A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
26 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
1000
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Annemarie Vance
- Telefonnummer: 917-336-3654
- E-post: annemarie@kallyope.com
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35205
- Rekrytering
- Central Research Associates, LLC (CRA) dba Flourish Research
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Mobile, Alabama, Förenta staterna, 36608
- Rekrytering
- AMR Mobile
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Arizona
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Chandler, Arizona, Förenta staterna, 85286
- Rekrytering
- TrialSphere
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- Rekrytering
- Arkansas Clinical Research
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California
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Colton, California, Förenta staterna, 92324
- Rekrytering
- Axiom Research, LLC
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Culver City, California, Förenta staterna, 90230
- Rekrytering
- Proscience Research Group
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Encino, California, Förenta staterna, 91316
- Rekrytering
- Leading Edge Research LA, LLC
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Irvine, California, Förenta staterna, 92604
- Rekrytering
- Axiom Research, Orange County
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Los Angeles, California, Förenta staterna, 90048
- Rekrytering
- Clinical Research Institute
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Los Angeles, California, Förenta staterna, 90017
- Rekrytering
- Downtown L.A. Research Center, Inc.
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Mission Viejo, California, Förenta staterna, 92691
- Rekrytering
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Oceanside, California, Förenta staterna, 92056
- Rekrytering
- Excell Research
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Pomona, California, Förenta staterna, 91767
- Rekrytering
- The Neurology Group
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Pomona, California, Förenta staterna, 91767
- Rekrytering
- Empire Clinical Research
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Riverside, California, Förenta staterna, 92503
- Rekrytering
- Artemis Institute for Clinical Research
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San Diego, California, Förenta staterna, 92120
- Rekrytering
- Acclaim Clinical Research
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Sherman Oaks, California, Förenta staterna, 91403
- Rekrytering
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Spring Valley, California, Förenta staterna, 91978
- Rekrytering
- Encompass Clinical Research
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Walnut Creek, California, Förenta staterna, 94598
- Rekrytering
- Diablo Clinical Research
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Walnut Creek, California, Förenta staterna, 94596
- Rekrytering
- Sunwise Clinical Research
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West Covina, California, Förenta staterna, 91790
- Rekrytering
- Kinetic Clinical Research
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West Hills, California, Förenta staterna, 91307
- Rekrytering
- Focus Clinical Research
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Colorado
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Centennial, Colorado, Förenta staterna, 80112
- Rekrytering
- IMMUNOe Research Centers
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Colorado Springs, Colorado, Förenta staterna, 80910
- Rekrytering
- MCB Clinical Research Centers
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Fort Collins, Colorado, Förenta staterna, 80528
- Rekrytering
- Advanced Neurosciences Research
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Connecticut
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Waterbury, Connecticut, Förenta staterna, 06708
- Rekrytering
- Chase Medical Research, LLC
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Georgia
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Atlanta, Georgia, Förenta staterna, 30329
- Rekrytering
- DelRicht Research
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Marietta, Georgia, Förenta staterna, 30060
- Rekrytering
- Drug Studies America
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Stockbridge, Georgia, Förenta staterna, 30281
- Rekrytering
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Illinois
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Chicago, Illinois, Förenta staterna, 60607
- Rekrytering
- Cedar Crosse Research Center
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Chicago, Illinois, Förenta staterna, 60657
- Rekrytering
- Chicago Headache Center & Research Institute
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Flossmoor, Illinois, Förenta staterna, 60447
- Rekrytering
- Healthcare Research Network II, LLC
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Naperville, Illinois, Förenta staterna, 60563
- Rekrytering
- Chicago Headache Center & Research Institute
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Iowa
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West Des Moines, Iowa, Förenta staterna, 50265
- Rekrytering
- Integrated Clinical Trials Solution
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Kansas
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Overland Park, Kansas, Förenta staterna, 66214
- Rekrytering
- Clinical Associates Midwest, LLC
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Overland Park, Kansas, Förenta staterna, 66212
- Rekrytering
- Collective Medical Research
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Wichita, Kansas, Förenta staterna, 67207
- Rekrytering
- Heartland Research Associates, LLC - An AMR Company
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Kentucky
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Bardstown, Kentucky, Förenta staterna, 40004
- Rekrytering
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Lexington, Kentucky, Förenta staterna, 40509
- Rekrytering
- AMR Clinical - Lexington
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Lexington, Kentucky, Förenta staterna, 45212
- Rekrytering
- CTI Clinical Research Center
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Louisiana
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Chalmette, Louisiana, Förenta staterna, 70043
- Rekrytering
- Crescent City Headache & Neurology Center
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New Orleans, Louisiana, Förenta staterna, 70115
- Rekrytering
- DelRicht Research
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Maryland
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Pikesville, Maryland, Förenta staterna, 21208
- Rekrytering
- Headlands Research - Pharmasite
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02131
- Rekrytering
- Boston Clinical Trials - Alcanza
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Waltham, Massachusetts, Förenta staterna, 02451
- Rekrytering
- MedVadis Research Corporation, LLC
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48104
- Rekrytering
- Michigan Headache Pain & Neurological Institute
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55402
- Rekrytering
- Clinical Research Institute
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Mississippi
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Gulfport, Mississippi, Förenta staterna, 39503
- Rekrytering
- DelRicht Research
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Ridgeland, Mississippi, Förenta staterna, 39157
- Rekrytering
- Proven Endpoints
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Missouri
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City of Saint Peters, Missouri, Förenta staterna, 63303
- Rekrytering
- StudyMetrix Research
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Hazelwood, Missouri, Förenta staterna, 63042
- Rekrytering
- Healthcare Research Network
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Kansas City, Missouri, Förenta staterna, 64114
- Rekrytering
- AMR Clinical - Kansas City
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Springfield, Missouri, Förenta staterna, 65807
- Rekrytering
- Clinvest Headlands Llc
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St Louis, Missouri, Förenta staterna, 63141
- Rekrytering
- Sundance Clinical Research
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89109
- Rekrytering
- Excel Clinical Research
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Las Vegas, Nevada, Förenta staterna, 89119
- Rekrytering
- Redbird Research
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Las Vegas, Nevada, Förenta staterna, 89102
- Rekrytering
- Ima Clinical Research - Las Vegas
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Las Vegas, Nevada, Förenta staterna, 89118
- Rekrytering
- Wake Research Las Vegas Rainbow
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Las Vegas, Nevada, Förenta staterna, 89119
- Rekrytering
- AMR Clinical - Las Vegas
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North Las Vegas, Nevada, Förenta staterna, 89030
- Rekrytering
- Las Vegas Clinical Trials
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Reno, Nevada, Förenta staterna, 89511
- Rekrytering
- Advanced Research Institute-Reno
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87102
- Rekrytering
- Albuquerque Clinical Trials
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New York
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Amherst, New York, Förenta staterna, 14226
- Rekrytering
- Dent Neuro Institute, Buffalo
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Brooklyn, New York, Förenta staterna, 11235
- Rekrytering
- SPRI Clinical Trials, LLC
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Commack, New York, Förenta staterna, 11725
- Rekrytering
- True North Neurology
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Manlius, New York, Förenta staterna, 13104
- Rekrytering
- Central New York Clinical Research
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New York, New York, Förenta staterna, 10017
- Rekrytering
- Fieve Clinical Research, Inc
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Rochester, New York, Förenta staterna, 14609
- Rekrytering
- Rochester Clinical Research
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Williamsville, New York, Förenta staterna, 14221
- Rekrytering
- Upstate Clinical Research Associates
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28277
- Rekrytering
- Onsite Clinical Solutions
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Greensboro, North Carolina, Förenta staterna, 27405
- Rekrytering
- Headache Wellness Center
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Greensboro, North Carolina, Förenta staterna, 27405
- Rekrytering
- Guilford Neurologic Research Partners, LLC
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Raleigh, North Carolina, Förenta staterna, 27607
- Rekrytering
- Eximia Research - NC, LLC
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Shelby, North Carolina, Förenta staterna, 28150
- Rekrytering
- Carolina Research Center, Inc
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Ohio
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Columbus, Ohio, Förenta staterna, 43228
- Rekrytering
- Hometown Research
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Milford, Ohio, Förenta staterna, 45150
- Rekrytering
- Hometown Research
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West Chester, Ohio, Förenta staterna, 45069
- Rekrytering
- CincyScience
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Oklahoma
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Edmond, Oklahoma, Förenta staterna, 73034
- Rekrytering
- OK Clinical Research, LLC
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Oklahoma City, Oklahoma, Förenta staterna, 73102
- Rekrytering
- Hightower Clinical
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Tulsa, Oklahoma, Förenta staterna, 74133
- Rekrytering
- DelRicht Research
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Yukon, Oklahoma, Förenta staterna, 73099
- Rekrytering
- Tekton Research, Inc.
