A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
26 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
1000
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Annemarie Vance
- Numero di telefono: 917-336-3654
- Email: annemarie@kallyope.com
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35205
- Reclutamento
- Central Research Associates, LLC (CRA) dba Flourish Research
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Mobile, Alabama, Stati Uniti, 36608
- Reclutamento
- AMR Mobile
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Arizona
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Chandler, Arizona, Stati Uniti, 85286
- Reclutamento
- TrialSphere
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- Reclutamento
- Arkansas Clinical Research
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California
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Colton, California, Stati Uniti, 92324
- Reclutamento
- Axiom Research, LLC
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Culver City, California, Stati Uniti, 90230
- Reclutamento
- Proscience Research Group
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Encino, California, Stati Uniti, 91316
- Reclutamento
- Leading Edge Research LA, LLC
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Irvine, California, Stati Uniti, 92604
- Reclutamento
- Axiom Research, Orange County
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Los Angeles, California, Stati Uniti, 90048
- Reclutamento
- Clinical Research Institute
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Los Angeles, California, Stati Uniti, 90017
- Reclutamento
- Downtown L.A. Research Center, Inc.
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Mission Viejo, California, Stati Uniti, 92691
- Reclutamento
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Oceanside, California, Stati Uniti, 92056
- Reclutamento
- Excell Research
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Pomona, California, Stati Uniti, 91767
- Reclutamento
- The Neurology Group
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Pomona, California, Stati Uniti, 91767
- Reclutamento
- Empire Clinical Research
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Riverside, California, Stati Uniti, 92503
- Reclutamento
- Artemis Institute for Clinical Research
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San Diego, California, Stati Uniti, 92120
- Reclutamento
- Acclaim Clinical Research
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Sherman Oaks, California, Stati Uniti, 91403
- Reclutamento
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Spring Valley, California, Stati Uniti, 91978
- Reclutamento
- Encompass Clinical Research
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Walnut Creek, California, Stati Uniti, 94598
- Reclutamento
- Diablo Clinical Research
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Walnut Creek, California, Stati Uniti, 94596
- Reclutamento
- Sunwise Clinical Research
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West Covina, California, Stati Uniti, 91790
- Reclutamento
- Kinetic Clinical Research
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West Hills, California, Stati Uniti, 91307
- Reclutamento
- Focus Clinical Research
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Colorado
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Centennial, Colorado, Stati Uniti, 80112
- Reclutamento
- IMMUNOe Research Centers
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Colorado Springs, Colorado, Stati Uniti, 80910
- Reclutamento
- MCB Clinical Research Centers
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Fort Collins, Colorado, Stati Uniti, 80528
- Reclutamento
- Advanced Neurosciences Research
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Connecticut
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Waterbury, Connecticut, Stati Uniti, 06708
- Reclutamento
- Chase Medical Research, LLC
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Georgia
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Atlanta, Georgia, Stati Uniti, 30329
- Reclutamento
- DelRicht Research
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Marietta, Georgia, Stati Uniti, 30060
- Reclutamento
- Drug Studies America
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Stockbridge, Georgia, Stati Uniti, 30281
- Reclutamento
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Illinois
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Chicago, Illinois, Stati Uniti, 60607
- Reclutamento
- Cedar Crosse Research Center
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Chicago, Illinois, Stati Uniti, 60657
- Reclutamento
- Chicago Headache Center & Research Institute
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Flossmoor, Illinois, Stati Uniti, 60447
- Reclutamento
- Healthcare Research Network II, LLC
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Naperville, Illinois, Stati Uniti, 60563
- Reclutamento
- Chicago Headache Center & Research Institute
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Iowa
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West Des Moines, Iowa, Stati Uniti, 50265
- Reclutamento
- Integrated Clinical Trials Solution
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Kansas
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Overland Park, Kansas, Stati Uniti, 66214
- Reclutamento
- Clinical Associates Midwest, LLC
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Overland Park, Kansas, Stati Uniti, 66212
- Reclutamento
- Collective Medical Research
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Wichita, Kansas, Stati Uniti, 67207
- Reclutamento
- Heartland Research Associates, LLC - An AMR Company
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Kentucky
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Bardstown, Kentucky, Stati Uniti, 40004
- Reclutamento
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Lexington, Kentucky, Stati Uniti, 40509
- Reclutamento
- AMR Clinical - Lexington
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Lexington, Kentucky, Stati Uniti, 45212
- Reclutamento
- CTI Clinical Research Center
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Louisiana
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Chalmette, Louisiana, Stati Uniti, 70043
- Reclutamento
- Crescent City Headache & Neurology Center
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New Orleans, Louisiana, Stati Uniti, 70115
- Reclutamento
- DelRicht Research
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Maryland
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Pikesville, Maryland, Stati Uniti, 21208
- Reclutamento
- Headlands Research - Pharmasite
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02131
- Reclutamento
- Boston Clinical Trials - Alcanza
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Waltham, Massachusetts, Stati Uniti, 02451
- Reclutamento
- MedVadis Research Corporation, LLC
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48104
- Reclutamento
- Michigan Headache Pain & Neurological Institute
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55402
- Reclutamento
- Clinical Research Institute
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Mississippi
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Gulfport, Mississippi, Stati Uniti, 39503
- Reclutamento
- DelRicht Research
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Ridgeland, Mississippi, Stati Uniti, 39157
- Reclutamento
- Proven Endpoints
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Missouri
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City of Saint Peters, Missouri, Stati Uniti, 63303
- Reclutamento
- StudyMetrix Research
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Hazelwood, Missouri, Stati Uniti, 63042
- Reclutamento
- Healthcare Research Network
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Kansas City, Missouri, Stati Uniti, 64114
- Reclutamento
- AMR Clinical - Kansas City
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Springfield, Missouri, Stati Uniti, 65807
- Reclutamento
- Clinvest Headlands Llc
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St Louis, Missouri, Stati Uniti, 63141
- Reclutamento
- Sundance Clinical Research
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89109
- Reclutamento
- Excel Clinical Research
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Las Vegas, Nevada, Stati Uniti, 89119
- Reclutamento
- Redbird Research
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Las Vegas, Nevada, Stati Uniti, 89102
- Reclutamento
- Ima Clinical Research - Las Vegas
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Las Vegas, Nevada, Stati Uniti, 89118
- Reclutamento
- Wake Research Las Vegas Rainbow
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Las Vegas, Nevada, Stati Uniti, 89119
- Reclutamento
- AMR Clinical - Las Vegas
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North Las Vegas, Nevada, Stati Uniti, 89030
- Reclutamento
- Las Vegas Clinical Trials
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Reno, Nevada, Stati Uniti, 89511
- Reclutamento
- Advanced Research Institute-Reno
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
- Reclutamento
- Albuquerque Clinical Trials
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New York
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Amherst, New York, Stati Uniti, 14226
- Reclutamento
- Dent Neuro Institute, Buffalo
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Brooklyn, New York, Stati Uniti, 11235
- Reclutamento
- SPRI Clinical Trials, LLC
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Commack, New York, Stati Uniti, 11725
- Reclutamento
- True North Neurology
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Manlius, New York, Stati Uniti, 13104
- Reclutamento
- Central New York Clinical Research
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New York, New York, Stati Uniti, 10017
- Reclutamento
- Fieve Clinical Research, Inc
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Rochester, New York, Stati Uniti, 14609
- Reclutamento
- Rochester Clinical Research
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Williamsville, New York, Stati Uniti, 14221
- Reclutamento
- Upstate Clinical Research Associates
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28277
- Reclutamento
- Onsite Clinical Solutions
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Greensboro, North Carolina, Stati Uniti, 27405
- Reclutamento
- Headache Wellness Center
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Greensboro, North Carolina, Stati Uniti, 27405
- Reclutamento
- Guilford Neurologic Research Partners, LLC
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Raleigh, North Carolina, Stati Uniti, 27607
- Reclutamento
- Eximia Research - NC, LLC
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Shelby, North Carolina, Stati Uniti, 28150
- Reclutamento
- Carolina Research Center, Inc
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Ohio
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Columbus, Ohio, Stati Uniti, 43228
- Reclutamento
- Hometown Research
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Milford, Ohio, Stati Uniti, 45150
- Reclutamento
- Hometown Research
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West Chester, Ohio, Stati Uniti, 45069
- Reclutamento
- CincyScience
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Oklahoma
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Edmond, Oklahoma, Stati Uniti, 73034
- Reclutamento
- OK Clinical Research, LLC
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Oklahoma City, Oklahoma, Stati Uniti, 73102
- Reclutamento
- Hightower Clinical
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Tulsa, Oklahoma, Stati Uniti, 74133
- Reclutamento
- DelRicht Research
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Yukon, Oklahoma, Stati Uniti, 73099
- Reclutamento
- Tekton Research, Inc.
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Oregon
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Portland, Oregon, Stati Uniti, 97210
- Reclutamento
- Summit Research Network
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Portland, Oregon, Stati Uniti, 97223
- Reclutamento
- Advanced Research Institute-Portland
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Pennsylvania
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Allentown, Pennsylvania, Stati Uniti, 18103
- Reclutamento
- Lehigh Center For Clinical Research
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Philadelphia, Pennsylvania, Stati Uniti, 19114
- Reclutamento
- Clinical Research Philadelphia
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Pittsburgh, Pennsylvania, Stati Uniti, 15236
- Reclutamento
- Preferred Primary Care Physicians, Inc.
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Scottdale, Pennsylvania, Stati Uniti, 15683
- Reclutamento
- Frontier Clinical Research, LLC
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Smithfield, Pennsylvania, Stati Uniti, 15478
- Reclutamento
- Frontier Clinical Research, LLC
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South Carolina
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North Charleston, South Carolina, Stati Uniti, 29405
- Reclutamento
- Coastal Carolina Research Center
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37421
- Reclutamento
- WR-ClinSearch, LLC
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Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- Clinical Research Associates, Inc.
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Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- Access Clinical Trials Inc
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Texas
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Austin, Texas, Stati Uniti, 78731
- Reclutamento
- FutureSearch Trials of Neurology
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Austin, Texas, Stati Uniti, 78745
- Reclutamento
- Tekton Research
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Cypress, Texas, Stati Uniti, 77372
- Reclutamento
- APD Clinical Research
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Cypress, Texas, Stati Uniti, 77429
- Reclutamento
- Horizon Clinical Research and Gill Neuroscience
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Dallas, Texas, Stati Uniti, 75251
- Reclutamento
- FutureSearch Trials of Dallas, LP
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Houston, Texas, Stati Uniti, 77081
- Reclutamento
- DM Clinical Research
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Houston, Texas, Stati Uniti, 77024
- Reclutamento
- Victorium Clinical Research
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Lampasas, Texas, Stati Uniti, 76550
- Reclutamento
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Plano, Texas, Stati Uniti, 75093
- Reclutamento
- AIM Trials, LLC
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Waxahachie, Texas, Stati Uniti, 75165
- Reclutamento
- ClinPoint Trials
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Utah
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Bountiful, Utah, Stati Uniti, 84010
- Reclutamento
- Pantheon Clinical Research
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Draper, Utah, Stati Uniti, 84020
- Reclutamento
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Ogden, Utah, Stati Uniti, 84405
- Reclutamento
- Advanced Research Institute
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Riverton, Utah, Stati Uniti, 84096
- Reclutamento
- Granger Medical Clinic
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Salt Lake City, Utah, Stati Uniti, 84109
- Reclutamento
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Stati Uniti, 84121
- Reclutamento
- J. Lewis Research, Inc. / Foothill Family Clinic
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Virginia
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Newport News, Virginia, Stati Uniti, 23606
- Reclutamento
- Health Research of Hampton Roads, Inc. (HRHR)
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Norfolk, Virginia, Stati Uniti, 23502
- Reclutamento
- AMR Clinical - Norfolk
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Washington
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Seattle, Washington, Stati Uniti, 98104
- Reclutamento
- Seattle Clinical Research Center
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West Virginia
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Morgantown, West Virginia, Stati Uniti, 26505
- Reclutamento
- Frontier Clinical Research
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Wisconsin
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Kenosha, Wisconsin, Stati Uniti, 53144
- Reclutamento
- Clinical Investigation Specialists, Inc.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Elismetrep 10 mg
|
Somministrato per via orale
Administered orally
Altri nomi:
|
|
Sperimentale: Elismetrep 20 mg
|
Administered orally
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Proportion of participants with at least one treatment-emergent adverse event (TEAE)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
3 agosto 2026
Completamento primario (Stimato)
1 giugno 2028
Completamento dello studio (Stimato)
1 giugno 2028
Date di iscrizione allo studio
Primo inviato
15 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
23 giugno 2026
Primo Inserito (Effettivo)
29 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- K-304 P005
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .