瑞美吉泮与安慰剂相比用于月经性偏头痛间歇性预防的有效性和安全性的III 期、双盲、平行组、干预性研究
试验通俗题目	一项在女性中探索名为瑞美吉泮的研究药物用于月经性偏头痛间歇性预防的研究
试验方案编号	C4951063	方案最新版本号	终版方案修正案1
版本日期:	2024-12-05	方案是否为联合用药	否

申请人名称	[["Pfizer Inc."],["辉瑞投资有限公司"],["Catalent Pharma Solutions Limited"]]
联系人姓名	安慧景	联系人座机	010-85161096	联系人手机号	18600820031
联系人Email	huijing.an@pfizer.com	联系人邮政地址	北京市-北京市-北京市东城区朝阳门北大街五矿广场B座9层	联系人邮编	100010

主要目的：确认在每个月经周期给药 7 天时瑞美吉泮75 mg ODT相对于安慰剂用于月经性偏头痛（定义为 5 天 PMP 发生）间歇性预防的优效性。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 45岁(最大年龄)
性别	女
健康受试者	无
入选标准	[["≥18 至 ≤45 岁、月经周期规律（≥24 天且 ≤34 天）且研究者认为根据研究参与者月经史能够可靠（±3 天）预测月经开始日期的女性研究参与者。nt有关女性研究参与者的生殖标准，请参见附录 4。"],["至少 1 年符合第 3 版国际头痛疾病分类 诊断标准的偏头痛史（有或无先兆）：na.t至少 5 次发作，且满足标准 1-3：n1.t（在未接受治疗或未成功治疗的情况下）头痛发作持续 4 至 72 小时n2.t头痛具有以下 4 个特征中的至少 2 个：n 单侧nt搏动性nt强度为中度或重度nt日常体力活动（例如步行或爬楼梯）导致头痛恶化或因头痛回避此类活动n3.t头痛期间至少存在以下一种状况：nt恶心和/或呕吐nt畏光和畏声nb.t其他 ICHD-3 诊断无法更好地解释"],["有至少 3 个月的月经性偏头痛发作史n患者报告以下病史：在筛选前 3 个月经周期的至少 2 个周期中，在 PMP （即月经周期的第 -2 天至第 +3 天，其中第 1 天为月经开始日期）至少经历 1 次偏头痛发作。"],["如果研究参与者正在接受允许的连续背景偏头痛预防性治疗药物（最多一种非 CGRP 治疗），则在筛选访视前药物剂量必须保持稳定至少 3 个月且预计在研究期间剂量不会改变（第 6.9.2.1 节）；将设定随机分组的上限，使接受背景预防治疗者不超过试验人群的 30%。"],["如果在筛选前避孕药的剂量已稳定 ≥2 个月且预计在研究参与期间不会改变，则使用口服避孕药作为避孕方法的女性有资格参与研究。如果已放置宫内节育器（IUD）至少 3 个月，则使用该装置作为避孕方式的女性也有资格参与研究。"]]
排除标准	[["以下任何一种：n在筛选前 3 个月内，每月 PMP 以外的偏头痛日 6 天。n在筛选前 3 个月内，诊断为慢性偏头痛或平均每月头痛日 14 天。n有视网膜型偏头痛、基底型偏头痛或偏瘫型偏头痛的病史。n任何三叉神经自主神经性头痛病史（例如，丛集性头痛、短暂单侧神经痛样头痛发作伴结膜充血和流泪 [SUNCT]、短暂单侧神经痛样头痛发作伴头面部自主神经症状 [SUNA]、持续性偏侧头痛、阵发性偏侧头痛或三叉神经痛）。"],["任何医学或精神状况，包括最近（过去一年内）主动自杀意念/行为或实验室检查异常，可能增加参与研究的风险或（根据研究者判断）可能使研究参与者不适合参加研究：ntPHQ-8 总评分 ≥10nt自杀意念和行为（以下一项或多项都是排除性的）：nt在筛选时对 C-SSRS 第 1 项或第 2 项（过去 30 天内）给出肯定回答；nt在一生中的任何时候曾有具有实际意图、方法或计划的z自杀意念：对 C-SSRS 第 3、4 或 5 项给出肯定回答；nt有自杀行为史：对 C-SSRS 中的任何自杀行为项的回答为“是”。nt目前诊断为精神分裂症、双相情感障碍或边缘型人格障碍。"],["在筛选访视时静息 10 分钟后收缩压 >150 mmHg 或舒张压 >100 mmHg。可以重复一次以确认重现性。"],["研究者认为会干扰研究安全性或有效性评估的其他疼痛综合征（例如，纤维肌痛、复杂性局部疼痛综合征）、重大神经系统疾病（偏头痛除外）或其他医学状况（包括内分泌和妇科疾病，例如每个月经周期通常需要 >3 天 NSAID 治疗的重度痛经）。"],["筛选访视前 12 个月内有酒精或药物滥用史、治疗史或证据，有有任何符合DSM-V 标准 严重物质使用障碍，或者研究参与者药物滥用筛查呈阳性，且研究者认为有医学意义，会影响研究参与者的安全性或研究结果的解读。n此外：nt药物筛查检出可卡因、安非他明和苯环己哌啶（PCP）者须被排除，不允许复检。nt对于安非他明阳性，同时正在接受处方安非他明治疗已获批的适应症（例如，注意力缺陷多动障碍 [ADHD]）的研究参与者，研究者可自行决定允许其入组研究。研究者的这一决定必须妥善记录在研究参与者的原始病历中。兴奋剂的剂量必须自访视 1 前 3 个月（12 周）起保持稳定，直至 OLE或 EoT 访视结束。nt筛选访视前 3 个月（12 周）内每月 >4 天的麻醉剂使用史，如阿片类药物（例如吗啡、可待因、羟考酮、氢可酮）或巴比妥类药物（例如 Butalbital）。nt如果药物筛查检出大麻，根据研究者书面意见，研究参与者不符合DSM-V 物质使用障碍标准，阳性筛查结果不代表存在影响研究参与者安全性或研究结果解读的临床状况，则无需排除研究参与者。研究参与者必须同意在研究期间不使用大麻。