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Oregon
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Portland, Oregon, Förenta staterna, 97210
- Rekrytering
- Summit Research Network
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Portland, Oregon, Förenta staterna, 97223
- Rekrytering
- Advanced Research Institute-Portland
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Pennsylvania
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Allentown, Pennsylvania, Förenta staterna, 18103
- Rekrytering
- Lehigh Center For Clinical Research
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Philadelphia, Pennsylvania, Förenta staterna, 19114
- Rekrytering
- Clinical Research Philadelphia
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Pittsburgh, Pennsylvania, Förenta staterna, 15236
- Rekrytering
- Preferred Primary Care Physicians, Inc.
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Scottdale, Pennsylvania, Förenta staterna, 15683
- Rekrytering
- Frontier Clinical Research, LLC
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Smithfield, Pennsylvania, Förenta staterna, 15478
- Rekrytering
- Frontier Clinical Research, LLC
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South Carolina
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North Charleston, South Carolina, Förenta staterna, 29405
- Rekrytering
- Coastal Carolina Research Center
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Tennessee
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Chattanooga, Tennessee, Förenta staterna, 37421
- Rekrytering
- WR-ClinSearch, LLC
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Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- Clinical Research Associates, Inc.
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Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- Access Clinical Trials Inc
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Texas
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Austin, Texas, Förenta staterna, 78731
- Rekrytering
- FutureSearch Trials of Neurology
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Austin, Texas, Förenta staterna, 78745
- Rekrytering
- Tekton Research
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Cypress, Texas, Förenta staterna, 77372
- Rekrytering
- APD Clinical Research
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Cypress, Texas, Förenta staterna, 77429
- Rekrytering
- Horizon Clinical Research and Gill Neuroscience
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Dallas, Texas, Förenta staterna, 75251
- Rekrytering
- FutureSearch Trials of Dallas, LP
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Houston, Texas, Förenta staterna, 77081
- Rekrytering
- DM Clinical Research
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Houston, Texas, Förenta staterna, 77024
- Rekrytering
- Victorium Clinical Research
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Lampasas, Texas, Förenta staterna, 76550
- Rekrytering
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Plano, Texas, Förenta staterna, 75093
- Rekrytering
- AIM Trials, LLC
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Waxahachie, Texas, Förenta staterna, 75165
- Rekrytering
- ClinPoint Trials
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Utah
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Bountiful, Utah, Förenta staterna, 84010
- Rekrytering
- Pantheon Clinical Research
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Draper, Utah, Förenta staterna, 84020
- Rekrytering
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Ogden, Utah, Förenta staterna, 84405
- Rekrytering
- Advanced Research Institute
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Riverton, Utah, Förenta staterna, 84096
- Rekrytering
- Granger Medical Clinic
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Salt Lake City, Utah, Förenta staterna, 84109
- Rekrytering
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Förenta staterna, 84121
- Rekrytering
- J. Lewis Research, Inc. / Foothill Family Clinic
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Virginia
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Newport News, Virginia, Förenta staterna, 23606
- Rekrytering
- Health Research of Hampton Roads, Inc. (HRHR)
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Norfolk, Virginia, Förenta staterna, 23502
- Rekrytering
- AMR Clinical - Norfolk
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Washington
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Seattle, Washington, Förenta staterna, 98104
- Rekrytering
- Seattle Clinical Research Center
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West Virginia
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Morgantown, West Virginia, Förenta staterna, 26505
- Rekrytering
- Frontier Clinical Research
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Wisconsin
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Kenosha, Wisconsin, Förenta staterna, 53144
- Rekrytering
- Clinical Investigation Specialists, Inc.
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Elismetrep 10 mg
|
Administreras oralt
Administered orally
Andra namn:
|
|
Experimentell: Elismetrep 20 mg
|
Administered orally
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Proportion of participants with at least one treatment-emergent adverse event (TEAE)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 augusti 2026
Primärt slutförande (Beräknad)
1 juni 2028
Avslutad studie (Beräknad)
1 juni 2028
Studieregistreringsdatum
Först inskickad
15 juni 2026
Först inskickad som uppfyllde QC-kriterierna
23 juni 2026
Första postat (Faktisk)
29 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- K-304 P005
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .