A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
26 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
1000
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Annemarie Vance
- Telefoonnummer: 917-336-3654
- E-mail: annemarie@kallyope.com
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35205
- Werving
- Central Research Associates, LLC (CRA) dba Flourish Research
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Mobile, Alabama, Verenigde Staten, 36608
- Werving
- AMR Mobile
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Arizona
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Chandler, Arizona, Verenigde Staten, 85286
- Werving
- TrialSphere
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
- Werving
- Arkansas Clinical Research
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California
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Colton, California, Verenigde Staten, 92324
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- Axiom Research, LLC
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Culver City, California, Verenigde Staten, 90230
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- Proscience Research Group
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Encino, California, Verenigde Staten, 91316
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- Leading Edge Research LA, LLC
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Irvine, California, Verenigde Staten, 92604
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- Axiom Research, Orange County
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Los Angeles, California, Verenigde Staten, 90048
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- Clinical Research Institute
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Los Angeles, California, Verenigde Staten, 90017
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- Downtown L.A. Research Center, Inc.
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Mission Viejo, California, Verenigde Staten, 92691
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- M3 Wake Research - Mission Mental Health (WR-MMH)
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Oceanside, California, Verenigde Staten, 92056
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- Excell Research
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Pomona, California, Verenigde Staten, 91767
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- The Neurology Group
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Pomona, California, Verenigde Staten, 91767
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- Empire Clinical Research
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Riverside, California, Verenigde Staten, 92503
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- Artemis Institute for Clinical Research
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San Diego, California, Verenigde Staten, 92120
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- Acclaim Clinical Research
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Sherman Oaks, California, Verenigde Staten, 91403
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- CenExel Sherman Oaks CA (California Neuroscience Research)
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Spring Valley, California, Verenigde Staten, 91978
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- Encompass Clinical Research
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Walnut Creek, California, Verenigde Staten, 94598
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- Diablo Clinical Research
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Walnut Creek, California, Verenigde Staten, 94596
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- Sunwise Clinical Research
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West Covina, California, Verenigde Staten, 91790
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- Kinetic Clinical Research
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West Hills, California, Verenigde Staten, 91307
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- Focus Clinical Research
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Colorado
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Centennial, Colorado, Verenigde Staten, 80112
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- IMMUNOe Research Centers
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Colorado Springs, Colorado, Verenigde Staten, 80910
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- MCB Clinical Research Centers
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Fort Collins, Colorado, Verenigde Staten, 80528
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- Advanced Neurosciences Research
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Connecticut
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Waterbury, Connecticut, Verenigde Staten, 06708
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- Chase Medical Research, LLC
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30329
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- DelRicht Research
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Marietta, Georgia, Verenigde Staten, 30060
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- Drug Studies America
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Stockbridge, Georgia, Verenigde Staten, 30281
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- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Illinois
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Chicago, Illinois, Verenigde Staten, 60607
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- Cedar Crosse Research Center
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Chicago, Illinois, Verenigde Staten, 60657
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- Chicago Headache Center & Research Institute
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Flossmoor, Illinois, Verenigde Staten, 60447
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- Healthcare Research Network II, LLC
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Naperville, Illinois, Verenigde Staten, 60563
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- Chicago Headache Center & Research Institute
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Iowa
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West Des Moines, Iowa, Verenigde Staten, 50265
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- Integrated Clinical Trials Solution
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Kansas
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Overland Park, Kansas, Verenigde Staten, 66214
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- Clinical Associates Midwest, LLC
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Overland Park, Kansas, Verenigde Staten, 66212
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- Collective Medical Research
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Wichita, Kansas, Verenigde Staten, 67207
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- Heartland Research Associates, LLC - An AMR Company
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Kentucky
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Bardstown, Kentucky, Verenigde Staten, 40004
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- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Lexington, Kentucky, Verenigde Staten, 40509
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- AMR Clinical - Lexington
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Lexington, Kentucky, Verenigde Staten, 45212
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- CTI Clinical Research Center
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Louisiana
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Chalmette, Louisiana, Verenigde Staten, 70043
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- Crescent City Headache & Neurology Center
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New Orleans, Louisiana, Verenigde Staten, 70115
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- DelRicht Research
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Maryland
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Pikesville, Maryland, Verenigde Staten, 21208
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- Headlands Research - Pharmasite
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02131
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- Boston Clinical Trials - Alcanza
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Waltham, Massachusetts, Verenigde Staten, 02451
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- MedVadis Research Corporation, LLC
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48104
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- Michigan Headache Pain & Neurological Institute
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55402
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- Clinical Research Institute
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Mississippi
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Gulfport, Mississippi, Verenigde Staten, 39503
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- DelRicht Research
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Ridgeland, Mississippi, Verenigde Staten, 39157
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- Proven Endpoints
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Missouri
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City of Saint Peters, Missouri, Verenigde Staten, 63303
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- StudyMetrix Research
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Hazelwood, Missouri, Verenigde Staten, 63042
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- Healthcare Research Network
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Kansas City, Missouri, Verenigde Staten, 64114
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- AMR Clinical - Kansas City
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Springfield, Missouri, Verenigde Staten, 65807
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- Clinvest Headlands Llc
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St Louis, Missouri, Verenigde Staten, 63141
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- Sundance Clinical Research
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89109
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- Excel Clinical Research
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Las Vegas, Nevada, Verenigde Staten, 89119
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- Redbird Research
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Las Vegas, Nevada, Verenigde Staten, 89102
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- Ima Clinical Research - Las Vegas
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Las Vegas, Nevada, Verenigde Staten, 89118
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- Wake Research Las Vegas Rainbow
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Las Vegas, Nevada, Verenigde Staten, 89119
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- AMR Clinical - Las Vegas
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North Las Vegas, Nevada, Verenigde Staten, 89030
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- Las Vegas Clinical Trials
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Reno, Nevada, Verenigde Staten, 89511
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- Advanced Research Institute-Reno
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87102
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- Albuquerque Clinical Trials
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New York
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Amherst, New York, Verenigde Staten, 14226
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- Dent Neuro Institute, Buffalo
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Brooklyn, New York, Verenigde Staten, 11235
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- SPRI Clinical Trials, LLC
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Commack, New York, Verenigde Staten, 11725
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- True North Neurology
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Manlius, New York, Verenigde Staten, 13104
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- Central New York Clinical Research
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New York, New York, Verenigde Staten, 10017
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- Fieve Clinical Research, Inc
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Rochester, New York, Verenigde Staten, 14609
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- Rochester Clinical Research
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Williamsville, New York, Verenigde Staten, 14221
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- Upstate Clinical Research Associates
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28277
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- Onsite Clinical Solutions
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Greensboro, North Carolina, Verenigde Staten, 27405
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- Headache Wellness Center
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Greensboro, North Carolina, Verenigde Staten, 27405
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- Guilford Neurologic Research Partners, LLC
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Raleigh, North Carolina, Verenigde Staten, 27607
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- Eximia Research - NC, LLC
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Shelby, North Carolina, Verenigde Staten, 28150
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- Carolina Research Center, Inc
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Ohio
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Columbus, Ohio, Verenigde Staten, 43228
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- Hometown Research
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Milford, Ohio, Verenigde Staten, 45150
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- Hometown Research
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West Chester, Ohio, Verenigde Staten, 45069
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- CincyScience
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Oklahoma
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Edmond, Oklahoma, Verenigde Staten, 73034
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- OK Clinical Research, LLC
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Oklahoma City, Oklahoma, Verenigde Staten, 73102
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- Hightower Clinical
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Tulsa, Oklahoma, Verenigde Staten, 74133
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- DelRicht Research
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Yukon, Oklahoma, Verenigde Staten, 73099
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- Tekton Research, Inc.
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Oregon
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Portland, Oregon, Verenigde Staten, 97210
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- Summit Research Network
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Portland, Oregon, Verenigde Staten, 97223
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- Advanced Research Institute-Portland
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Pennsylvania
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Allentown, Pennsylvania, Verenigde Staten, 18103
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- Lehigh Center For Clinical Research
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Philadelphia, Pennsylvania, Verenigde Staten, 19114
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- Clinical Research Philadelphia
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Pittsburgh, Pennsylvania, Verenigde Staten, 15236
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- Preferred Primary Care Physicians, Inc.
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Scottdale, Pennsylvania, Verenigde Staten, 15683
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- Frontier Clinical Research, LLC
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Smithfield, Pennsylvania, Verenigde Staten, 15478
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- Frontier Clinical Research, LLC
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South Carolina
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North Charleston, South Carolina, Verenigde Staten, 29405
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- Coastal Carolina Research Center
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten, 37421
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- WR-ClinSearch, LLC
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Nashville, Tennessee, Verenigde Staten, 37203
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- Clinical Research Associates, Inc.
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Nashville, Tennessee, Verenigde Staten, 37203
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- Access Clinical Trials Inc
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Texas
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Austin, Texas, Verenigde Staten, 78731
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- FutureSearch Trials of Neurology
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Austin, Texas, Verenigde Staten, 78745
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- Tekton Research
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Cypress, Texas, Verenigde Staten, 77372
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- APD Clinical Research
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Cypress, Texas, Verenigde Staten, 77429
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- Horizon Clinical Research and Gill Neuroscience
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Dallas, Texas, Verenigde Staten, 75251
- Werving
- FutureSearch Trials of Dallas, LP
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Houston, Texas, Verenigde Staten, 77081
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- DM Clinical Research
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Houston, Texas, Verenigde Staten, 77024
- Werving
- Victorium Clinical Research
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Lampasas, Texas, Verenigde Staten, 76550
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- GMG Clinical Research, LLC dba Radiance Clinical Research
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Plano, Texas, Verenigde Staten, 75093
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- AIM Trials, LLC
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Waxahachie, Texas, Verenigde Staten, 75165
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- ClinPoint Trials
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Utah
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Bountiful, Utah, Verenigde Staten, 84010
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- Pantheon Clinical Research
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Draper, Utah, Verenigde Staten, 84020
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- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Ogden, Utah, Verenigde Staten, 84405
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- Advanced Research Institute
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Riverton, Utah, Verenigde Staten, 84096
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- Granger Medical Clinic
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Salt Lake City, Utah, Verenigde Staten, 84109
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- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Verenigde Staten, 84121
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- J. Lewis Research, Inc. / Foothill Family Clinic
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Virginia
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Newport News, Virginia, Verenigde Staten, 23606
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- Health Research of Hampton Roads, Inc. (HRHR)
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Norfolk, Virginia, Verenigde Staten, 23502
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- AMR Clinical - Norfolk
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Washington
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Seattle, Washington, Verenigde Staten, 98104
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- Seattle Clinical Research Center
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West Virginia
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Morgantown, West Virginia, Verenigde Staten, 26505
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- Frontier Clinical Research
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Wisconsin
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Kenosha, Wisconsin, Verenigde Staten, 53144
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- Clinical Investigation Specialists, Inc.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Elismetrep 10 mg
|
Oraal toegediend
Administered orally
Andere namen:
|
|
Experimenteel: Elismetrep 20 mg
|
Administered orally
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Proportion of participants with at least one treatment-emergent adverse event (TEAE)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
3 augustus 2026
Primaire voltooiing (Geschat)
1 juni 2028
Studie voltooiing (Geschat)
1 juni 2028
Studieregistratiedata
Eerst ingediend
15 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
23 juni 2026
Eerst geplaatst (Werkelijk)
29 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
26 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- K-304 P005
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .