Galcanezumab 预防慢性偏头痛的评价 (REGAIN)
2022年4月25日 更新者：Eli Lilly and Company
LY2951742 在慢性偏头痛患者中的 3 期随机、双盲、安慰剂对照研究 - REGAIN 研究
本研究的主要目的是评估称为 galcanezumab 的研究药物对慢性偏头痛参与者的疗效。
研究概览
研究类型
介入性
注册 (实际的)
1117
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Hadera、以色列、38100
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Kfar Saba、以色列、4420122
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Ramat Gan、以色列、5266202
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Tel Aviv、以色列、6423906
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Brampton、加拿大、L6T 0G1
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Kelowna、加拿大、V1Y 1Z9
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Montreal、加拿大、H3A 2B4
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Ottawa、加拿大、K2G 6E2
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Kaohsiung、台湾、80756
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Tainan、台湾、70142
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Tainan、台湾、71004
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Taipei、台湾、11217
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Taipei、台湾、220
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Aguascalientes、墨西哥、20217
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Culiacan、墨西哥、80020
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México City、墨西哥、03310
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Berlin、德国、10117
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bielefeld、德国、33647
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Bochum、德国、44787
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Essen、德国、45147
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Hamburg、德国、20246
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Kassel、德国、34121
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Königstein、德国、61462
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Prien、德国、83209
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Tübingen、德国、72076
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Bologna、意大利、40139
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Firenze、意大利、50134
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Modena、意大利、40124
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pavia、意大利、27100
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Roma、意大利、00163
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Brno、捷克语、656 91
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kladno、捷克语、27201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Praha 10、捷克语、100 00
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Praha 2、捷克语、120 00
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Praha 6、捷克语、160 00
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Praha 8、捷克语、1790 12
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manati、波多黎各、00674
- Office of Dr. Ruddy Guerra
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San Juan、波多黎各、00909
- GCM Medical Group PSC
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San Juan、波多黎各、00918
- Instituto De Neurologia Dra. Ivonne Fraga
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San Juan、波多黎各、00926
- Neuro GI Wellness Center
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Arizona
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Phoenix、Arizona、美国、85023
- Arizona Research Center
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Phoenix、Arizona、美国、85004
- 21st Century Neurology
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California
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Encino、California、美国、91316
- Pharmacology Research Institute, Encino
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Fullerton、California、美国、92835
- Fullerton Neurology and Headache Center
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Los Alamitos、California、美国、90720
- Pharmacology Research Institute, Los Alamitos
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Newport Beach、California、美国、92660
- Pharmacology Research Institute, Newport Beach
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Rancho Mirage、California、美国、92270
- Desert Valley Research
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Redlands、California、美国、92374
- Anderson Clinical Research
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San Diego、California、美国、92108
- Medical Center for Clinical Research
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San Diego、California、美国、92103
- Artemis Institute for Clinical Research
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San Francisco、California、美国、94102
- Optimus Medical Group
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Colorado
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Englewood、Colorado、美国、80113
- Colorado Neurological Institute
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Fort Collins、Colorado、美国、80528
- Advanced Neurosciences Research, LLC
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Connecticut
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Fairfield、Connecticut、美国、06824
- Associated Neurologists of Southern Connecticut
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Florida
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DeLand、Florida、美国、32720
- Avail Clinical Research LLC
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Jacksonville、Florida、美国、32256
- Clinical Neuroscience Solutions Inc
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Ocala、Florida、美国、34471
- |Renstar Medical Research
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Orlando、Florida、美国、32801
- Psychiatric Inst of Florida-Clinical Neuroscience Solutions
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Oviedo、Florida、美国、32765
- Compass Research
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West Palm Beach、Florida、美国、33407
- Premiere Research Institute at Palm Beach Neurology
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Idaho
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Boise、Idaho、美国、83704
- Northwest Clinical Trials
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Illinois
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Champaign、Illinois、美国、61820
- Christie Clinic, LLC
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Riverwoods、Illinois、美国、60015
- Robbins Headache Clinic
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Indiana
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Indianapolis、Indiana、美国、46260
- Midwest Institute for Clinical Research
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Kansas
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Prairie Village、Kansas、美国、66208
- Phoenix Medical Research, Inc
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Wichita、Kansas、美国、67205
- Heartland Research Associates
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Maryland
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Baltimore、Maryland、美国、21208
- Pharmasite Research Inc
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Massachusetts
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Boston、Massachusetts、美国、02131
- Boston Clinical Trials Inc
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Michigan
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Ann Arbor、Michigan、美国、48104
- Michigan Head, Pain and Neurological Institute
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Minnesota
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Minneapolis、Minnesota、美国、55402
- Clinical Research Institute
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Missouri
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Hazelwood、Missouri、美国、63042
- Healthcare Research Network - Hazelwood
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Springfield、Missouri、美国、65807
- Clinvest
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New Mexico
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Albuquerque、New Mexico、美国、87102
- Albuquerque Clinical Trials
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New York
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Amherst、New York、美国、14226
- Dent Neurological Institute
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Plainview、New York、美国、11803
- Island Neuro Associates,PC
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Ohio
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Cincinnati、Ohio、美国、45219
- Univ of Cincinnati College of Medicine
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Oklahoma
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Tulsa、Oklahoma、美国、74135
- Healthcare Research Consultant
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Pennsylvania
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Pleasant Hills、Pennsylvania、美国、15236
- Preferred Primary Care Physicians
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Willow Grove、Pennsylvania、美国、19090
- Abington Neurological Associates
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South Carolina
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Charleston、South Carolina、美国、29406
- Clinical Trials of South Carolina
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Columbia、South Carolina、美国、29203
- University of South Carolina
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Mount Pleasant、South Carolina、美国、29464
- Coastal Carolina Research Center, Inc.
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Spartanburg、South Carolina、美国、29307
- BG Neurology
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Tennessee
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Chattanooga、Tennessee、美国、37421
- ClinSearch
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Texas
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Austin、Texas、美国、78731
- FutureSearch Trials of Neurology and Sleep Lab
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Dallas、Texas、美国、75231
- Headache Medicine Specialist of North Texas
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Utah
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Salt Lake City、Utah、美国、84109
- Foothill Family Clinic
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Virginia
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Newport News、Virginia、美国、23606
- Health Research of Hampton Roads Inc
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Virginia Beach、Virginia、美国、23456
- Sentara Neurology Specialists
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Washington
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Bellevue、Washington、美国、98007-4209
- Northwest Clinical Research Center
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Spokane、Washington、美国、99202
- Premier Clinical Research
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Wisconsin
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Middleton、Wisconsin、美国、53562
- Dean Foundation for Health Research and Education
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Glasgow、英国、G51 4TF
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hull、英国、HU3 2JZ
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London、英国、SE5 9RS
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Stoke-on-Trent、英国、ST4 6QG
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Amsterdam、荷兰、1078 VV
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Leiden、荷兰、2333 ZA
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nijmegen、荷兰、6532 SZ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zwolle、荷兰、8025 AB
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona、西班牙、08035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona、西班牙、08028
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pamplona、西班牙、31008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Santander、西班牙、39008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valencia、西班牙、46010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valencia、西班牙、46026
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valladolid、西班牙、47005
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Buenos Aires、阿根廷、C1056ABJ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ciudad Autonoma de Buenos Aire、阿根廷、C1012AAR
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ciudad Autonoma de Buenos Aire、阿根廷、C1013AAB
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ciudad Autonoma de Buenos Aire、阿根廷、C1128AAF
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ciudad Autonoma de Buenos Aire、阿根廷、C1046AAQ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ciudad Autonoma de Buenos Aire、阿根廷、C1204AAD
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ciudad Autonoma de Buenos Aire、阿根廷、C1428AQK
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ciudad Autonoma de Buenos Aire、阿根廷、C1430EGF
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cordoba、阿根廷、X5000EDC
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cordoba、阿根廷、X5021FPQ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、OLDER_ADULT)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
主要研究：
- 诊断为国际头痛协会 (IHS) 国际头痛疾病分类 (ICHD)-3 beta 指南 (1.3) (ICHD-3 2013) 所定义的慢性偏头痛，且至少有 1 年的偏头痛病史筛选和偏头痛发作在 50 岁之前。
以色列附录：
- 参与者必须完成主要研究的所有阶段，包括 4 个月的治疗后随访阶段，在此期间不使用研究产品。
- 研究者还必须认为参与者已从 galcanezumab 治疗中获益，并且必须已经用尽了预防偏头痛的替代疗法。
排除标准：
- 目前正在参加或在过去 30 天内或 5 个半衰期（以较长者为准）参与涉及研究产品的临床试验。
- 当前使用或之前接触过 galcanezumab 或其他降钙素基因相关肽 (CGRP) 抗体。
- 已知对多种药物、单克隆抗体或其他治疗性蛋白质或 galcanezumab 过敏。
- 持续性每日头痛、丛集性头痛或偏头痛亚型的病史，包括偏瘫性（散发性或家族性）偏头痛、眼肌麻痹性偏头痛和 IHS ICHD-3 beta 定义的脑干先兆偏头痛（基底型偏头痛）。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：平行线
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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PLACEBO_COMPARATOR：安慰剂
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施行SC
施行SC
其他名称：
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实验性的：Galcanezumab 120 毫克
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施行SC
其他名称：
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实验性的：Galcanezumab 240 毫克
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施行SC
其他名称：
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实验性的：以色列附录
来自主要研究的合格参与者被纳入以色列附录。
参与者每月一次接受 120 毫克或 240 毫克的 galcanezumab SC，由研究者自行决定，持续长达 3 年或直到不再满足以色列卫生部的持续使用条件，以先发生者为准。
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施行SC
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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每月偏头痛天数 (MHD) 相对于基线的总体平均变化
大体时间：基线，第 1 个月到第 3 个月
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MHD：发生偏头痛或疑似偏头痛的日历日。 总体平均值来自混合模型重复测量 (MMRM) 模型的第 1 至 3 个月的平均值。 使用 MMRM 模型计算最小二乘 (LS) 平均值，其中治疗、合并国家、基线药物过度使用、同时预防使用、月、按月治疗、基线和按月基线作为固定效应。 |
基线，第 1 个月到第 3 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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每月偏头痛天数较基线减少 ≥50%、≥75% 和 100% 的参与者人数
大体时间：基线，第 1 个月到第 3 个月
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MHD：发生偏头痛或疑似偏头痛的日历日。
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基线，第 1 个月到第 3 个月
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偏头痛特定生活质量问卷 (MSQ) 角色功能限制域相对于基线的平均变化
大体时间：基线，第 3 个月
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MSQ v2.1 是一种健康状况工具，具有 4 周的回顾期，旨在解决偏头痛患者特别关注的身体和情绪限制。
解决偏头痛对工作或日常活动、与家人和朋友的关系、休闲时间、生产力、注意力、精力、疲劳和感觉的影响。
它由涉及 3 个领域的 14 个项目组成：(1) 角色功能 - 限制性（项目 1-7）；（2）角色功能 - 预防（项目 8-11）；（3）情感功能（项目 12-14） .Response options range from "none of the time" (value 1) to "all the time" (value 6),& are reverse-recoded (value 6 to 1) before the domain scores are calculated.
每个域的总原始分数是该域中所有项目的最终项目值的总和。
在为每个领域计算总的原始分数后，将它们转换为 0-100 的等级，分数越高表示健康状况越好，分数的积极变化反映功能的改善。
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基线，第 3 个月
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需要药物治疗偏头痛或头痛的每月偏头痛天数相对于基线的总体平均变化
大体时间：基线，第 1 个月到第 3 个月
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偏头痛日 (MHD)：发生偏头痛或疑似偏头痛的日历日。 总体平均值来自 MMRM 模型第 1 至 3 个月的平均值。 LSMean 是使用 MMRM 模型计算的，其中治疗、合并国家、基线药物过度使用、同时预防使用、月、按月治疗、基线和按月基线作为固定效应。 |
基线，第 1 个月到第 3 个月
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患者总体严重性印象 (PGI-S) 评分相对于基线的平均变化
大体时间：基线，第 3 个月
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PGI-S 量表是一种参与者评定工具，用于衡量参与者对其疾病严重程度的总体印象。
参与者被指示如下：“考虑到偏头痛是一种慢性疾病，你如何评价你的疾病程度？”反应选项是从 1（“正常，一点也不生病”）到 7（“病得很重”）。
LSMean 是使用 MMRM 模型计算的，其中治疗、合并国家、基线药物过度使用、同时预防使用、月、按月治疗、基线和按月基线作为固定效应。
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基线，第 3 个月
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头痛时间相对于基线的总体平均变化
大体时间：基线，第 1 个月到第 3 个月
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总体平均值来自 MMRM 模型第 1 至 3 个月的平均值。
LSMean 是使用 MMRM 模型计算的，其中治疗、合并国家、基线药物过度使用、同时预防使用、月、按月治疗、基线和按月基线作为固定效应。
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基线，第 1 个月到第 3 个月
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偏头痛残疾评估测试 (MIDAS) 总分相对于基线的平均变化
大体时间：基线，第 3 个月
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MIDAS 是一种参与者评定量表，旨在量化 3 个月内与头痛相关的残疾。
该工具由五个项目组成，反映报告为失踪或工作或家庭生产力下降的天数，以及错过社交活动的天数。
每个项目都有一个从 0 到 90 天的数字响应范围，如果错过了上班或回家的日子，则这些日子不计为工作或家庭生产力下降的日子。
将数字响应相加以产生从 0 到 270 的总分，其中较高的值表示更多的残疾。
LSMean 是使用协方差分析 (ANCOVA) 模型计算的，最后一次观察结转 (LOCF) 包括治疗、合并国家、基线药物过度使用、同时预防使用和基线值作为固定效应。
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基线，第 3 个月
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开发针对 Galcanezumab 的治疗紧急抗药抗体 (ADA) 的参与者百分比
大体时间：第 1 个月到第 3 个月
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如果参与者至少有一个基线后滴度比基线测量值增加 4 倍或更多，则治疗紧急抗药抗体 (TE ADA) 可评估参与者被认为是 TE ADA+。
如果基线结果为 ADA Not Present，则如果至少有一个 ADA Present 基线后结果且效价 >= 20，则参与者为 TE ADA+。
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第 1 个月到第 3 个月
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药代动力学 (PK)：Galcanezumab 的浓度时间曲线下面积 (AUC)
大体时间：到第 3 个月的基线
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药代动力学 (PK)：Galcanezumab 的浓度时间曲线下面积 (AUC)。
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到第 3 个月的基线
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降钙素基因相关肽 (CGRP) 的血浆浓度
大体时间：第 3 个月
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降钙素基因相关肽 (CGRP) 的血浆浓度。
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第 3 个月
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Galcanezumab 的血清浓度
大体时间：第 3 个月
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Galcanezumab 的血清浓度
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第 3 个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.
- Pozo-Rosich P, Detke HC, Wang S, Dolezil D, Li LQ, Aurora SK, Reuter U. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 May;38(5):731-742. doi: 10.1080/03007995.2022.2059975. Epub 2022 Apr 15.
- Ailani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25.
- Citrome L, Sanchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15.
- Pozo-Rosich P, Samaan KH, Schwedt TJ, Nicholson RA, Rettiganti M, Pearlman EM. Galcanezumab Provides Consistent Efficacy Throughout the Dosing Interval Among Patients with Episodic and Chronic Migraine: A Post Hoc Analysis. Adv Ther. 2021 Jun;38(6):3154-3165. doi: 10.1007/s12325-021-01708-8. Epub 2021 May 5.
- Ament M, Day K, Stauffer VL, Skljarevski V, Rettiganti M, Pearlman E, Aurora SK. Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine. J Headache Pain. 2021 Feb 6;22(1):6. doi: 10.1186/s10194-021-01215-9. Erratum In: J Headache Pain. 2021 Aug 26;22(1):100.
- Kuruppu DK, North JM, Kovacik AJ, Dong Y, Pearlman EM, Hutchinson SL. Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials. Adv Ther. 2021 Mar;38(3):1614-1626. doi: 10.1007/s12325-021-01632-x. Epub 2021 Feb 5.
- Dodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J, Dong Y, Pearlman EM. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021 Mar;41(3):340-352. doi: 10.1177/0333102420966658. Epub 2020 Nov 3.
- Ailani J, Andrews JS, Rettiganti M, Nicholson RA. Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials). J Headache Pain. 2020 Oct 17;21(1):123. doi: 10.1186/s10194-020-01190-7.
- Ford J, Tassorelli C, Leroux E, Wang S, Ayer D, Nichols R, Detke H. Changes in patient functioning and disability: results from a phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating galcanezumab for chronic migraine prevention (REGAIN). Qual Life Res. 2021 Jan;30(1):105-115. doi: 10.1007/s11136-020-02623-1. Epub 2020 Sep 15.
- Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.
- Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7. Erratum In: BMC Neurol. 2020 Mar 13;20(1):90.
- Ruff DD, Ford JH, Tockhorn-Heidenreich A, Sexson M, Govindan S, Pearlman EM, Wang SJ, Khan A, Aurora SK. Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure. Cephalalgia. 2019 Jul;39(8):931-944. doi: 10.1177/0333102419847957. Epub 2019 May 19.
- Forderreuther S, Zhang Q, Stauffer VL, Aurora SK, Lainez MJA. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J Headache Pain. 2018 Dec 29;19(1):121. doi: 10.1186/s10194-018-0951-2.
- Nichols R, Doty E, Sacco S, Ruff D, Pearlman E, Aurora SK. Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies. Headache. 2019 Feb;59(2):192-204. doi: 10.1111/head.13443. Epub 2018 Nov 21.
- Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018 Dec 11;91(24):e2211-e2221. doi: 10.1212/WNL.0000000000006640. Epub 2018 Nov 16.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年11月30日
初级完成 (实际的)
2017年3月16日
研究完成 (实际的)
2021年7月14日
研究注册日期
首次提交
2015年11月23日
首先提交符合 QC 标准的
2015年11月23日
首次发布 (估计)
2015年11月25日
研究记录更新
最后更新发布 (实际的)
2022年5月18日
上次提交的符合 QC 标准的更新
2022年4月25日
最后验证
2022年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 15769
- I5Q-MC-CGAI (其他：Eli Lillly and Company)
- 2015-001883-21 (EUDRACT_NUMBER 个)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
在批准研究计划和签署数据共享协议后，将在安全访问环境中提供匿名的个人患者级别数据。
IPD 共享时间框架
在美国和欧盟研究的适应症首次公布和批准后 6 个月（以较晚者为准）可提供数据。
数据将无限期地可供请求。
IPD 共享访问标准
研究计划必须得到独立审查小组的批准，研究人员必须签署数据共享协议。
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.