A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
2026년 8월 26일 업데이트: Kallyope Inc.
This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.
연구 개요
연구 유형
중재적
등록 (추정된)
1000
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Annemarie Vance
- 전화번호: 917-336-3654
- 이메일: annemarie@kallyope.com
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35205
- 모병
- Central Research Associates, LLC (CRA) dba Flourish Research
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Mobile, Alabama, 미국, 36608
- 모병
- AMR Mobile
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Arizona
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Chandler, Arizona, 미국, 85286
- 모병
- TrialSphere
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- 모병
- Arkansas Clinical Research
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California
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Colton, California, 미국, 92324
- 모병
- Axiom Research, LLC
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Culver City, California, 미국, 90230
- 모병
- Proscience Research Group
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Encino, California, 미국, 91316
- 모병
- Leading Edge Research LA, LLC
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Irvine, California, 미국, 92604
- 모병
- Axiom Research, Orange County
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Los Angeles, California, 미국, 90048
- 모병
- Clinical Research Institute
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Los Angeles, California, 미국, 90017
- 모병
- Downtown L.A. Research Center, Inc.
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Mission Viejo, California, 미국, 92691
- 모병
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Oceanside, California, 미국, 92056
- 모병
- Excell Research
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Pomona, California, 미국, 91767
- 모병
- The Neurology Group
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Pomona, California, 미국, 91767
- 모병
- Empire Clinical Research
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Riverside, California, 미국, 92503
- 모병
- Artemis Institute for Clinical Research
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San Diego, California, 미국, 92120
- 모병
- Acclaim Clinical Research
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Sherman Oaks, California, 미국, 91403
- 모병
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Spring Valley, California, 미국, 91978
- 모병
- Encompass Clinical Research
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Walnut Creek, California, 미국, 94598
- 모병
- Diablo Clinical Research
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Walnut Creek, California, 미국, 94596
- 모병
- Sunwise Clinical Research
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West Covina, California, 미국, 91790
- 모병
- Kinetic Clinical Research
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West Hills, California, 미국, 91307
- 모병
- Focus Clinical Research
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Colorado
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Centennial, Colorado, 미국, 80112
- 모병
- IMMUNOe Research Centers
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Colorado Springs, Colorado, 미국, 80910
- 모병
- MCB Clinical Research Centers
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Fort Collins, Colorado, 미국, 80528
- 모병
- Advanced Neurosciences Research
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Connecticut
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Waterbury, Connecticut, 미국, 06708
- 모병
- Chase Medical Research, LLC
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Georgia
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Atlanta, Georgia, 미국, 30329
- 모병
- DelRicht Research
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Marietta, Georgia, 미국, 30060
- 모병
- Drug Studies America
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Stockbridge, Georgia, 미국, 30281
- 모병
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Illinois
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Chicago, Illinois, 미국, 60607
- 모병
- Cedar Crosse Research Center
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Chicago, Illinois, 미국, 60657
- 모병
- Chicago Headache Center & Research Institute
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Flossmoor, Illinois, 미국, 60447
- 모병
- Healthcare Research Network II, LLC
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Naperville, Illinois, 미국, 60563
- 모병
- Chicago Headache Center & Research Institute
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Iowa
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West Des Moines, Iowa, 미국, 50265
- 모병
- Integrated Clinical Trials Solution
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Kansas
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Overland Park, Kansas, 미국, 66214
- 모병
- Clinical Associates Midwest, LLC
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Overland Park, Kansas, 미국, 66212
- 모병
- Collective Medical Research
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Wichita, Kansas, 미국, 67207
- 모병
- Heartland Research Associates, LLC - An AMR Company
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Kentucky
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Bardstown, Kentucky, 미국, 40004
- 모병
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Lexington, Kentucky, 미국, 40509
- 모병
- AMR Clinical - Lexington
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Lexington, Kentucky, 미국, 45212
- 모병
- CTI Clinical Research Center
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Louisiana
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Chalmette, Louisiana, 미국, 70043
- 모병
- Crescent City Headache & Neurology Center
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New Orleans, Louisiana, 미국, 70115
- 모병
- DelRicht Research
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Maryland
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Pikesville, Maryland, 미국, 21208
- 모병
- Headlands Research - Pharmasite
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Massachusetts
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Boston, Massachusetts, 미국, 02131
- 모병
- Boston Clinical Trials - Alcanza
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Waltham, Massachusetts, 미국, 02451
- 모병
- MedVadis Research Corporation, LLC
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Michigan
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Ann Arbor, Michigan, 미국, 48104
- 모병
- Michigan Headache Pain & Neurological Institute
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Minnesota
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Minneapolis, Minnesota, 미국, 55402
- 모병
- Clinical Research Institute
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Mississippi
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Gulfport, Mississippi, 미국, 39503
- 모병
- DelRicht Research
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Ridgeland, Mississippi, 미국, 39157
- 모병
- Proven Endpoints
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Missouri
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City of Saint Peters, Missouri, 미국, 63303
- 모병
- StudyMetrix Research
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Hazelwood, Missouri, 미국, 63042
- 모병
- Healthcare Research Network
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Kansas City, Missouri, 미국, 64114
- 모병
- AMR Clinical - Kansas City
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Springfield, Missouri, 미국, 65807
- 모병
- Clinvest Headlands Llc
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St Louis, Missouri, 미국, 63141
- 모병
- Sundance Clinical Research
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Nevada
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Las Vegas, Nevada, 미국, 89109
- 모병
- Excel Clinical Research
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Las Vegas, Nevada, 미국, 89119
- 모병
- Redbird Research
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Las Vegas, Nevada, 미국, 89102
- 모병
- Ima Clinical Research - Las Vegas
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Las Vegas, Nevada, 미국, 89118
- 모병
- Wake Research Las Vegas Rainbow
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Las Vegas, Nevada, 미국, 89119
- 모병
- AMR Clinical - Las Vegas
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North Las Vegas, Nevada, 미국, 89030
- 모병
- Las Vegas Clinical Trials
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Reno, Nevada, 미국, 89511
- 모병
- Advanced Research Institute-Reno
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New Mexico
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Albuquerque, New Mexico, 미국, 87102
- 모병
- Albuquerque Clinical Trials
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New York
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Amherst, New York, 미국, 14226
- 모병
- Dent Neuro Institute, Buffalo
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Brooklyn, New York, 미국, 11235
- 모병
- SPRI Clinical Trials, LLC
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Commack, New York, 미국, 11725
- 모병
- True North Neurology
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Manlius, New York, 미국, 13104
- 모병
- Central New York Clinical Research
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New York, New York, 미국, 10017
- 모병
- Fieve Clinical Research, Inc
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Rochester, New York, 미국, 14609
- 모병
- Rochester Clinical Research
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Williamsville, New York, 미국, 14221
- 모병
- Upstate Clinical Research Associates
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North Carolina
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Charlotte, North Carolina, 미국, 28277
- 모병
- Onsite Clinical Solutions
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Greensboro, North Carolina, 미국, 27405
- 모병
- Headache Wellness Center
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Greensboro, North Carolina, 미국, 27405
- 모병
- Guilford Neurologic Research Partners, LLC
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Raleigh, North Carolina, 미국, 27607
- 모병
- Eximia Research - NC, LLC
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Shelby, North Carolina, 미국, 28150
- 모병
- Carolina Research Center, Inc
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Ohio
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Columbus, Ohio, 미국, 43228
- 모병
- Hometown Research
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Milford, Ohio, 미국, 45150
- 모병
- Hometown Research
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West Chester, Ohio, 미국, 45069
- 모병
- CincyScience
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Oklahoma
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Edmond, Oklahoma, 미국, 73034
- 모병
- OK Clinical Research, LLC
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Oklahoma City, Oklahoma, 미국, 73102
- 모병
- Hightower Clinical
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Tulsa, Oklahoma, 미국, 74133
- 모병
- DelRicht Research
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Yukon, Oklahoma, 미국, 73099
- 모병
- Tekton Research, Inc.
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Oregon
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Portland, Oregon, 미국, 97210
- 모병
- Summit Research Network
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Portland, Oregon, 미국, 97223
- 모병
- Advanced Research Institute-Portland
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Pennsylvania
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Allentown, Pennsylvania, 미국, 18103
- 모병
- Lehigh Center For Clinical Research
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Philadelphia, Pennsylvania, 미국, 19114
- 모병
- Clinical Research Philadelphia
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Pittsburgh, Pennsylvania, 미국, 15236
- 모병
- Preferred Primary Care Physicians, Inc.
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Scottdale, Pennsylvania, 미국, 15683
- 모병
- Frontier Clinical Research, LLC
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Smithfield, Pennsylvania, 미국, 15478
- 모병
- Frontier Clinical Research, LLC
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South Carolina
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North Charleston, South Carolina, 미국, 29405
- 모병
- Coastal Carolina Research Center
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Tennessee
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Chattanooga, Tennessee, 미국, 37421
- 모병
- WR-ClinSearch, LLC
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Nashville, Tennessee, 미국, 37203
- 모병
- Clinical Research Associates, Inc.
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Nashville, Tennessee, 미국, 37203
- 모병
- Access Clinical Trials Inc
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Texas
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Austin, Texas, 미국, 78731
- 모병
- FutureSearch Trials of Neurology
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Austin, Texas, 미국, 78745
- 모병
- Tekton Research
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Cypress, Texas, 미국, 77372
- 모병
- APD Clinical Research
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Cypress, Texas, 미국, 77429
- 모병
- Horizon Clinical Research and Gill Neuroscience
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Dallas, Texas, 미국, 75251
- 모병
- FutureSearch Trials of Dallas, LP
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Houston, Texas, 미국, 77081
- 모병
- DM Clinical Research
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Houston, Texas, 미국, 77024
- 모병
- Victorium Clinical Research
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Lampasas, Texas, 미국, 76550
- 모병
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Plano, Texas, 미국, 75093
- 모병
- AIM Trials, LLC
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Waxahachie, Texas, 미국, 75165
- 모병
- ClinPoint Trials
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Utah
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Bountiful, Utah, 미국, 84010
- 모병
- Pantheon Clinical Research
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Draper, Utah, 미국, 84020
- 모병
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Ogden, Utah, 미국, 84405
- 모병
- Advanced Research Institute
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Riverton, Utah, 미국, 84096
- 모병
- Granger Medical Clinic
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Salt Lake City, Utah, 미국, 84109
- 모병
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, 미국, 84121
- 모병
- J. Lewis Research, Inc. / Foothill Family Clinic
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Virginia
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Newport News, Virginia, 미국, 23606
- 모병
- Health Research of Hampton Roads, Inc. (HRHR)
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Norfolk, Virginia, 미국, 23502
- 모병
- AMR Clinical - Norfolk
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Washington
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Seattle, Washington, 미국, 98104
- 모병
- Seattle Clinical Research Center
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West Virginia
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Morgantown, West Virginia, 미국, 26505
- 모병
- Frontier Clinical Research
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Wisconsin
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Kenosha, Wisconsin, 미국, 53144
- 모병
- Clinical Investigation Specialists, Inc.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins' in the base study and completed the 2-hour and 4-hour post-dose assessments in the eDiary.
Note: If a subject treats their qualifying migraine in the base study within 5 days of randomization (i.e. ≤ 4 daily check-ins should have been completed in the eDiary), they are eligible for this study if they missed 1 daily check-in, even though compliance was <80%;
- Participant voluntarily agrees to participate in the study by giving written informed consent;
- Participant is able to read, understand, and complete the study questionnaires and diary;
- Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;
- Participant is willing to use his/her own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration of the study;
- For females of reproductive potential (as determined in the base study), continues to agree to remain abstinent from heterosexual activity or a. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the EoS visit.
Acceptable methods of birth control are:
i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral; injectable; implantable; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence*; progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).
- Abstinence can be used as the sole method of contraception if it is in line with the participant's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.
Exclusion Criteria:
- Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study);
- Has, at the time of the base study EoS/Visit 3, had any change in medical history or a laboratory finding since screening in the acute treatment study that in the opinion of the investigator renders the participant unsuitable for this study (e.g., development of a finding that would have precluded participation in the base acute treatment study);
- Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS) taken during the base study E0S/Visit 3, or of harm to others in the opinion of the investigator. Participants must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in 'since last version' version of the C-SSRS;
- Participant is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during trial participation) as assessed for the base study E0S/Visit 3;
- Has any major surgery scheduled for the duration of the trial;
- Has any other unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with the interpretation of efficacy and/or safety results;
- At Visit 1, has an open/ongoing adverse event from the base study EoS visit;
- Experienced a serious adverse event in the base study;
- Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Elismetrep 10 mg
|
구두로 관리
Administered orally
다른 이름들:
|
|
실험적: Elismetrep 20 mg
|
Administered orally
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Proportion of participants with at least one treatment-emergent adverse event (TEAE)
기간: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
|
Proportion of participants with at least one treatment-emergent serious adverse event (SAE)
기간: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
|
Proportion of participants with TEAEs leading to study drug discontinuation
기간: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
|
Proportion of participants with TEAEs that occur in at least 5% of treated participants in either treatment arm
기간: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 8월 3일
기본 완료 (추정된)
2028년 6월 1일
연구 완료 (추정된)
2028년 6월 1일
연구 등록 날짜
최초 제출
2026년 6월 15일
QC 기준을 충족하는 최초 제출
2026년 6월 23일
처음 게시됨 (실제)
2026년 6월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 26일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- K-304 P005
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .