北京硫酸瑞美吉泮口崩片III期临床试验-一项在慢性偏头痛青少年患者中评价研究药物Rimegepant的研究

登记号	CTR20251641	试验状态	进行中
申请人联系人	安慧景	首次公示信息日期	2025-04-25
申请人名称	Pfizer Inc./ 辉瑞投资有限公司/ Catalent Pharma Solutions Limited

登记号	CTR20251641
相关登记号	暂无
药物名称	硫酸瑞美吉泮口崩片
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	12至＜18岁青少年慢性偏头痛的预防治疗
试验专业题目	一项评价Rimegepant 在12 至
试验通俗题目	一项在慢性偏头痛青少年患者中评价研究药物Rimegepant的研究
试验方案编号	C4951013	方案最新版本号	最终方案修正案3
版本日期:	2024-11-19	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-东城区朝阳门北大街3号五矿广场B座9层	联系人邮编	100010

主要目的：比较 Rimegepant 与安慰剂用于青少年慢性偏头痛预防性治疗的有效性。

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	12岁(最小年龄)至 18岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["研究参与者在签署知情同意书时年龄为12 至<18 岁。研究参与者在随机化（基线）访视时或之前不得年满18 岁。"],["研究参与者有至少6 个月的偏头痛史（有或无先兆），符合国际头痛疾病分类第3 版的诊断标准，包括以下内容：n筛选访视前3 个月内，每月头痛日达到15 天或以上。n筛选访视前3 个月内，每月偏头痛日达到8 天或以上。nOP 期间头痛日达到15 天或以上。nOP 期间偏头痛日达到8 天或以上。n具有区分偏头痛发作与紧张性/丛集性或其他类型头痛的能力；n在不接受治疗的情况下，偏头痛发作的平均持续时间为4 至72 小时。"],["签署书面知情同意：n研究参与者能够理解知情告知文件（IAD），且研究参与者的父母/法定代表（根据当地法规）能够阅读并理解知情同意文件（ICD）。n在进行任何研究特定程序之前，研究参与者已签署IAD/ICD（根据当地法规），且研究参与者的父母/法定代表已签署ICD。n研究参与者必须能够阅读并理解书面说明，且愿意在法定代表的监督下按照方案要求完成所有问卷。"]]
排除标准	[["排除目标疾病：n筛选访视前1 个月内存在持续偏头痛（定义为持续头痛）。n研究参与者非典型偏头痛类型、偏头痛并发症，或混杂具有临床意义的疼痛综合征，经PI 评估可能干扰研究参与者参加本研究能力。"],["研究参与者任何医学或实验室检查异常，包括任何有临床意义的超出范围的生命体征（肝肾功能和心脏评价的关键参数评估见排除标准#10），可能增加参与研究的风险或经研究者判断使研究参与者不适合参加研究。"],["未受控制和/或未治疗的任何当前精神疾病。"],["筛选前30 天的C-SSRS 任何回答为“是”。"],["筛选前6 个月内酒精滥用和/或非法药物使用史符合DSM-5&reg;中物质滥用诊断标准（不包括尼古丁和咖啡因）。n对于药物滥用筛查结果呈阳性且正在接受针对已获批适应症（例如ADHD）的处方药的患者，研究者可自行决定是否可入组研究。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。兴奋剂的剂量必须从基线前3 个月至治疗结束访视期间保持稳定。"],["过敏和药物不良反应：n重度药物过敏史（例如速发严重过敏反应，或者已知对Rimegepant 或其辅料过敏或不耐受）。"],["当前正在使用任何禁用的伴随用药。"],["用于偏头痛预防性治疗的药物超过1 种。n筛选访视前6 个月内伴随使用CGRP 受体拮抗剂（例如Nurtec&trade; 或其他）和单克隆抗体（例如Erenumab、Fremanezumab 或其他）。n在筛选访视前停用预防性治疗偏头痛的药物不足30 天。n在OP 前至少3 个月（12 周）内预防性治疗偏头痛的药物剂量不稳定，或预期在研究过程中剂量会发生改变。"],["在本研究所用的研究药物首次给药前30 天（或根据当地要求确定）或5 个半衰期内（以时间较长者为准）接受过其他研究用药品（药物或疫苗）给药。n在参加本研究期间的任何时间参加其他干预性治疗研究的研究参与者也将排除。"],["筛选期间，将排除以下实验室/ECG 值：neGFR/CrCl <45 mL/min/1.73 m2.n血清总胆红素> ULN（除非研究参与者已知患有或疑似患有Gilbert 综合征）。nAST 或ALT >2×ULN（在筛选期可以重复测量一次AST 和/或ALT，以评估是否符合入组资格）。n基于研究者对中心判读描述的评估，筛选访视时出现了具有临床意义的异常ECG。将根据Fridericia 校正公式确定QT 间期的合格性，其中QTcF= QT/（RR0.33）。"],["OP 期间完成eDiary 报告少于24 天。"],["排除家庭关系：n已经或将要参加本试验的研究参与者的兄弟姐妹或同一家庭成员。n直接参与研究实施的研究中心工作人员及其家庭成员、受研究者监管的其他研究中心工作人员、直接参与研究实施的申办方和申办方代表员工及其家庭成员。"]]

试验药	[["中文通用名:硫酸瑞美吉泮口崩片 英文通用名:rimegepantsulfateorallydisintegratingtablets 商品名称:乐泰可","剂型:口崩片 规格:75mg/片 用法用量:口服，每隔一个日历日服用1片 用药时程:64周"]] 序号 名称 用法
对照药	[["中文通用名:安慰剂 英文通用名:placebo 商品名称:NA","剂型:口崩片 规格:0mg/片 用法用量:口服，每隔一个日历日服用1片 用药时程:64周"]] 序号 名称 用法

主要终点指标及评价时间

[["整个DBT 阶段（第1-12 周）每月偏头痛日较OP 的均值变化。","第1-12 周","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

[["在整个DBT 阶段（第 1-12 周），每月偏头痛特异性急性期治疗药物用药天数较OP 的均值变化。","第 1-12 周","有效性指标"],["在整个DBT 阶段（第1-12 周），每月中度或重度头痛日较OP 的均值变化。","第 1-12 周","有效性指标"],["在整个DBT 阶段（第1-12 周），每月中度或重度偏头痛日较OP 减少≥50% 的研究参与者百分比。","第 1-12 周","有效性指标"],["在DBT 阶段第12 周，PedsQLTM 4.0 通用核心量表总分较基线的均值变化。","第 12 周","有效性指标"],["在每个月和整个DBT阶段，每月急性头痛用药天数和每月急性偏头痛特定用药天数较OP的均值变化。","每个月和整个DBT阶段","有效性指标"],["DBT 和OLE 阶段发生AE、SAE、导致研究药物终止的AE 和治疗期间发生3-4 级实验室检查异常的研究参与者人数和百分比。","DBT 和OLE 阶段","安全性指标"],["在DBT 和OLE 阶段发生导致研究药物终止的肝脏相关AE 和肝脏相关AE 的研究参与者人数和百分比。","DBT 和OLE 阶段","安全性指标"],["在DBT 阶段第12 周，PedMIDAS 总分较基线的均值变化。","第12 周","有效性指标"],["在每个月和整个DBT阶段按疼痛严重程度列出的每月头痛日和偏头痛日较OP的均值变化及减少≥50%,75%和100%的百分比.在DBT阶段前4周的每周按疼痛严重程度列出的每周偏头痛日和头痛日较OP均值变化","每个月和整个DBT阶段","有效性指标"],["在每个月和整个OLE阶段，每月急性头痛用药天数和每月急性偏头痛特定用药天数较OP的均值变化。","每个月和整个OLE阶段","有效性指标"],["在每个月和整个OLE阶段按疼痛严重程度列出的每月偏头痛日和头痛日较OP的均值变化.在每个月和整个OLE阶段,按疼痛严重程度列出的每月偏头痛和头痛日较OP减少≥50%,≥75%和100%的百分比","每个月和整个OLE阶段","有效性指标"],["在OLE 阶段第24 和64 周，PedsQL 总分和PedMIDAS 总分较基线的均值变化。","OLE 阶段","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	郭淮莲	学位	医学博士	职称	主任医师
	电话	13661327709	Email	guohuailian@sina.com	邮政地址	北京市-北京市-西城区西直门南大街11号
	邮编	100044	单位名称	北京大学人民医院（北京大学第二临床医学院）

[["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"],["宁夏医科大学总医院","张庆","中国","宁夏回族自治区","银川市"],["广州市第一人民医院(广州消化疾病中心、广州医科大学附属市一人民医院、华南理工大学附属第二医院)","王小娟","中国","广东省","广州市"],["中南大学湘雅二医院","张洁","中国","湖南省","长沙市"],["中南大学湘雅三医院","张如旭","中国","湖南省","长沙市"],["河北医科大学第二医院","王秀霞","中国","河北省","石家庄市"],["武汉儿童医院（武汉市妇女儿童医疗保健中心、武汉市妇幼保健院、华中科技大学同济医学院附属武汉儿童医院）","孙丹","中国","湖北省","武汉市"],["重庆医科大学附属第一医院","谭戈","中国","重庆市","重庆市"],["中国科学技术大学附属第一医院（安徽省立医院）","程昭昭","中国","安徽省","合肥市"],["苏州大学附属第一医院","赵红如","中国","江苏省","苏州市"],["无锡市儿童医院","华颖","中国","江苏省","无锡市"],["荆州市第一人民医院（荆州市肿瘤医院、长江大学附属第一医院）","杨涛","中国","湖北省","荆州市"],["江苏大学附属医院","于明","中国","江苏省","镇江市"],["上海市儿童医院","王四美","中国","上海市","上海市"],["Wasatch Clinical Research, LLC","Larsen, David C","美国","UTAH","Salt Lake City"],["MIGRE Polish Migraine Center","GRYGLAS-DWORAK, ANNA","波兰","DOLNOSLASKIE","Wroclaw"],["Medicinske centrum Konzilium","Perichtova, Magdalena","斯洛伐克","TRENCIANSKY KRAJ","Dubnica nad Vahom"],["CLINVEST HEADLANDS LLC","Duda, Ralph Joseph","美国","MISSOURI","Springfield"],["Clinica Universidad De Navarra","Irimia Sieira, Pablo","西班牙","NAVARRA, COMUNIDAD FORAL DE","Pamplona"],["CHUVI- Hospital Alvaro Cunqueiro","Blanco Barca, Manuel Oscar","西班牙","(空)","Vigo"],["IN MEDIC s.r.o.","Chamilova, Jana","斯洛伐克","PRESOVSKY KRAJ","Bardejov"],["MUDr. Katarina Mojzisova, Detsky neurolog s. r. o., Ambulancia pediatrickej neurologie","Mojzisova, Katarina","斯洛伐克","BRATISLAVSKY KRAJ","Bratislava"],["Sir Ganga Ram Hospital","Anshu, Rohtagi","印度","DELHI","New Delhi"],["Artemis Hospitals","Singh, Sumit","印度","HARYANA","city"],["Fortis Memorial Research Institute","Gupta, Praveen","印度","HARYANA","Gurugram"],["Hospital Universitari Vall d`Hebron","Pozo-Rosich, Patricia","西班牙","CATALUNYA [CATALUNA]","Barcelona"],["Turku University Hospital","Lahdesmaki, Tuire","芬兰","VARSINAIS-SUOMI","Turku"],["University of Texas Health Science Center at Houston","Koenig, Mary Kay","美国","TEXAS","HOUSTON"],["The Regents of the University of California - Los Angeles (UCLA Pediatrics)","Choe, Meeryo","美国","CALIFORNIA","Los Angeles"],["Avera Research Institute - Sioux Falls","Taylor, Connie","美国","SOUTH DAKOTA","Sioux Falls"],["Terveystalo Tampere","sumelahti, marja-liisa Marja_Liisa","芬兰","PIRKANMAA","Tampere"],["HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO","Gonzalez oria, Carmen","西班牙","SEVILLA","Sevilla"],["Hospital Universitari i Politecnic La Fe","DIAZ INSA, Samuel","西班牙","VALENCIA","Valencia"],["Tominaga Clinic","Takeshima, Takao","日本","OSAKA","Osaka-shi"],["Univerzitna nemocnica Martin","Suroviakova, Stanislava","斯洛伐克","ZILINSKY KRAJ","Martin"],["HCUV","Guerrero Peral, Angel Luis","西班牙","CASTILLA Y LEON","Valladolid"],["Michigan Headache & Neurological Institute","Saper, Joel R.","美国","MICHIGAN","Ann Arbor"],["MALLIKATTA NEURO CENTRE","Nellikunja, Shankara","印度","KARNATAKA","Mangalore"],["Children`s Hospital Colorado","Yonker, Marcy","美国","COLORADO","Aurora"],["Yamaguchi Clinic","Yamaguchi, Yoji","日本","HYOGO","Nishinomiya-shi"],["Tokyo Headache Clinic","Shimizu, Kazutaka","日本","TOKYO","Shibuya-ku"],["Tennoji Department of Neurosurgery","yamada, dai","日本","OSAKA","Abeno-ku Osaka-shi"],["Irccs san raffaele, Roma","Barbanti, Piero","意大利","LAZIO","Roma"],["ASST SPEDALI CIVILI DI BRESCIA","Rao, Renata","意大利","LOMBARDIA","Brescia"],["Nagaseki Headache Clinic","Nagaseki, Yoshishige","日本","YAMANASHI","Kai"],["Tanaka Neurosurgery&Headache Clinic","Tanaka, Shigeya","日本","KAGOSHIMA","Kagoshima"],["University Of Alberta Hospital","Rajapakse, Thilinie","加拿大","ALBERTA","Edmonton"],["Feinberg School of Medicine Northwestern University","Kelley, Anisa","美国","ILLINOIS","Chicago"],["AOU Policlinico Umberto I/ dipartimento materno infantile - scienze uroginecologiche","Spalice, Alberto","意大利","LAZIO","Roma"],["CaRe Clinic","Badenhorst, Josias Servaas","加拿大","ALBERTA","Red Deer"],["Children's Hospital, London Health Sciences Center, Western University","Lagman-Bartolome, Ana Marissa","加拿大","ONTARIO","London"],["Narodny Ustav Detskych Chorob","Mikloskova, Marta","斯洛伐克","BRATISLAVSKY KRAJ","Bratislava III"],["WIP Warsaw IBD Point Profesor Kierkus","Kempisty, Agnieszka","波兰","MAZOWIECKIE","Warsaw"],["Terveystalo Pulssi","Nissila, Markku","芬兰","VARSINAIS-SUOMI","Turku"],["Hospital Universitario HM sanchinarro","Merinero, Alejandro Barroso","西班牙","MADRID, COMUNIDAD DE","Madrid"],["New Children's Hospital","Immonen, Tuuli","芬兰","UUSIMAA","Helsinki"],["Konan Medical Center","Kitamura, Shigekazu","日本","HYOGO","Kobe"],["Specjalistyczne Gabinety Sp. z o.o.","Horodecka-Wardega, Lucyna","波兰","(空)","Krakow"],["Children`s National Medical Center","DiSabella, Marc","美国","DISTRICT OF COLUMBIA","Washington"],["JSS HOSPITAL , MYSORE","Sundaramurthy, Harsha","印度","KARNATAKA","MYSORE"],["Cincinnati Children`s Hospital Medical Center","Hershey, Andrew Dean","美国","OHIO","Montgomery"],["Semmelweis Egyetem","Farkas, Mark Kristof","匈牙利","BUDAPEST","Budapest"],["Nicklaus Children`s Hospital","Heredia Nunez, Wilson","美国","FLORIDA","Miami"],["Ambulatorio Cefalee I.C.O.T. Universita La Sapienza","Di Lorenzo, Cherubino","意大利","LATINA","Latina"],["IRCCS Istituto Neurologico Carlo Besta","Grazzi, Licia","意大利","LOMBARDIA","Milano"],["Ospedale San Paolo Bari","Sciruicchio, Vittorio","意大利","BARI","Bari"],["Duke Health","Werner, Klaus Georg","美国","NC","Durham"],["Weill Cornell Medicine","Ergonul, Zuhal","美国","NEW YORK","New York"],["Robert Wood Johnson University Hospital","Spinner, Amanda","美国","NEW JERSEY","New Brunswick"],["MedicArt Sp. z o. o.","Dubik-Jezierzanska, Marta Olga","波兰","DOLNOSLASKIE","Wroclaw"],["Faculty Hospital Ostrava","Medricka, Hana","捷克共和国","MORAVSKOSLEZSKY KRAJ","Ostrava"],["Dr. Kenessey Albert Korhaz","Bauer, Viktor","匈牙利","NOGRAD","Balassagyarmat"],["University of Texas at Austin, Dell Children's Medical Center","Pavitt, Sara","美国","TEXAS","Austin"],["UPMC Children's Hospital of Pittsburgh","Cobb-Pitstick, Katherine","美国","PENNSYLVANIA","Pittsburgh"],["Neurosphera","Zwolinska, Beata","波兰","MAZOWIECKIE","Warszawa"],["FN Hradec Kralove","Dostal, Ondrej","捷克共和国","HRADEC KRALOVE","Hradec Kralove"],["Fakultni nemocnice v Motole","Kudr, Martin","捷克共和国","PRAHA 5","Praha"],["Detska fakultna nemocnica s poliklinikou Banska Bystrica","Okalova, Katarina","斯洛伐克","BANSKOBYSTRICKY KRAJ","Banska Bystrica"],["Fondazione Istituto Neurologico C. Mondino","Borgatti, Renato","意大利","LOMBARDIA","Pavia"],["Seattle Children's Hospital","Blume, Heidi","美国","WASHINGTON","Seattle"],["Obudai Egeszsegugyi Centrum","Szabo, Gyongyi","匈牙利","BUDAPEST","Budapest"],["Atrium Health Wake Forest Baptist","Nye, Barbara","美国","NORTH CAROLINA","Winston-Salem"],["Fakultni Thomayerova nemocnice","Borilova, Petra","捷克共和国","PRAHA 4","Praha 4"],["Debreceni Egyetem Klinikai Kozpont","Bessenyei, Monika","匈牙利","HAJDU-BIHAR","Debrecen"],["Detska nemocnice FN Brno","Danhofer, Pavlina","捷克共和国","JIHOMORAVSKY KRAJ","Brno"],["Nagykanizsai Kanizsai Dorottya Korhaz","Rada, Eva Kobrane","匈牙利","ZALA","Nagykanizsa"],["Cleveland Clinic","TOURLAS, KONSTANTINOS","美国","OHIO","Cleveland"],["Athleticomed sp z oo","Nowaczewska, Magdalena","波兰","KUJAWSKO-POMORSKIE","Bydgoszcz"],["Oulun yliopistollinen sairaala","Karppa, Mikko","芬兰","POHJOIS-POHJANMAA","Oulu"],["Tampereen yliopistollinen sairaala","Raisio, Mikael Juhana","芬兰","PIRKANMAA","Tampere"],["Kuopio University Hospital, KUH","Kirjavainen, Jarkko","芬兰","POHJOIS-SAVO","Kuopio"],["Centrum Medyczne Hope Clinic","Szklener, Sebastian","波兰","LUBELSKIE","Lublin"],["Universita degli Studi dell'Aquila","Pistoia, Francesca","意大利","L'AQUILA","L'Aquila"],["Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute","Yeole, Amit","印度","(空)","Nashik"],["Rady Children`s Hospital","Frederick, Aliya","美国","CALIFORNIA","San Diego"],["Accellacare - Piedmont","Rashley, Elizabeth","美国","NORTH CAROLINA","Statesville"],["core healthcare group","Badar, Francisco L.","美国","CALIFORNIA","Cerritos"],["Hospital General Universitario de Elda - Hospital Virgen de la Salud","Medrano Martinez, Vicente","西班牙","ALICANTE","Elda"],["OnSite Clinical Solutions","Nahouraii, Robert Ataollah","美国","SOUTH CAROLINA","Charlotte"],["Perseverance Research Center","block, allan","美国","ARIZONA","Scottsdale"],["Hunterdon Neurology","Pandya, Dipakkumar P.","美国","NEW JERSEY","Clinton Township"],["All 印度 Institute of Medical Sciences","Gulati, Sheffali","印度","DELHI","New Delhi"],["Hornooravska nemocnica s poliklinikou Trstena","Tabacakova, Katarina","斯洛伐克","(空)","Trstena"],["NZOZ Neuromed M.i M. Nastaj","Nastaj, Marcin","波兰","LUBELSKIE","Lublin"],["Klinika Leczenia Bolu","Pojmanska, Agnieszka","波兰","MAZOWIECKIE","Warszawa"],["Chicago Headache Center and Research Institute","Torphy, Bradley","美国","ILLINOIS","Chicago"],["Centrum Medyczne Linden","Krawczyk, Malgorzata","波兰","(空)","Krakow"],["Medipoint Hospitals Pvt. Ltd.","Jog, Pramod","印度","(空)","Maharashtra"],["Headlands Research-El Paso","Casey, Ryan Patrick","美国","TEXAS","El Paso"],["AMR Baber Research Incorporated","Baber, Riaz Ahmad","美国","N/A","Naperville"],["Xenoscience","Flitman, Stephen","美国","ARIZONA","Phoenix"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["北京大学人民医院伦理审查委员会","同意","2025-01-27"]]

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: 15 ； 国际: 200 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 8 ；
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：2024-11-15；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2024-12-14；
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；