A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
19 de agosto de 2026 atualizado por: Kallyope Inc.
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Acute Treatment of Migraine
This is a double-blind, randomized, multicenter, outpatient evaluation of the efficacy, safety, and tolerability of elismetrep, as compared with placebo, in the acute treatment of migraine.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
1800
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Annemarie Vance
- Número de telefone: 917-336-3654
- E-mail: annemarie@kallyope.com
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- Recrutamento
- Central Research Associates, LLC (CRA) dba Flourish Research
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Contato:
- Número de telefone: (205) 327-1077
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Mobile, Alabama, Estados Unidos, 36608
- Recrutamento
- AMR Mobile
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Contato:
- Número de telefone: (251) 901-2127
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Arizona
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Chandler, Arizona, Estados Unidos, 85286
- Recrutamento
- TrialSphere
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Contato:
- Número de telefone: (623) 267-8314
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Recrutamento
- Arkansas Clinical Research
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Contato:
- Número de telefone: (501) 480-5088
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California
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Colton, California, Estados Unidos, 92324
- Recrutamento
- Axiom Research, LLC
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Contato:
- Número de telefone: (909) 824-2325
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Culver City, California, Estados Unidos, 90230
- Recrutamento
- Proscience Research Group
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Contato:
- Número de telefone: (424) 227-8127
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Encino, California, Estados Unidos, 91316
- Recrutamento
- Leading Edge Research LA, LLC
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Contato:
- Número de telefone: (818) 578-4555
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Irvine, California, Estados Unidos, 92604
- Recrutamento
- Axiom Research, Orange County
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Contato:
- Número de telefone: (909) 824-2325
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Los Angeles, California, Estados Unidos, 90048
- Recrutamento
- Clinical Research Institute
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Contato:
- Número de telefone: (323) 879-9999
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Los Angeles, California, Estados Unidos, 90017
- Recrutamento
- Downtown L.A. Research Center, Inc.
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Contato:
- Número de telefone: (213) 261-3680
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Mission Viejo, California, Estados Unidos, 92691
- Recrutamento
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Contato:
- Número de telefone: (949) 752-7910
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Oceanside, California, Estados Unidos, 92056
- Recrutamento
- Excell Research
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Contato:
- Número de telefone: (760) 758-2222
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Pomona, California, Estados Unidos, 91767
- Recrutamento
- The Neurology Group
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Contato:
- Número de telefone: 603 (909) 982-2719
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Pomona, California, Estados Unidos, 91767
- Recrutamento
- Empire Clinical Research
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Contato:
- Número de telefone: (909) 981-5321
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Riverside, California, Estados Unidos, 92503
- Recrutamento
- Artemis Institute for Clinical Research
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Contato:
- Número de telefone: (855) 367-8834
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San Diego, California, Estados Unidos, 92120
- Recrutamento
- Acclaim Clinical Research
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Contato:
- Número de telefone: (855) 367-8834
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Sherman Oaks, California, Estados Unidos, 91403
- Recrutamento
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Contato:
- Número de telefone: (818) 990-2671
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Spring Valley, California, Estados Unidos, 91978
- Recrutamento
- Encompass Clinical Research
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Contato:
- Número de telefone: (619) 660-9068
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Walnut Creek, California, Estados Unidos, 94598
- Recrutamento
- Diablo Clinical Research
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Contato:
- Número de telefone: (925) 930-7267
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Walnut Creek, California, Estados Unidos, 94596
- Recrutamento
- Sunwise Clinical Research
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Contato:
- Número de telefone: (925) 298-5147
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West Covina, California, Estados Unidos, 91790
- Recrutamento
- Kinetic Clinical Research
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Contato:
- Número de telefone: (657) 230-7120
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West Hills, California, Estados Unidos, 91307
- Recrutamento
- Focus Clinical Research
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Contato:
- Número de telefone: (818) 253-8966
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Colorado
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Centennial, Colorado, Estados Unidos, 80112
- Recrutamento
- IMMUNOe Research Centers
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Contato:
- Número de telefone: (303) 771-9000
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Colorado Springs, Colorado, Estados Unidos, 80910
- Recrutamento
- MCB Clinical Research Centers
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Contato:
- Número de telefone: (719) 634-6576
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Fort Collins, Colorado, Estados Unidos, 80528
- Recrutamento
- Advanced Neurosciences Research
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Contato:
- Número de telefone: (970) 226-6111
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Connecticut
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Waterbury, Connecticut, Estados Unidos, 06708
- Recrutamento
- Chase Medical Research, LLC
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Contato:
- Número de telefone: (203) 419-4404
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Georgia
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Atlanta, Georgia, Estados Unidos, 30329
- Recrutamento
- DelRicht Research
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Contato:
- Número de telefone: (770) 417-4454
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Marietta, Georgia, Estados Unidos, 30060
- Recrutamento
- Drug Studies America
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Contato:
- Número de telefone: (678) 581-5252
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Stockbridge, Georgia, Estados Unidos, 30281
- Recrutamento
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Contato:
- Número de telefone: (770) 626-0177
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Illinois
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Chicago, Illinois, Estados Unidos, 60607
- Recrutamento
- Cedar Crosse Research Center
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Contato:
- Número de telefone: (312) 431-6780
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Chicago, Illinois, Estados Unidos, 60657
- Recrutamento
- Chicago Headache Center & Research Institute
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Contato:
- Número de telefone: (773) 935-1000
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Flossmoor, Illinois, Estados Unidos, 60477
- Recrutamento
- Healthcare Research Network II, LLC
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Contato:
- Número de telefone: (708) 388-2245
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Naperville, Illinois, Estados Unidos, 60563
- Recrutamento
- Chicago Headache Center & Research Institute
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Contato:
- Número de telefone: (415) 397-0700
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Iowa
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West Des Moines, Iowa, Estados Unidos, 50265
- Recrutamento
- Integrated Clinical Trials Solution
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Contato:
- Número de telefone: (515) 223-2300
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Kansas
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Overland Park, Kansas, Estados Unidos, 66214
- Recrutamento
- Clinical Associates Midwest, LLC
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Contato:
- Número de telefone: (913) 359-5699
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Overland Park, Kansas, Estados Unidos, 66212
- Recrutamento
- Collective Medical Research
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Contato:
- Número de telefone: (913) 381-7180
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Wichita, Kansas, Estados Unidos, 67207
- Recrutamento
- Heartland Research Associates, LLC - An AMR Company
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Contato:
- Número de telefone: (316) 689-6635
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Kentucky
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Bardstown, Kentucky, Estados Unidos, 40004
- Recrutamento
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Contato:
- Número de telefone: (502) 349-1569
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Lexington, Kentucky, Estados Unidos, 40509
- Recrutamento
- AMR Clinical - Lexington
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Contato:
- Número de telefone: (859) 264-8999
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Lexington, Kentucky, Estados Unidos, 45212
- Recrutamento
- CTI Clinical Research Center
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Contato:
- Número de telefone: (513) 721-3868
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Louisiana
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Chalmette, Louisiana, Estados Unidos, 70043
- Recrutamento
- Crescent City Headache & Neurology Center
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Contato:
- Número de telefone: (504) 418-6040
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New Orleans, Louisiana, Estados Unidos, 70115
- Recrutamento
- DelRicht Research
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Contato:
- Número de telefone: (504) 336-2667
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Maryland
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Pikesville, Maryland, Estados Unidos, 21208
- Recrutamento
- Headlands Research - Pharmasite
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Contato:
- Número de telefone: (410) 602-1440
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02131
- Recrutamento
- Boston Clinical Trials - Alcanza
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Contato:
- Número de telefone: (843) 856-3784
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Waltham, Massachusetts, Estados Unidos, 02451
- Recrutamento
- MedVadis Research Corporation, LLC
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Contato:
- Número de telefone: (781) 373-2940
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48104
- Recrutamento
- Michigan Headache Pain & Neurological Institute
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Contato:
- Número de telefone: Option 4 (734) 677-6000
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55402
- Recrutamento
- Clinical Research Institute
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Contato:
- Número de telefone: 5 (612) 333-2200
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Mississippi
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Gulfport, Mississippi, Estados Unidos, 39503
- Recrutamento
- DelRicht Research
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Contato:
- Número de telefone: (228) 588-8268
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Ridgeland, Mississippi, Estados Unidos, 39157
- Recrutamento
- Proven Endpoints
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Contato:
- Número de telefone: (601) 790-1811
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Missouri
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City of Saint Peters, Missouri, Estados Unidos, 63303
- Recrutamento
- StudyMetrix Research
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Contato:
- Número de telefone: (636) 387-5100
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Hazelwood, Missouri, Estados Unidos, 63042
- Recrutamento
- Healthcare Research Network
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Contato:
- Número de telefone: (314) 972-9600
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Kansas City, Missouri, Estados Unidos, 64114
- Recrutamento
- AMR Clinical - Kansas City
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Contato:
- Número de telefone: (816) 643-4153
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Springfield, Missouri, Estados Unidos, 65807
- Recrutamento
- Clinvest Headlands Llc
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Contato:
- Número de telefone: (417) 883-7889
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St Louis, Missouri, Estados Unidos, 63141
- Recrutamento
- Sundance Clinical Research
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Contato:
- Número de telefone: (314) 567-3377
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89109
- Recrutamento
- Excel Clinical Research
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Contato:
- Número de telefone: (702) 680-1500
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Las Vegas, Nevada, Estados Unidos, 89119
- Recrutamento
- Redbird Research
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Contato:
- Número de telefone: (702) 577-2000
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Las Vegas, Nevada, Estados Unidos, 89102
- Recrutamento
- Ima Clinical Research - Las Vegas
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Contato:
- Número de telefone: (702) 527-7401
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Las Vegas, Nevada, Estados Unidos, 89118
- Recrutamento
- Wake Research Las Vegas Rainbow
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Contato:
- Número de telefone: (702) 893-8968
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Las Vegas, Nevada, Estados Unidos, 89119
- Recrutamento
- AMR Clinical - Las Vegas
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Contato:
- Número de telefone: (702) 529-0153
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North Las Vegas, Nevada, Estados Unidos, 89030
- Recrutamento
- Las Vegas Clinical Trials
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Contato:
- Número de telefone: (702) 637-3223
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Reno, Nevada, Estados Unidos, 89511
- Recrutamento
- Advanced Research Institute - Reno
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Contato:
- Número de telefone: (775) 502-1616
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
- Recrutamento
- Albuquerque Clinical Trials
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Contato:
- Número de telefone: (505) 224-7407
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New York
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Amherst, New York, Estados Unidos, 14226
- Recrutamento
- Dent Neuro Institute, Buffalo
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Contato:
- Número de telefone: (716) 250-2017
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Brooklyn, New York, Estados Unidos, 11235
- Recrutamento
- SPRI Clinical Trials, LLC
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Contato:
- Número de telefone: (646) 747-4060
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Commack, New York, Estados Unidos, 11725
- Recrutamento
- True North Neurology
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Contato:
- Número de telefone: (631) 364-9119
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Manlius, New York, Estados Unidos, 13104
- Recrutamento
- Central New York Clinical Research
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Contato:
- Número de telefone: (315) 682-3263
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New York, New York, Estados Unidos, 10017
- Recrutamento
- Fieve Clinical Research, Inc
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Contato:
- Número de telefone: (212) 772-3570
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Rochester, New York, Estados Unidos, 14609
- Recrutamento
- Rochester Clinical Research
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Contato:
- Número de telefone: (585) 288-0890
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Williamsville, New York, Estados Unidos, 14221
- Recrutamento
- Upstate Clinical Research Associates
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Contato:
- Número de telefone: (716) 626-6320
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28277
- Recrutamento
- Onsite Clinical Solutions
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Contato:
- Número de telefone: (800) 785-3150
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Greensboro, North Carolina, Estados Unidos, 27405
- Recrutamento
- Headache Wellness Center
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Contato:
- Número de telefone: (336) 574-8000
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Greensboro, North Carolina, Estados Unidos, 27405
- Recrutamento
- Guildford Neurologic Research Partners, LLC
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Contato:
- Número de telefone: (336) 516-9103
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Raleigh, North Carolina, Estados Unidos, 27607
- Recrutamento
- Eximia Research - NC, LLC
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Contato:
- Número de telefone: (919) 800-5154
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Shelby, North Carolina, Estados Unidos, 28150
- Recrutamento
- Carolina Research Center, Inc
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Contato:
- Número de telefone: (704) 487-5228
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Ohio
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Columbus, Ohio, Estados Unidos, 43228
- Recrutamento
- Hometown Research
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Contato:
- Número de telefone: (614) 362-3980
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Milford, Ohio, Estados Unidos, 45150
- Recrutamento
- Hometown Research
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Contato:
- Número de telefone: (513) 831-5900
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West Chester, Ohio, Estados Unidos, 45069
- Recrutamento
- CincyScience
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Contato:
- Número de telefone: (513) 646-4864
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Oklahoma
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Edmond, Oklahoma, Estados Unidos, 73034
- Recrutamento
- OK Clinical Research, LLC
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Contato:
- Número de telefone: (405) 285-6811
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Oklahoma City, Oklahoma, Estados Unidos, 73102
- Recrutamento
- Hightower Clinical
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Contato:
- Número de telefone: (405) 479-8331
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Tulsa, Oklahoma, Estados Unidos, 74133
- Recrutamento
- DelRicht Research
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Contato:
- Número de telefone: (918) 932-2276
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Yukon, Oklahoma, Estados Unidos, 73099
- Recrutamento
- Tekton Research, Inc.
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Contato:
- Número de telefone: (405) 281-3433
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Oregon
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Portland, Oregon, Estados Unidos, 97210
- Recrutamento
- Summit Research Network
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Contato:
- Número de telefone: (855) 367-8834
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Portland, Oregon, Estados Unidos, 97223
- Recrutamento
- Advanced Research Institute - Portland
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Contato:
- Número de telefone: (503) 610-0033
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Pennsylvania
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Allentown, Pennsylvania, Estados Unidos, 18103
- Recrutamento
- Lehigh Center For Clinical Research
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Contato:
- Número de telefone: (818) 578-4555
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Philadelphia, Pennsylvania, Estados Unidos, 19114
- Recrutamento
- Clinical Research Philadelphia
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Contato:
- Número de telefone: (215) 676-6696
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Pittsburgh, Pennsylvania, Estados Unidos, 15236
- Recrutamento
- Preferred Primary Care Physicians, Inc.
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Contato:
- Número de telefone: (412) 650-6155
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Scottdale, Pennsylvania, Estados Unidos, 15683
- Recrutamento
- Frontier Clinical Research, LLC
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Contato:
- Número de telefone: (724) 220-5281
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Smithfield, Pennsylvania, Estados Unidos, 15478
- Recrutamento
- Frontier Clinical Research, LLC
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Contato:
- Número de telefone: (724) 569-8036
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South Carolina
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North Charleston, South Carolina, Estados Unidos, 29405
- Recrutamento
- Coastal Carolina Research Center
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Contato:
- Número de telefone: (843) 856-3784
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37421
- Recrutamento
- WR-ClinSearch, LLC
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Contato:
- Número de telefone: (423) 698-4584
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Nashville, Tennessee, Estados Unidos, 37203
- Recrutamento
- Clinical Research Associates, Inc.
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Contato:
- Número de telefone: (615) 329-0197
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Nashville, Tennessee, Estados Unidos, 37203
- Recrutamento
- Access Clinical Trials, Inc
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Contato:
- Número de telefone: (615) 320-6076
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Texas
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Austin, Texas, Estados Unidos, 78731
- Recrutamento
- FutureSearch Trials of Neurology
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Contato:
- Número de telefone: (512) 380-9925
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Austin, Texas, Estados Unidos, 78745
- Recrutamento
- Tekton Research
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Contato:
- Número de telefone: (512) 859-3834
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Cypress, Texas, Estados Unidos, 77372
- Recrutamento
- APD Clinical Research
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Contato:
- Número de telefone: (281) 315-4986
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Cypress, Texas, Estados Unidos, 77429
- Recrutamento
- Horizon Clinical Research and Gill Neuroscience
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Contato:
- Número de telefone: (949) 491-0710
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Dallas, Texas, Estados Unidos, 75251
- Recrutamento
- FutureSearch Trials of Dallas, LP
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Contato:
- Número de telefone: (214) 361-7700
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Houston, Texas, Estados Unidos, 77081
- Recrutamento
- DM Clinical Research
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Contato:
- Número de telefone: (346) 550-9559
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Houston, Texas, Estados Unidos, 77024
- Recrutamento
- Victorium Clinical Research
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Contato:
- Número de telefone: (832) 203-7026
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Lampasas, Texas, Estados Unidos, 76550
- Recrutamento
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Contato:
- Número de telefone: (512) 556-4130
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Plano, Texas, Estados Unidos, 75093
- Recrutamento
- AIM Trials, LLC
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Contato:
- Número de telefone: (214) 856-2778
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Waxahachie, Texas, Estados Unidos, 75165
- Recrutamento
- ClinPoint Trials
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Contato:
- Número de telefone: (972) 937-1640
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Utah
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Bountiful, Utah, Estados Unidos, 84010
- Recrutamento
- Pantheon Clinical Research
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Contato:
- Número de telefone: (385) 281-0550
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Draper, Utah, Estados Unidos, 84020
- Recrutamento
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Contato:
- Número de telefone: 3511 (801) 365-1032
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Ogden, Utah, Estados Unidos, 84405
- Recrutamento
- Advanced Research Institute
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Contato:
- Número de telefone: (801) 409-2040
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Riverton, Utah, Estados Unidos, 84096
- Recrutamento
- Granger Medical Clinic
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Contato:
- Número de telefone: (801) 302-1769
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Salt Lake City, Utah, Estados Unidos, 84109
- Recrutamento
- J. Lewis Research, Inc. / Foothill Family Clinic
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Contato:
- Número de telefone: 3315 (801) 486-3021
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Salt Lake City, Utah, Estados Unidos, 84121
- Recrutamento
- J. Lewis Research, Inc. / Foothill Family Clinic
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Contato:
- Número de telefone: 3538 (801) 365-1032
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Virginia
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Newport News, Virginia, Estados Unidos, 23606
- Recrutamento
- Health Research of Hampton Roads, Inc. (HRHR)
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Contato:
- Número de telefone: (757) 591-8100
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Norfolk, Virginia, Estados Unidos, 23502
- Recrutamento
- AMR Clinical - Norfolk
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Contato:
- Número de telefone: (757) 614-1001
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Recrutamento
- Seattle Clinical Research Center
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Contato:
- Número de telefone: (206) 522-3330
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West Virginia
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Morgantown, West Virginia, Estados Unidos, 26505
- Recrutamento
- Frontier Clinical Research
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Contato:
- Número de telefone: (304) 241-1648
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Wisconsin
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Kenosha, Wisconsin, Estados Unidos, 53144
- Recrutamento
- Clinical Investigation Specialists, Inc.
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Contato:
- Número de telefone: (847) 406-8080
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
1. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent. 2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements:
a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:
- A minimum of 12 months of spontaneous amenorrhea or
- A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level > 40 mIU/mL or
- At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.
Acceptable methods of birth control are:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).
- Intrauterine device (IUD);
- Intrauterine hormone-releasing system (IUS);
- Bilateral tubal occlusion;
- Vasectomized partner;
- 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).
5. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.
Exclusion Criteria:
Participants are excluded from the trial if any of the following criteria apply:
Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial.
Migraine history-related
- Has difficulty distinguishing his/her migraine attacks from tension-type headaches.
- Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.
- Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).
- Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.
- Was >50 years old at age of first migraine onset.
Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening.
Medical history related
- Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine [Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study].
- Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients 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 the past 2 months or suicidal behavior in the past 6 months.
- Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.
- Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.
- Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.
- Has a history of human immunodeficiency virus disease.
Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption or may otherwise alter the absorption of orally administered drugs (e.g. upper gastrointestinal dysmotility).
Laboratory, vital sign, and electrocardiogram related
- Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.
- Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of <30 mL/min/1.73 m2.
- Has a screening result for alanine aminotransferase or aspartate aminotransferase of >2.0 X upper limit of normal (ULN) or total bilirubin >1.5 X ULN at the Screening visit. Note: An isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range.
- Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) >450 ms for males and >470 ms for females at screening.
Has a mean value for triplicate seated systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood pressure is exclusionary on the first triplicate assessment at the Screening Visit, they may have one repeat triplicate blood pressure assessment at that visit after another rest of at least 10 minutes.
Medication use and substance abuse related
- Has known history of or suspected abuse of alcohol or recreational drugs at Screening.
- Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol [THC] or cannabidiol [CBD] within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior to screening.
Has a positive drug screen at screening. Note:
- If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the prescribing physician.
- If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatory documentation is obtained from the prescribing physician, and the stimulant medication in question is known to be detected as amphetamine on the drug screen being used.
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 study participation (detailed in the protocol). Note: Any use of the following within 8 weeks of the screening visit, or anticipated use at any point during study participation are exclusionary:
- Devices for the acute and/or preventative treatment of headache (migraine and/or other type of headache)
- Nerve blocks and/or trigger point injections for the acute and/or preventative treatment of headache (migraine and/or other type of headache).
- Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
- Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.
Has a history of non-narcotic analgesic intake ≥15 days per month for ≥3 months prior to screening.
Other
- Has known or suspected hypersensitivity to trial product(s) or related products.
- Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
- Has any surgery scheduled for the duration of the trial.
- Has a screening hemoglobin <11.0 g/dL (males) or <10.0 g/dL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia).
- Has previous participation in this trial. Participation is defined as signed informed consent.
- Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of screening or ever signed an informed consent for Study K-304 P004. Note: Patients may not be screened at more than one trial site for this study.
- Has any other disorder, 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 interpretation of efficacy and/or safety results.
- Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Placebo
|
Administrado por via oral
|
|
Experimental: Elismetrep 10 mg
|
Administered orally
Outros nomes:
|
|
Experimental: Elismetrep 20 mg
|
Administered orally
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain freedom at 2 hours post-dose
Prazo: Two hours post-dose
|
Percentage of participants that report no pain at 2 hours post-dose.
Pain will be measured on a 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
|
Two hours post-dose
|
|
Freedom from most bothersome symptoms (MBS) at 2 hours post-dose
Prazo: Two hours post-dose
|
Percentage of participants that report absence of their MBS (nausea, phonophobia, or photophobia) at 2 hours post-dose.
MBS will be measured using a binary scale (0=absent, 1=present).
|
Two hours post-dose
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain relief at 2 hours post-dose
Prazo: Two hours post-dose
|
Percentage of participants that report a pain level of moderate of severe (responses of 2 or 3 on the 4-point Likert scale) at baseline and then report a pain level of none or mild (responses of 0 or 1 on the 4-point Likert scale) at 2 hours post-dose.
|
Two hours post-dose
|
|
Sustained pain freedom from 2 to 48 hours post-dose
Prazo: From 2 to 48 hours post-dose
|
Percentage of participants that do not use any rescue medication, do not experience any headache pain through the time period of interest, and do not have missing pain data at 2, 24, or 48hours post-dose.
|
From 2 to 48 hours post-dose
|
|
Freedom from functional disability at 2 hours post-dose
Prazo: Two hours post-dose
|
Percentage of participants that self-report as being able to function normally on the functional disability scale in the subset of participants that reported any level of disability at baseline.
The scale has a 4-point numeric rating: normal (0); mildly impaired (1); moderately impaired (2); severely impaired, requires bedrest (3).
|
Two hours post-dose
|
|
Pain relief at 60 minutes post-dose
Prazo: Sixty minutes post-dose
|
Percentage of participants that report a pain level of moderate of severe (responses of 2 or 3 on the 4-point Likert scale) at baseline and then report a pain level of none or mild (responses of 0 or 1 on the 4-point Likert scale) at 60 minutes post-dose
|
Sixty minutes post-dose
|
|
Proportion requiring rescue medication within 24 hours post-dose
Prazo: Within 24 hours post-dose
|
Percentage of participants that take rescue medication within 24 hours post-dose.
|
Within 24 hours post-dose
|
|
Freedom from photophobia at 2 hours post-dose
Prazo: Two hours post-dose
|
Percentage of participants that report the absence of photophobia at 2 hours post-dose in the subset of participants that reported the presence of photophobia at baseline.
|
Two hours post-dose
|
|
Freedom from phonophobia at 2 hours post-dose
Prazo: Two hours post-dose
|
Percentage of participants that report the absence of phonophobia at 2 hours post-dose in the subset of participants that reported the presence of phonophobia at baseline.
|
Two hours post-dose
|
|
Freedom from nausea at 2 hours post-dose
Prazo: Two hours post-dose
|
Percentage of participants that report the absence of nausea at 2 hours post-dose in the subset of participants that reported the presence of nausea at baseline.
|
Two hours post-dose
|
|
Sustained pain freedom from 2 to 24 hours post-dose
Prazo: From 2 to 24 hours post-dose
|
Percentage of participants that do not use any rescue medication, do not experience any headache pain through the time period of interest, and do not have missing pain data at 2 or 24 hours post-dose.
|
From 2 to 24 hours post-dose
|
|
Sustained pain relief from 2 to 48 hours post-dose
Prazo: From 2 to 48 hours post-dose
|
Percentage of participants that do not use any rescue medications, do not experience any moderate or severe headache pain through the time period of interest, and do not have missing pain data at 2, 24, or 48 hours post-dose.
|
From 2 to 48 hours post-dose
|
|
Sustained pain relief from 2 to 24 hours post-dose
Prazo: From 2 to 24 hours post-dose
|
Percentage of participants that do not use any rescue medications, do not experience any moderate or severe headache pain through the time period of interest, and do not have missing pain data at 2 or 24 hours post-dose.
|
From 2 to 24 hours post-dose
|
|
Pain relapse from 2 to 48 hours post-dose
Prazo: From 2 to 48 hours post-dose
|
Percentage of participants that are pain free at 2 hours post-dose and have (a) mild, moderate, or severe pain (response of 1, 2, or 3 on the 4-point Likert scale) at any time point after 2 hours post-dose, or (b) missing pain data at 24 hours or 48 hours after 2 hours post-dose, or (c) intervening rescue medication use at or before 48 hours post-dose.
|
From 2 to 48 hours post-dose
|
|
Percentage of participants who experience one or more treatment-emergent adverse events (AEs)
Prazo: Up to 8 days post-dose
|
Up to 8 days post-dose
|
|
|
Percentage of participants who experience one or more treatment-emergent serious adverse events (SAEs)
Prazo: Up to 8 days post-dose
|
Up to 8 days post-dose
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de julho de 2026
Conclusão Primária (Estimado)
1 de fevereiro de 2027
Conclusão do estudo (Estimado)
1 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de junho de 2026
Primeira postagem (Real)
12 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- K-304 P003
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .