Galcanezumab 预防发作性偏头痛的疗效和安全性评估 - EVOLVE-2 研究 (EVOLVE-2)
2020年6月10日 更新者：Eli Lilly and Company
LY2951742 在发作性偏头痛患者中的 3 期、随机、双盲、安慰剂对照研究 - EVOLVE-2 研究
本研究的主要目的是评估称为 galcanezumab 的研究药物在发作性偏头痛参与者中的疗效和安全性。
研究概览
研究类型
介入性
注册 (实际的)
986
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
- Hillel Yaffe
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Haifa、以色列、3525408
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Kfar Saba、以色列、4420122
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Ramat Gan、以色列、5266202
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Kaohsiung、台湾、80756
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Taichung、台湾、43761
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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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Merida、墨西哥、97070
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Mexico City、墨西哥、03740
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México City、墨西哥、03310
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Hwaseong-si、大韩民国、18450
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Seoul、大韩民国、03080
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Seoul、大韩民国、01830
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Seoul、大韩民国、03181
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Seoul、大韩民国、06351
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Seoul、大韩民国、07441
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Seoul、大韩民国、08308
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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
- 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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Bochum、德国、44797
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Essen、德国、45147
- 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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Halle、德国、06120
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Hamburg、德国、20246
- 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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Jena、德国、07747
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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
- 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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Prien、德国、83209
- 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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Tübingen、德国、72076
- 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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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、182 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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Las Piedras、波多黎各、00771
- Cortex, PSC
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San Juan、波多黎各、00918
- SomniCare Sleep Institute
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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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Apple Valley、California、美国、92307
- Axiom Research
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Los Angeles、California、美国、90048
- Cedars Sinai Medical Center
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Montclair、California、美国、91763
- Catalina Research Institute, LLC
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Oakland、California、美国、94607
- Pacific Research Partners, LLC
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San Diego、California、美国、92108
- Medical Center for Clinical Research
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San Francisco、California、美国、94102
- Optimus Medical Group
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Sherman Oaks、California、美国、91403
- Schuster Medical Research Institute
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Colorado
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Centennial、Colorado、美国、80112
- IMMUNOe International Research Centers
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Florida
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Coral Gables、Florida、美国、33134
- Clinical Research of South Florida
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Hollywood、Florida、美国、33021
- Sunrise Clinical Research
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Jacksonville、Florida、美国、32205
- Westside Center for Clinical Research
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Jacksonville、Florida、美国、32256
- Clinical NeuroScience Solutions Inc
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Ocoee、Florida、美国、34761
- Sensible Healthcare
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Tampa、Florida、美国、33634
- Meridien Research
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Georgia
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Atlanta、Georgia、美国、30331
- Atlanta Center of Medical Research
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Illinois
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Champaign、Illinois、美国、61820
- Christie Clinic, LLC
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Chicago、Illinois、美国、60642
- Diamond Headache Clinic
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Indiana
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Indianapolis、Indiana、美国、46256
- Josephson Wallack Munshower Neurology
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Kansas
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Wichita、Kansas、美国、67205
- Heartland Research Associates
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Massachusetts
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New Bedford、Massachusetts、美国、02740
- Novex Clinical Research
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Michigan
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Farmington Hills、Michigan、美国、48334
- Quest Research Institute
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Missouri
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Hazelwood、Missouri、美国、63042
- Healthcare Research Network - Hazelwood
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Nevada
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Las Vegas、Nevada、美国、89113
- Nevada Headache Institute
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New Jersey
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Toms River、New Jersey、美国、08755
- Bio Behavioral Health
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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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Binghamton、New York、美国、13760
- Regional Clinical Research
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Brooklyn、New York、美国、11235
- SPRI Clinical Trials, LLC.
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North Carolina
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High Point、North Carolina、美国、27265
- High Point Clinical Trials Center
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Ohio
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Akron、Ohio、美国、44320
- Neurology & Neuroscience Associates, Inc.
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Cincinnati、Ohio、美国、45219
- Univ of Cincinnati College of Medicine
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Columbus、Ohio、美国、43214
- Urgent Care Specialists, LLC
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Dayton、Ohio、美国、45424
- Urgent Care Specialists, LLC
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Oklahoma
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Oklahoma City、Oklahoma、美国、73103
- IPS Research Company
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Oregon
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Springfield、Oregon、美国、97477
- Oregon Neurology Associates
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19114
- Clinical Research of Philadelphia
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South Carolina
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Greer、South Carolina、美国、29651
- Mountain View Clinical Research, Inc
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Mount Pleasant、South Carolina、美国、29464
- Coastal Carolina Research Center, Inc.
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Texas
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Dallas、Texas、美国、75231
- FutureSearch Trials
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Houston、Texas、美国、77074
- Clinical Trial Network
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Waxahachie、Texas、美国、75165
- Clinpoint Trial, LLC
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Utah
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Salt Lake City、Utah、美国、84109
- Foothill Family Clinic
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South Jordan、Utah、美国、84095
- Jordan River Family Medicine
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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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Seattle、Washington、美国、98104
- Polyclinic
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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
- 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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Liverpool、英国、L9 7LJ
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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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Geleen、荷兰、6162 BG
- 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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Tilburg、荷兰、5042 AD
- 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、08907
- 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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Elda、西班牙、03600
- 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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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 Aires、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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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
16年 至 63年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 诊断为国际头痛协会 (IHS) 国际头痛疾病分类 (ICHD)-3 测试版（1.1 或 1.2）（ICHD-3 2013）所定义的偏头痛，并且至少有 1 年的偏头痛病史筛选、50 岁前偏头痛发作和 4-14 MHD 的每月频率。
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Galcanezumab 120 毫克
Galcanezumab 240mg 作为负荷剂量在首次给药就诊时给予，随后通过皮下 (SC) 注射每月一次给予 Galcanezumab 120mg，持续 5 个月。
|
施行SC
其他名称：
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实验性的：Galcanezumab 240 毫克
Galcanezumab 240mg 皮下注射，每月一次，持续 6 个月。
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施行SC
其他名称：
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安慰剂比较：安慰剂
每月一次 SC 注射安慰剂，持续 6 个月。
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施行SC
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实验性的：Galcanezumab 120mg 最大扩展登记队列
Galcanezumab 240mg 作为负荷剂量在首次给药就诊时给予，随后通过皮下 (SC) 注射每月一次给予 Galcanezumab 120mg，持续 5 个月。
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施行SC
其他名称：
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实验性的：Galcanezumab 240mg 最大扩展登记队列
Galcanezumab 240mg 皮下注射，每月一次，持续 6 个月。
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施行SC
其他名称：
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安慰剂比较：安慰剂最大扩展登记队列
每月一次 SC 注射安慰剂，持续 6 个月。
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施行SC
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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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每月偏头痛天数相对于基线的总体平均变化
大体时间：基线，第 1 个月到第 6 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。 偏头痛：头痛，有或没有先兆，持续时间≥30 分钟，同时具有以下两个要求的特征（A 和 B）： A) 至少具有以下头痛特征中的 2 项： 单侧定位；脉动质量；中度或重度疼痛强度；因日常体力活动加重或导致避免日常体力活动；和 B) 在头痛期间至少出现以下情况之一： 恶心和/或呕吐；畏光和声音恐惧症； 总体平均值来自混合模型重复测量 (MMRM) 模型的第 1 至 6 个月的平均值。 使用混合模型重复测量 (MMRM) 模型计算最小二乘 (LS) 平均值，其中治疗、合并国家/地区、月份和按月治疗、基线和按月基线作为固定效应。 |
基线，第 1 个月到第 6 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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每月偏头痛天数从基线减少 ≥ 50%、≥ 75% 和 100% 的参与者的平均百分比
大体时间：基线，第 1 个月到第 6 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。 平均值来自广义线性混合模型重复测量的第 1 至 6 个月的平均值。 使用广义线性混合模型重复测量方法计算参与者的平均百分比，包括治疗、月份和按月治疗、基线。 |
基线，第 1 个月到第 6 个月
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偏头痛特定生活质量问卷 (MSQ) 2.1 版角色功能限制域相对于基线的平均变化
大体时间：基线，第 4 个月至第 6 个月
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开发 MSQ v2.1 是为了解决偏头痛患者特别关注的身体和情绪限制。 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. 总原始分数为每个domain 是该域中所有项目的最终项目值的总和。在为每个域计算总原始分数后，它们将转换为 0-100 等级，分数越高表示健康状况越好&积极变化在反映功能改善的分数中。 平均值来自 MMRM 模型第 4 至 6 个月的平均值。 LSMean 是使用 MMRM 模型计算的，其中治疗、合并国家、月份、按月治疗、按月基线和基线 MHD 类别作为固定因素。 |
基线，第 4 个月至第 6 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 6 个月
|
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 6 个月的平均值。LSMean 是使用 MMRM 模型计算的，其中治疗、合并国家、月份、按月治疗、基线、按月基线和基线 MHD 类别作为固定效应。 |
基线，第 1 个月到第 6 个月
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患者总体严重性印象 (PGI-S) 评级相对于基线的平均变化
大体时间：基线，第 4 个月至第 6 个月
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PGI-S 量表是一种参与者评定的工具，用于衡量患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”）。
平均值来自 MMRM 模型第 4 至 6 个月的平均值。
LSMean 是使用 MMRM 模型计算的，其中治疗、合并国家、月份、按月治疗、基线、按月基线和基线 MHD 类别作为固定因素。
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基线，第 4 个月至第 6 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 6 个月
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头痛小时数计算为发生头痛的头痛小时总数。
总体平均值来自 MMRM 模型第 1 至 6 个月的平均值。
LSMean 是使用 MMRM 模型计算的，包括治疗、合并国家、月份、按月治疗、基线、按月基线和基线 MHD 类别。
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基线，第 1 个月到第 6 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 6 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 MMRM 模型计算的，其中治疗、合并国家、月份、按月治疗、基线、按月基线和基线 MHD 类别作为固定因素。 |
基线，第 6 个月
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对 Galcanezumab 产生抗药抗体 (ADA) 的参与者百分比
大体时间：第 1 个月到第 6 个月
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如果受试者的基线后滴度至少比基线测量增加 4 倍或更多，则治疗紧急 (TE) ADA 可评估参与者被认为是 TE ADA+。
如果基线结果为 ADA 不存在，则如果存在至少一个 ADA 基线后结果且效价 >= 1: 20，则参与者为 TE ADA+。
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第 1 个月到第 6 个月
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药代动力学 (PK)：Galcanezumab 的血清浓度
大体时间：第 6 个月
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药代动力学 (PK)：Galcanezumab 的血清浓度。
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第 6 个月
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降钙素基因相关肽 (CGRP) 的血浆浓度
大体时间：第 6 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 6 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
- 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.
- 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.
- 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.
- Jedynak J, Eross E, Gendolla A, Rettiganti M, Stauffer VL. Shift from high-frequency to low-frequency episodic migraine in patients treated with Galcanezumab: results from two global randomized clinical trials. J Headache Pain. 2021 May 28;22(1):48. doi: 10.1186/s10194-021-01222-w.
- 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. Review.
- 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.
- Silberstein SD, Stauffer VL, Day KA, Lipsius S, Wilson MC. Galcanezumab in episodic migraine: subgroup analyses of efficacy by high versus low frequency of migraine headaches in phase 3 studies (EVOLVE-1 & EVOLVE-2). J Headache Pain. 2019 Jun 28;20(1):75. doi: 10.1186/s10194-019-1024-x. Erratum In: J Headache Pain. 2019 Dec 27;20(1):118.
- Stauffer VL, Wang S, Voulgaropoulos M, Skljarevski V, Kovacik A, Aurora SK. Effect of Galcanezumab Following Treatment Cessation in Patients With Migraine: Results From 2 Randomized Phase 3 Trials. Headache. 2019 Jun;59(6):834-847. doi: 10.1111/head.13508. Epub 2019 Apr 3.
- 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.
- Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018 Jul;38(8):1442-1454. doi: 10.1177/0333102418779543. Epub 2018 May 31.
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12月4日
初级完成 (实际的)
2017年3月29日
研究完成 (实际的)
2018年10月5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)
2020年6月17日
上次提交的符合 QC 标准的更新
2020年6月10日
最后验证
2020年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 15768
- I5Q-MC-CGAH (其他标识符：Eli Lilly and Company)
- 2015-001882-17 (EudraCT编号)
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
- 研究协议
- 统计分析计划 (SAP)
- 临床研究报告（CSR）
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
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.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的