n干预的任何成分有超敏反应或其他禁忌症。"],["对研究治疗干预的任何成分有超敏反应或其他禁忌症。"],["当前使用任何禁用伴随用药，或研究参与者不愿意或不能按要求使用伴随用药。"],["之前参加了非生物研究用药物或干预性治疗的临床试验，且其末次研究访视发生在本研究基线访视前 30 天内。之前参加了生物研究用药物的临床试验，且其末次研究访视发生在本研究基线访视前 90 天内。在参加本临床试验的同时参加任何其他研究性临床试验。"],["筛选访视时有以下任何结果：nt体重指数 >35 kg/m2nteGFR（使用 CKD-EPI-Scr-Scys 组合计算）<30 mL/min/1.73 m2nt总胆红素 >1.5 × ULN（在筛选期可以复检一次进行确认；如果怀疑为吉尔伯特综合征，则直接胆红素 >ULN 为排除标准）ntAST（SGOT）或 ALT（SGPT）>2.0 × ULN"],["直接参与研究实施的研究中心工作人员及其家人、以其他方式受研究者监管的研究中心工作人员，以及直接参与本研究实施的申办者和申办者代表员工及其家人。"]]

试验药	[["中文通用名:瑞美吉泮 英文通用名:Rimegepant 商品名称:乐泰可","剂型:口腔崩解片 规格:75mg 用法用量:每个周期的第-3天至第4天每天服用一次瑞美吉泮75mgODT或匹配的安慰剂，每次1片。开放扩展阶段，对于非月经性偏头痛发作的急性治疗，随机分配至瑞美吉泮组的研究参与者可按需服用1片。 用药时程:最多6个月经周期"]] 序号 名称 用法
对照药	[["中文通用名:瑞美吉泮安慰剂 英文通用名:placeboofRimegepant 商品名称:NA","剂型:口腔崩解片 规格:75mg 用法用量:观察阶段从每个周期的第-3天至第4天每天服用一次匹配的安慰剂,每次1片,持续7天,无论其当天是否发生偏头痛.双盲治疗阶段从每个周期的第-3天至第4天每天服用一次瑞美吉泮75mgODT或匹配的安慰剂,每次1片,持续7天,无论其当天是否发生偏头痛 用药时程:最多5个月经周期"]] 序号 名称 用法

主要终点指标及评价时间

[["DBT (双盲治疗) 阶段每个周期中 5 天 PMP 的偏头痛日较 OP 的平均变化","双盲治疗（DBT）阶段","有效性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["关键次要终点:DBT阶段每个周期中5天PMP的头痛日数较 OP 的平均变化;DBT阶段每个周期中5天PMP的偏头痛日较OP减少≥50%的研究参与者百分比(50% 应答者)","双盲治疗（DBT）阶段","有效性指标"],["关键次要终点:DBT阶段每个周期中5天PMP的偏头痛急性治疗药物用药日较OP的平均变化;DBT阶段每个周期中5天PMP的偏头痛特异性急性治疗药物用药日较OP的平均变化(基于eDiary回答)","双盲治疗（DBT）阶段","有效性指标"],["关键次要终点:DBT阶段每个周期中5天PMP的伴中重度失能的偏头痛日较OP的平均变化;DBT 阶段每个周期中5天PMP的中重度头痛日较OP的平均变化","双盲治疗（DBT）阶段","有效性指标"],["关键次要终点:DBT阶段每个周期中5天PMP的中重度偏头痛日较OP的平均变化;DBT阶段每个周期中给药后(即7天给药期后1天)MiCOAS 认知评分较基线的平均变化","双盲治疗（DBT）阶段","有效性指标"],["关键次要终点:DBT阶段每个周期中每月偏头痛日(每个周期,标准化为28天)较OP的平均变化DBT阶段每个周期中每月头痛日(每个周期,标准化为28天)较OP的平均变化","双盲治疗（DBT）阶段","有效性指标"],["关键次要终点:DBT 阶段每个周期中每月偏头痛特异性急性治疗药物用药日（每个周期，标准化为 28 天）较 OP 的平均变化","双盲治疗（DBT）阶段","有效性指标"],["其他次要终点:DBT阶段每个周期中每例研究参与者无偏头痛5天PMP的平均百分比(每例研究参与者DBT阶段的无偏头痛PMP数量/PMP数量)","双盲治疗（DBT）阶段","有效性指标"],["其他次要终点:DBT阶段每个周期中5天PMP的伴相关症状(恶心,呕吐,畏光和/或畏声)的偏头痛日较OP的平均变化;DBT阶段的每个周期中无失能或伴轻度失能的PMP天数的平均百分比","双盲治疗（DBT）阶段","有效性指标"],["其他次要终点:DBT 阶段每个周期末次给药后第二天工作效率和活动障碍问卷 - 偏头痛（WPAI-M）各领域评分较基线的平均变化","双盲治疗（DBT）阶段","有效性指标"],["其他次要终点:DBT阶段每个周期末次给药后第二天偏头痛功能影响问卷(MFIQ)评分较基线的平均变化;DBT阶段每个周期末次给药后第二天和第21天使用用药满意度(SM)量表评估的治疗满意度","双盲治疗（DBT）阶段","有效性指标"],["其他次要终点:DBT阶段每个周期末次给药后第二天评估的过去一周内研究参与者总体印象严重度(PGI-S)量表;DBT 阶段每个周期第21天偏头痛相关生活质量问卷v2.1(MSQv2.1)较基线的平均变化","双盲治疗（DBT）阶段","有效性指标"],["其他次要终点:DBT和OLE阶段发生治疗期间出现的不良事件(TEAE),严重TEAE,导致研究治疗干预终止的TEAE和治疗期间发生3-4级实验室检查异常的研究参与者例数和百分比","双盲治疗（DBT）阶段 和 OLE（开放性扩展） 阶段","安全性指标"],["探索性终点:在每个周期给药后以及整个DBT和OLE阶段评估的痛经症状干扰量表(DSI);每个周期给药后以及整个DBT和OLE阶段的偏头痛临床结局评估系统(MiCOAS)认知评分","双盲治疗（DBT）阶段 和 OLE（开放性扩展） 阶段","有效性指标"],["探索性终点:偏头痛生理功能影响日记（MPFID）在 OLE 阶段中接受急性治疗的头痛日对单项日常活动总体项目的总体影响","OLE（开放性扩展） 阶段","有效性指标"],["探索性终点:每种经治疗的非 PMP 头痛的研究参与者总体印象急性治疗变化（PGI-C）量表，其中变化是 OLE 阶段的特定发作相对于治疗前状态的变化","OLE（开放性扩展） 阶段","有效性指标"],["探索性终点:恢复正常功能，评估方法如下：在 OLE 阶段填写每日 eDiary 时，中重度失能达到峰值的头痛经治疗恢复至 0 分（无失能）","OLE（开放性扩展） 阶段","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	王贺波	学位	博士	职称	主任医师
	电话	13582131890	Email	wanghbhope@sina.com	邮政地址	河北省-石家庄市-和平西路348号
	邮编	050051	单位名称	河北省人民医院

[["河北省人民医院","王贺波","中国","河北省","石家庄市"],["苏州大学附属第一医院","赵红如","中国","江苏省","苏州市"],["南京医科大学第二附属医院","吴晋","中国","江苏省","南京市"],["延安大学咸阳医院","郭爱红","中国","陕西省","咸阳市"],["复旦大学附属华山医院","虞培敏","中国","上海市","上海市"],["陕西省人民医院（含西咸院区）","郭晓敏","中国","陕西省","西安市"],["康复大学青岛中心医院（青岛市中心医院）","王岭","中国","山东省","青岛市"],["重庆医科大学附属第一医院","谭戈","中国","重庆市","重庆市"],["北京大学人民医院（北京大学第二临床医学院）","郭淮莲","中国","北京市","北京市"],["上海市东方医院","左联","中国","上海市","上海市"],["St. Charles Clinical Research","Hepner, Seth","美国","MISSOURI","Weldon Spring"],["Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso","Sacco, Simona","意大利","ABRUZZO","L`Aquila"],["McGill Family Practice","McGill, Lorrie","美国","NEBRASKA","Papillion"],["Medical Care and Research SA de CV","Gien Lopez, Jose Antonio","墨西哥","YUCATAN","Merida"],["Fondazione Istituto Neurologico C. Mondino","Tassorelli, Cristina","意大利","PAVIA","Pavia"],["Azienda Ospedaliera Universitaria Careggi","Chiarugi, Alberto","意大利","TOSCANA","Firenze"],["Neurologie Berlin","Brinckmann, Marie Perle","德国","NA","Berlin"],["Jefferson Headache Center","Marmura, Michael James","美国","PENNSYLVANIA","Philadelphia"],["Rochester Clinical Research, LLC","Davis, Matthew Gilruth","美国","NEW YORK","Rochester"],["Diablo Clinical Research, Inc.","Stacey, Helen L","美国","CALIFORNIA","Walnut Creek"],["Michigan Headache & Neurological Institute","Saper, Joel R.","美国","MICHIGAN","Ann Arbor"],["Mayo Clinic in Arizona – Scottsdale","Halker Singh, Rashmi","美国","ARIZONA","Scottsdale"],["MALLIKATTA NEURO CENTRE","Nellikunja, Shankara","印度","KARNATAKA","Mangalore"],["Mautalen Salud e Investigacion","Saravia, Bibiana","阿根廷","CIUDAD AUTONOMA DE BUENOS AIRES","Buenos Aires"],["Aggarwal and Associates Limited","Aggarwal, Naresh Kumar","加拿大","ONTARIO","brampton"],["Rigshospitalet, Glostrup","Ashina, Messoud","丹麦","NA","Glostrup"],["Charlottesville Medical Research","Clark, James R.","美国","VA","Charlottesville"],["Severance Hospital, Yonsei University Health System","Chu, Min Kyung","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Hospital Clínico Universitario de Valladolid","Guerrero Peral, ángel Luis","西班牙","CASTILLA Y LEóN","Valladolid"],["Silmedic","Palka-Kisielowska, Ilona","波兰","SLASKIE","Katowice"],["Instytut Zdrowia Dr Boczarska Jedynak","Boczarska-Jedynak, Magdalena","波兰","MALOPOLSKIE","Oswiecim"],["Hospital Universitario La Paz","Díaz de Terán, Javier","西班牙","MADRID","Madrid"],["Hospital Clinic De Barcelona","Obach, Víctor","西班牙","NA","Barcelona"],["Private Practice - Dr. Anna Szczepańska-Szerej","Szczepanska-Szerej, Anna Magdalena","波兰","LUBELSKIE","Lublin"],["Specjalistyczny Gabinety","Banach, Marta","波兰","MALOPOLSKIE","Krakow"],["CaRe Clinic","Badenhorst, Josias Servaas","加拿大","ALBERTA","Red Deer"],["Bluewater Clinical Research Group Inc.","O'Mahony, John Charles","加拿大","ONTARIO","Sarnia"],["Hallym University Dongtan Sacred Heart Hospital","Cho, Soo Jin","韩国","KYǒNGGI-DO","Hwaseung"],["Kangbuk Samsung Hospital","Moon, Heui Soo","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Wellcome Foundation Building","Goadsby, Peter","英国","LONDON, CITY OF","London"],["IDIM","Pagani Cassará, Fátima","阿根廷","CIUDAD AUTóNOMA DE BUENOS AIRES","Ciudad Autónoma de Buenos Aires"],["University of Toronto - Womens College Hospital WCH - Centre for Headache","Lay, Christine","加拿大","ONTARIO","Toronto"],["Instituto de Investigación Médica Mercedes y Martín Ferreyra","Lisicki, Marco","阿根廷","NA","Cordoba"],["Clinstile, S.A. de C.V.","Quinones Aguilar, Sandra","墨西哥","DISTRITO FEDERAL","Ciudad de México"],["Marengo CIMS Hospital","Sharma, Dr. Mukesh","印度","GUJARAT","Ahmedabad"],["Sendai Headache and Neurology Clinic","Matsumori, Yasuhiko","日本","MIYAGI","Sendai"],["Konan Medical Center","Kitamura, Shigekazu","日本","HYOGO","Kobe"],["Tanaka Neurosurgical Clinic","Tanaka, Shigeya","日本","KAGOSHIMA","Kagoshima"],["MIGRE Polskie Centrum Leczenia Migreny","GRYGLAS-DWORAK, ANNA","波兰","DOLNOSLASKIE","Wroclaw"],["Instituto Biomedico de Investigacion","Reyes, Sarug","墨西哥","AGUASCALIENTES","Aguascalientes"],["Canisius-Wilhelmina Ziekenhuis","Leen, Willemijn","荷兰","GELDERLAND","Nijmegen"],["Ospedale Bellaria- Azienda USL di Bologna","Sabina, Cevoli","意大利","NA","Bologna"],["Dr Sekowska Klinika Leczenia Bólu","Sekowska, Agnieszka","波兰","NA","Warszawa"],["Leiden University Medical Center","Terwindt, Gisela M.","荷兰","ZUID-HOLLAND","Leiden"],["IRCCS San Raffaele Pisana","Barbanti, Piero","意大利","ROMA","Rome"],["Clinical Research Institute S.C.","ORTA, DANIEL SAN JUAN","墨西哥","MéXICO","State of Mexico"],["Synexus Clinical Research GmbH Synexus Frankfurt Clinical Research Centre","berfelo, florieke","德国","HESSEN","Frankfurt am Main"],["MediSphere Medical Research Center, LLC","Reyes, Hubert S.","美国","INDIANA","Evansville"],["Velocity Clinical Research, Hallandale Beach","Safirstein, Beth Emmie","美国","FLORIDA","Hallandale Beach"],["Fondazione Policlinico Universitario Campus Bio-Medico","Vernieri, Fabrizio","意大利","LAZIO","Rome"],["Urban Family Practice Associates","Davis, Cedrice Nichole","美国","GA","Marietta"],["A.O.U.C. Policlinico di Bari","Prudenzano, Maria Pia","意大利","BA","Bari"],["Hospital Comarcal General de Elda de Virgen de la Salud","Medrano Martinez, Vicente","西班牙","ALICANTE","Elda"],["Ewha Womans University Seoul Hospital","Song, Tae-Jin","韩国","NA","Gangseo"],["CLINVEST HEADLANDS LLC","True, David Gregory","美国","MISSOURI","Springfield"],["Omega Medical Research","Fried, David L.","美国","RHODE ISLAND","East Greenwich"],["Royal Columbian Hospital","Medvedev, George","加拿大","BRITISH COLUMBIA","New Westminster"],["Emovis GmbH","Hahn, Peter Klaus","德国","BERLIN","Berlin"],["Region Midtjylland, Regionshospitalet Viborg","Pluss, Lis Gregoretti","丹麦","NA","Viborg"],["Hospital Clínico Universitario Lozano Blesa","santos, sonia","西班牙","ARAGóN","Zaragoza"],["Seoul National University Hospital","Lee, Mi Ji","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Korea University Guro Hospital","Oh, Kyungmi","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Sanjay Gandhi Post Graduate Institute of Medical Sciences","Kalita, Jayantee","印度","NA","Lucknow"],["Hospital Cordoba","Liwacki, Susana del Valle","阿根廷","CóRDOBA","Córdoba"],["FLENI","Goicochea, Maria","阿根廷","NA","Buenos Aires"],["Nagaseki Headache Clinic","Nagaseki, Yoshishige","日本","YAMANASHI","Kai"],["Tatsuoka Neurology Clinic","Tatsuoka, Yoshihisa","日本","KYOTO","Kyoto"],["Tokyo Headache Clinic","Shimizu, Kazutaka","日本","TOKYO","Shibuya-ku"],["Montefiore Hospital","Pavlovic, Jelena","美国","NEW YORK","Bronx"],["Centre de Recherche Saint-Louis","Bouchard, Manon","加拿大","QUEBEC","Lévis"],["Centricity Research Halifax Multispecialty","Schoffer, Kerrie","加拿大","NOVA SCOTIA","Halifax"],["Centro de Investigaciones Médicas Tucuman","JOSE, JORGE GUSTAVO","阿根廷","TUCUMáN","San Miguel de Tucumán"],["AO Santa Maria della Misericordia","Sarchielli, Paola","意大利","PERUGIA","Perugia"],["Radhakrishna Multispecialty Hospital & IVF Centre","Bhat, Vidya V","印度","KARNATAKA","Bangalore"],["Topiwala National Medical College & B. Y. L. Nair Charitable Hospital","Chakor, Rahul","印度","MAHARASHTRA","Mumbai"],["Charité Universitatsmedizin Berlin","Raffaelli, Bianca","德国","BERLIN","Berlin"],["Lalitha Super Speciality Hospital","Pamidimukkala, Vijaya","印度","ANDHRA PRADESH","Guntur"],["Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute","Yeole, Amit","印度","NA","Nashik"],["Jawaharlal Nehru Medical College, Ajmer","Nagrawal, Dilip","印度","RAJASTHAN","Kala Bagh"],["Klinische forschung Schwerin GmbH","Paschen, Christine","德国","MECKLENBURG-VORPOMMERN","Schwerin"],["Private Practice - Dr. Jacek Rozniecki","Rozniecki, Jacek Jerzy","波兰","LóDZKIE","Lodz"],["Getwell Hospital & Research Institute","Shembalkar, Prafulla Keshaorao","印度","MAHARASHTRA","Nagpur"],["Ospedale San Raffaele","Filippi, Massimo","意大利","MILANO","Milano"],["Isala, locatie Zwolle","Liebregt-Zwartbol, Rachel","荷兰","NA","Zwolle"],["Hospital Universitario Marqués de Valdecilla","Pascual, Julio","西班牙","CANTABRIA","Santander"],["Nowon Eulji Medical Center, Eulji University,","Kim, Byung-Kun","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["MedStar Georgetown University Hospital","Tinsley, Amanda","美国","VIRGINIA","McLean"],["HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO","Gonzalez oria, Carmen","西班牙","SEVILLA","Sevilla"],["West Walk Surgery","Davies, Sam","英国","BRISTOL, CITY OF","Yate"],["Panthera Biopartners Glasgow","Goodfellow, John","英国","NA","Glasgow"],["Re:Cognition Health - Birmingham","McLoughlin, Terence","英国","ENGLAND","Birmingham"],["St Luke`s Meridian Medical Center","Smith, Ryan","美国","IDAHO","Meridian"],["NZOZ Neuromed M.i M. Nastaj","Nastaj, Marcin","波兰","LUBELSKIE","Lublin"],["Hope Clinical Research, Inc.","Aazami, Hessam","美国","CALIFORNIA","Canoga Park"],["Hospital Universitario La Princesa","Gago Veiga, Ana Beatriz","西班牙","MADRID","MADRID"],["Metrodora Institute","Hindiyeh, Nada","美国","UTAH","West Valley City"],["VIN-Julie Schwartzbard","Schwartzbard, Julie","美国","FLORIDA","Aventura"],["A.O.U. Città della salute e della scienza di torino","Marozio, Luca","意大利","PIEMONTE","Torino"],["Carolina Women`s Research and Wellness Center","Lukes, Andrea S.","美国","NORTH CAROLINA","Durham"],["Phylasis Clinicas Research","Gudino, Manuel","墨西哥","MEXICO","Cuautitlan, Izcalli Estado de Mexico"],["OCT Research ULC","Maytham, Colleen","加拿大","BRITISH COLUMBIA","Kelowna"],["FutureMeds Warszawa Centrum","Otak, Bartosz Dariusz","波兰","MAZOWIECKIE","Warszawa"],["Alliance for Multispecialty Research, LLC","Punch, Jerry L.","美国","TENNESSEE","Knoxville"],["Axiom Research","Anderson, Dennis","美国","CALIFORNIA","Colton"],["Excel Clinical Research, LLC","Anderson, Duane Claude","美国","NEVADA","Las Vegas"],["FutureSearch Trials of Neurology","Hudson, John Douglas","美国","TEXAS","Austin"],["Operadora Unidad de Investigacion en Salud","Martinez Manzanera, Carlos Andres","墨西哥","CHIHUAHUA","Chihuahua"],["Clinical Research Atlanta","Finley, Jon","美国","GEORGIA","Stockbridge"],["Jacksonville Center for Clinical Research","Toenjes, Steven A","美国","FL","Jacksonville"],["Bioluminux","Oyesile, Babatunde","英国","BUCKINGHAMSHIRE","Milton Keynes"],["Hull Royal Infirmary","Ahmed, Fayyaz","英国","EAST RIDING OF YORKSHIRE","Hull"],["FutureMeds - Cadiz","Pardo Moreno, Francisco Javier","西班牙","CADIZ","Chiclana de la Frontera"],["Clinical Research of Philadelphia","Andruczyk, Eugene","美国","PENNSYLVANIA","Philadelphia"],["Centro de Investigación Médico Biológica y Terapia Avanzada","Partida Medina, Luis Roberto","墨西哥","JALISCO","Guadalajara"],["Re:Cognition Health - London","MacSweeney, Josephine Emer","英国","WESTMINSTER","London"],["The Walton Centre","Ghadiri-Sani, Mona Walton Centre","英国","LIVERPOOL","Liverpool"],["CUMC - Columbia Doctors","Fryer, Robert","美国","NEW YORK","New York"],["Panthera Biopartners - Sheffield","Collins, Hannah Louise","英国","SHEFFIELD","Sheffield"],["Panthera Clinic - York","Wickens, Olivia","英国","UNITED KINGDOM","Rochdale"],["Panthera Biopartners – Manchester","Freitas, Henrique","英国","ENGLAND","Rochdale"],["Synexus Manchester Clinical Research Centre","Viljoen, Marianne Elizabeth","英国","GREAT BRITAIN","Manchester"],["Texas Neurology, PA","Herzog, Steven P.","美国","TX","Dallas"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["河北省人民医院医学伦理委员会","同意","2025-01-03"],["河北省人民医院医学伦理委员会","同意","2025-02-08"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 48 ； 国际: 480 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：2025-03-11；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；