A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
26. august 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1000
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Annemarie Vance
- Telefonnummer: 917-336-3654
- E-mail: annemarie@kallyope.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
- Rekruttering
- Central Research Associates, LLC (CRA) dba Flourish Research
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Mobile, Alabama, Forenede Stater, 36608
- Rekruttering
- AMR Mobile
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Arizona
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Chandler, Arizona, Forenede Stater, 85286
- Rekruttering
- TrialSphere
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Rekruttering
- Arkansas Clinical Research
-
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California
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Colton, California, Forenede Stater, 92324
- Rekruttering
- Axiom Research, LLC
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Culver City, California, Forenede Stater, 90230
- Rekruttering
- Proscience Research Group
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Encino, California, Forenede Stater, 91316
- Rekruttering
- Leading Edge Research LA, LLC
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Irvine, California, Forenede Stater, 92604
- Rekruttering
- Axiom Research, Orange County
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Los Angeles, California, Forenede Stater, 90048
- Rekruttering
- Clinical Research Institute
-
Los Angeles, California, Forenede Stater, 90017
- Rekruttering
- Downtown L.A. Research Center, Inc.
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Mission Viejo, California, Forenede Stater, 92691
- Rekruttering
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Oceanside, California, Forenede Stater, 92056
- Rekruttering
- Excell Research
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Pomona, California, Forenede Stater, 91767
- Rekruttering
- The Neurology Group
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Pomona, California, Forenede Stater, 91767
- Rekruttering
- Empire Clinical Research
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Riverside, California, Forenede Stater, 92503
- Rekruttering
- Artemis Institute for Clinical Research
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San Diego, California, Forenede Stater, 92120
- Rekruttering
- Acclaim Clinical Research
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Sherman Oaks, California, Forenede Stater, 91403
- Rekruttering
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Spring Valley, California, Forenede Stater, 91978
- Rekruttering
- Encompass Clinical Research
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Walnut Creek, California, Forenede Stater, 94598
- Rekruttering
- Diablo Clinical Research
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Walnut Creek, California, Forenede Stater, 94596
- Rekruttering
- Sunwise Clinical Research
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West Covina, California, Forenede Stater, 91790
- Rekruttering
- Kinetic Clinical Research
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West Hills, California, Forenede Stater, 91307
- Rekruttering
- Focus Clinical Research
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Colorado
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Centennial, Colorado, Forenede Stater, 80112
- Rekruttering
- IMMUNOe Research Centers
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Colorado Springs, Colorado, Forenede Stater, 80910
- Rekruttering
- MCB Clinical Research Centers
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Fort Collins, Colorado, Forenede Stater, 80528
- Rekruttering
- Advanced Neurosciences Research
-
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Connecticut
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Waterbury, Connecticut, Forenede Stater, 06708
- Rekruttering
- Chase Medical Research, LLC
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Georgia
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Atlanta, Georgia, Forenede Stater, 30329
- Rekruttering
- DelRicht Research
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Marietta, Georgia, Forenede Stater, 30060
- Rekruttering
- Drug Studies America
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Stockbridge, Georgia, Forenede Stater, 30281
- Rekruttering
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
-
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Illinois
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Chicago, Illinois, Forenede Stater, 60607
- Rekruttering
- Cedar Crosse Research Center
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Chicago, Illinois, Forenede Stater, 60657
- Rekruttering
- Chicago Headache Center & Research Institute
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Flossmoor, Illinois, Forenede Stater, 60447
- Rekruttering
- Healthcare Research Network II, LLC
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Naperville, Illinois, Forenede Stater, 60563
- Rekruttering
- Chicago Headache Center & Research Institute
-
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Iowa
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West Des Moines, Iowa, Forenede Stater, 50265
- Rekruttering
- Integrated Clinical Trials Solution
-
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Kansas
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Overland Park, Kansas, Forenede Stater, 66214
- Rekruttering
- Clinical Associates Midwest, LLC
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Overland Park, Kansas, Forenede Stater, 66212
- Rekruttering
- Collective Medical Research
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Wichita, Kansas, Forenede Stater, 67207
- Rekruttering
- Heartland Research Associates, LLC - An AMR Company
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Kentucky
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Bardstown, Kentucky, Forenede Stater, 40004
- Rekruttering
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Lexington, Kentucky, Forenede Stater, 40509
- Rekruttering
- AMR Clinical - Lexington
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Lexington, Kentucky, Forenede Stater, 45212
- Rekruttering
- CTI Clinical Research Center
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Louisiana
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Chalmette, Louisiana, Forenede Stater, 70043
- Rekruttering
- Crescent City Headache & Neurology Center
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New Orleans, Louisiana, Forenede Stater, 70115
- Rekruttering
- DelRicht Research
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Maryland
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Pikesville, Maryland, Forenede Stater, 21208
- Rekruttering
- Headlands Research - Pharmasite
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02131
- Rekruttering
- Boston Clinical Trials - Alcanza
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Waltham, Massachusetts, Forenede Stater, 02451
- Rekruttering
- MedVadis Research Corporation, LLC
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48104
- Rekruttering
- Michigan Headache Pain & Neurological Institute
-
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55402
- Rekruttering
- Clinical Research Institute
-
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Mississippi
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Gulfport, Mississippi, Forenede Stater, 39503
- Rekruttering
- DelRicht Research
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Ridgeland, Mississippi, Forenede Stater, 39157
- Rekruttering
- Proven Endpoints
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Missouri
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City of Saint Peters, Missouri, Forenede Stater, 63303
- Rekruttering
- StudyMetrix Research
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Hazelwood, Missouri, Forenede Stater, 63042
- Rekruttering
- Healthcare Research Network
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Kansas City, Missouri, Forenede Stater, 64114
- Rekruttering
- AMR Clinical - Kansas City
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Springfield, Missouri, Forenede Stater, 65807
- Rekruttering
- Clinvest Headlands Llc
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St Louis, Missouri, Forenede Stater, 63141
- Rekruttering
- Sundance Clinical Research
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109
- Rekruttering
- Excel Clinical Research
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Las Vegas, Nevada, Forenede Stater, 89119
- Rekruttering
- Redbird Research
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Las Vegas, Nevada, Forenede Stater, 89102
- Rekruttering
- Ima Clinical Research - Las Vegas
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Las Vegas, Nevada, Forenede Stater, 89118
- Rekruttering
- Wake Research Las Vegas Rainbow
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Las Vegas, Nevada, Forenede Stater, 89119
- Rekruttering
- AMR Clinical - Las Vegas
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North Las Vegas, Nevada, Forenede Stater, 89030
- Rekruttering
- Las Vegas Clinical Trials
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Reno, Nevada, Forenede Stater, 89511
- Rekruttering
- Advanced Research Institute-Reno
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Rekruttering
- Albuquerque Clinical Trials
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New York
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Amherst, New York, Forenede Stater, 14226
- Rekruttering
- Dent Neuro Institute, Buffalo
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Brooklyn, New York, Forenede Stater, 11235
- Rekruttering
- SPRI Clinical Trials, LLC
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Commack, New York, Forenede Stater, 11725
- Rekruttering
- True North Neurology
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Manlius, New York, Forenede Stater, 13104
- Rekruttering
- Central New York Clinical Research
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New York, New York, Forenede Stater, 10017
- Rekruttering
- Fieve Clinical Research, Inc
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Rochester, New York, Forenede Stater, 14609
- Rekruttering
- Rochester Clinical Research
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Williamsville, New York, Forenede Stater, 14221
- Rekruttering
- Upstate Clinical Research Associates
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28277
- Rekruttering
- Onsite Clinical Solutions
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Greensboro, North Carolina, Forenede Stater, 27405
- Rekruttering
- Headache Wellness Center
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Greensboro, North Carolina, Forenede Stater, 27405
- Rekruttering
- Guilford Neurologic Research Partners, LLC
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Raleigh, North Carolina, Forenede Stater, 27607
- Rekruttering
- Eximia Research - NC, LLC
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Shelby, North Carolina, Forenede Stater, 28150
- Rekruttering
- Carolina Research Center, Inc
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Ohio
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Columbus, Ohio, Forenede Stater, 43228
- Rekruttering
- Hometown Research
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Milford, Ohio, Forenede Stater, 45150
- Rekruttering
- Hometown Research
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West Chester, Ohio, Forenede Stater, 45069
- Rekruttering
- CincyScience
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Oklahoma
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Edmond, Oklahoma, Forenede Stater, 73034
- Rekruttering
- OK Clinical Research, LLC
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Oklahoma City, Oklahoma, Forenede Stater, 73102
- Rekruttering
- Hightower Clinical
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Tulsa, Oklahoma, Forenede Stater, 74133
- Rekruttering
- DelRicht Research
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Yukon, Oklahoma, Forenede Stater, 73099
- Rekruttering
- Tekton Research, Inc.
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- Rekruttering
- Summit Research Network
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Portland, Oregon, Forenede Stater, 97223
- Rekruttering
- Advanced Research Institute-Portland
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18103
- Rekruttering
- Lehigh Center For Clinical Research
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Philadelphia, Pennsylvania, Forenede Stater, 19114
- Rekruttering
- Clinical Research Philadelphia
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Pittsburgh, Pennsylvania, Forenede Stater, 15236
- Rekruttering
- Preferred Primary Care Physicians, Inc.
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Scottdale, Pennsylvania, Forenede Stater, 15683
- Rekruttering
- Frontier Clinical Research, LLC
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Smithfield, Pennsylvania, Forenede Stater, 15478
- Rekruttering
- Frontier Clinical Research, LLC
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South Carolina
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North Charleston, South Carolina, Forenede Stater, 29405
- Rekruttering
- Coastal Carolina Research Center
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37421
- Rekruttering
- WR-ClinSearch, LLC
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Clinical Research Associates, Inc.
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Access Clinical Trials Inc
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Texas
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Austin, Texas, Forenede Stater, 78731
- Rekruttering
- FutureSearch Trials of Neurology
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Austin, Texas, Forenede Stater, 78745
- Rekruttering
- Tekton Research
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Cypress, Texas, Forenede Stater, 77372
- Rekruttering
- APD Clinical Research
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Cypress, Texas, Forenede Stater, 77429
- Rekruttering
- Horizon Clinical Research and Gill Neuroscience
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Dallas, Texas, Forenede Stater, 75251
- Rekruttering
- FutureSearch Trials of Dallas, LP
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Houston, Texas, Forenede Stater, 77081
- Rekruttering
- DM Clinical Research
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Houston, Texas, Forenede Stater, 77024
- Rekruttering
- Victorium Clinical Research
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Lampasas, Texas, Forenede Stater, 76550
- Rekruttering
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Plano, Texas, Forenede Stater, 75093
- Rekruttering
- AIM Trials, LLC
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Waxahachie, Texas, Forenede Stater, 75165
- Rekruttering
- ClinPoint Trials
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Utah
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Bountiful, Utah, Forenede Stater, 84010
- Rekruttering
- Pantheon Clinical Research
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Draper, Utah, Forenede Stater, 84020
- Rekruttering
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Ogden, Utah, Forenede Stater, 84405
- Rekruttering
- Advanced Research Institute
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Riverton, Utah, Forenede Stater, 84096
- Rekruttering
- Granger Medical Clinic
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Salt Lake City, Utah, Forenede Stater, 84109
- Rekruttering
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Forenede Stater, 84121
- Rekruttering
- J. Lewis Research, Inc. / Foothill Family Clinic
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Virginia
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Newport News, Virginia, Forenede Stater, 23606
- Rekruttering
- Health Research of Hampton Roads, Inc. (HRHR)
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Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- AMR Clinical - Norfolk
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Seattle Clinical Research Center
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26505
- Rekruttering
- Frontier Clinical Research
-
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Wisconsin
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Kenosha, Wisconsin, Forenede Stater, 53144
- Rekruttering
- Clinical Investigation Specialists, Inc.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Elismetrep 10 mg
|
Indgives oralt
Administered orally
Andre navne:
|
|
Eksperimentel: Elismetrep 20 mg
|
Administered orally
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of participants with at least one treatment-emergent adverse event (TEAE)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. august 2026
Primær færdiggørelse (Anslået)
1. juni 2028
Studieafslutning (Anslået)
1. juni 2028
Datoer for studieregistrering
Først indsendt
15. juni 2026
Først indsendt, der opfyldte QC-kriterier
23. juni 2026
Først opslået (Faktiske)
29. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- K-304 P005
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .