A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
9 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
1800
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Annemarie Vance
- Numero di telefono: 917-336-3654
- Email: annemarie@kallyope.com
Luoghi di studio
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San Juan, Porto Rico, 00907
- Solace Clinical Research
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Contatto:
- Numero di telefono: (787) 425-4881
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Alabama
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Birmingham, Alabama, Stati Uniti, 35205
- Central Research Associates, LLC (CRA) dba Flourish Research
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Contatto:
- Numero di telefono: (205) 327-1077
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Mobile, Alabama, Stati Uniti, 36608
- AMR Mobile
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Contatto:
- Numero di telefono: (251) 901-2127
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Arizona
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Chandler, Arizona, Stati Uniti, 85286
- TrialSphere
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Contatto:
- Numero di telefono: (623) 267-8314
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- Arkansas Clinical Research
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Contatto:
- Numero di telefono: (501) 480-5088
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California
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Colton, California, Stati Uniti, 92324
- Axiom Research, LLC
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Contatto:
- Numero di telefono: (909) 824-2325
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Culver City, California, Stati Uniti, 90230
- ProScience Research Group
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Contatto:
- Numero di telefono: (424) 227-8127
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Encino, California, Stati Uniti, 91316
- Leading Edge Research LA, LLC
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Contatto:
- Numero di telefono: (818) 578-4555
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Irvine, California, Stati Uniti, 92604
- Axiom Research, Orange County
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Contatto:
- Numero di telefono: (909) 824-2325
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Los Angeles, California, Stati Uniti, 90048
- Clinical Research Institute
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Contatto:
- Numero di telefono: (323) 879-9999
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Los Angeles, California, Stati Uniti, 90017
- Downtown L.A. Research Center, Inc.
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Contatto:
- Numero di telefono: (213) 261-3680
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Mission Viejo, California, Stati Uniti, 92691
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Contatto:
- Numero di telefono: (949) 752-7910
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Oceanside, California, Stati Uniti, 92056
- Excell Research
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Contatto:
- Numero di telefono: (760) 758-2222
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Pomona, California, Stati Uniti, 91767
- The Neurology Group
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Contatto:
- Numero di telefono: 603 (909) 982-2719
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Pomona, California, Stati Uniti, 91767
- Empire Clinical Research
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Contatto:
- Numero di telefono: (909) 981-5321
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Riverside, California, Stati Uniti, 92503
- Artemis Institute for Clinical Research
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Contatto:
- Numero di telefono: (855) 367-8834
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San Diego, California, Stati Uniti, 92120
- Acclaim Clinical Research
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Contatto:
- Numero di telefono: (855) 367-8834
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Sherman Oaks, California, Stati Uniti, 91403
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Contatto:
- Numero di telefono: (818) 990-2671
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Spring Valley, California, Stati Uniti, 91978
- Encompass Clinical Research
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Contatto:
- Numero di telefono: (619) 660-9068
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Walnut Creek, California, Stati Uniti, 94598
- Diablo Clinical Research
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Contatto:
- Numero di telefono: (925) 930-7267
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Walnut Creek, California, Stati Uniti, 94596
- Sunwise Clinical Research
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Contatto:
- Numero di telefono: (925) 298-5147
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West Covina, California, Stati Uniti, 91790
- Kinetic Clinical Research
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Contatto:
- Numero di telefono: (657) 230-7120
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West Hills, California, Stati Uniti, 91307
- Focus Clinical Research
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Contatto:
- Numero di telefono: (818) 253-8966
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Colorado
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Centennial, Colorado, Stati Uniti, 80112
- IMMUNOe Research Centers
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Contatto:
- Numero di telefono: (303) 771-9000
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Colorado Springs, Colorado, Stati Uniti, 80910
- MCB Clinical Research Centers
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Contatto:
- Numero di telefono: (719) 634-6576
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Fort Collins, Colorado, Stati Uniti, 80528
- Advanced Neurosciences Research
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Contatto:
- Numero di telefono: (970) 226-6111
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Connecticut
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Waterbury, Connecticut, Stati Uniti, 06708
- Chase Medical Research, LLC
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Contatto:
- Numero di telefono: (203) 419-4404
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Georgia
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Atlanta, Georgia, Stati Uniti, 30329
- DelRicht Research
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Contatto:
- Numero di telefono: (770) 417-4454
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Marietta, Georgia, Stati Uniti, 30060
- Drug Studies America
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Contatto:
- Numero di telefono: (678) 581-5252
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Stockbridge, Georgia, Stati Uniti, 30281
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Contatto:
- Numero di telefono: (770) 626-0177
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Illinois
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Chicago, Illinois, Stati Uniti, 60607
- Cedar Crosse Research Center
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Contatto:
- Numero di telefono: (312) 431-6780
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Chicago, Illinois, Stati Uniti, 60657
- Chicago Headache Center & Research Institute
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Contatto:
- Numero di telefono: (773) 935-1000
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Flossmoor, Illinois, Stati Uniti, 60477
- Healthcare Research Network II, LLC
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Contatto:
- Numero di telefono: (708) 388-2245
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Naperville, Illinois, Stati Uniti, 60563
- Chicago Headache Center & Research Institute
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Contatto:
- Numero di telefono: (415) 397-0700
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Iowa
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West Des Moines, Iowa, Stati Uniti, 50265
- Integrated Clinical Trials Solution
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Contatto:
- Numero di telefono: (515) 223-2300
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Kansas
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Overland Park, Kansas, Stati Uniti, 66212
- Collective Medical Research
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Contatto:
- Numero di telefono: (913) 381-7180
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Overland Park, Kansas, Stati Uniti, 66214
- Clinical Associates Midwest, LLC
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Contatto:
- Numero di telefono: (913) 359-5699
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Wichita, Kansas, Stati Uniti, 67207
- Heartland Research Associates, LLC - An AMR Company
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Contatto:
- Numero di telefono: (316) 689-6635
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Kentucky
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Bardstown, Kentucky, Stati Uniti, 40004
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Contatto:
- Numero di telefono: (502) 349-1569
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Lexington, Kentucky, Stati Uniti, 40509
- AMR Clinical - Lexington
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Contatto:
- Numero di telefono: (859) 264-8999
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Lexington, Kentucky, Stati Uniti, 45212
- CTI Clinical Research Center
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Contatto:
- Numero di telefono: (513) 721-3868
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Louisville, Kentucky, Stati Uniti, 40213
- Monroe Biomedical Research (former L-MARC Research Center)
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Contatto:
- Numero di telefono: (502) 305-1010
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Louisiana
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Chalmette, Louisiana, Stati Uniti, 70043
- Crescent City Headache & Neurology Center
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Contatto:
- Numero di telefono: (504) 418-6040
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New Orleans, Louisiana, Stati Uniti, 70115
- DelRicht Research
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Contatto:
- Numero di telefono: (504) 336-2667
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Maryland
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Pikesville, Maryland, Stati Uniti, 21208
- Headlands Research - Pharmasite
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Contatto:
- Numero di telefono: (410) 602-1440
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02131
- Boston Clinical Trials - Alcanza
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Contatto:
- Numero di telefono: (843) 856-3784
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Waltham, Massachusetts, Stati Uniti, 02451
- MedVadis Research Corporation, LLC
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Contatto:
- Numero di telefono: (781) 373-2940
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48104
- Michigan Headache Pain & Neurological Institute
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Contatto:
- Numero di telefono: Option 4 (734) 677-6000
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Minnesota
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Burnsville, Minnesota, Stati Uniti, 55337
- Minneapolis Clinic of Neurology
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Contatto:
- Numero di telefono: (763) 302-4162
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Minneapolis, Minnesota, Stati Uniti, 55402
- Clinical Research Institute
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Contatto:
- Numero di telefono: 5 (612) 333-2200
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Mississippi
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Gulfport, Mississippi, Stati Uniti, 39503
- DelRicht Research
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Contatto:
- Numero di telefono: (228) 588-8268
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Ridgeland, Mississippi, Stati Uniti, 39157
- Proven Endpoints
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Contatto:
- Numero di telefono: (601) 790-1811
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Missouri
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City of Saint Peters, Missouri, Stati Uniti, 63303
- StudyMetrix Research
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Contatto:
- Numero di telefono: (636) 387-5100
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Hazelwood, Missouri, Stati Uniti, 63042
- Healthcare Research Network
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Contatto:
- Numero di telefono: (314) 972-9600
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Kansas City, Missouri, Stati Uniti, 64114
- AMR Clinical - Kansas City
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Contatto:
- Numero di telefono: (816) 643-4153
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Springfield, Missouri, Stati Uniti, 65807
- Clinvest Headlands LLC
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Contatto:
- Numero di telefono: (417) 883-7889
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St Louis, Missouri, Stati Uniti, 63141
- Sundance Clinical Research
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Contatto:
- Numero di telefono: (314) 567-3377
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89109
- Excel Clinical Research
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Contatto:
- Numero di telefono: (702) 680-1500
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Las Vegas, Nevada, Stati Uniti, 89119
- Redbird Research
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Contatto:
- Numero di telefono: (702) 577-2000
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Las Vegas, Nevada, Stati Uniti, 89102
- IMA Clinical Research - Las Vegas
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Contatto:
- Numero di telefono: (702) 527-7401
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Las Vegas, Nevada, Stati Uniti, 89119
- AMR Clinical - Las Vegas
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Contatto:
- Numero di telefono: (702) 529-0153
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Las Vegas, Nevada, Stati Uniti, 89118
- Wake Research Las Vegas Rainbow
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Contatto:
- Numero di telefono: (702) 893-8968
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North Las Vegas, Nevada, Stati Uniti, 89030
- Las Vegas Clinical Trials
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Contatto:
- Numero di telefono: (702) 637-3223
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Reno, Nevada, Stati Uniti, 89511
- Advanced Research Institute - Reno
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Contatto:
- Numero di telefono: (775) 502-1616
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
- Albuquerque Clinical Trials
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Contatto:
- Numero di telefono: (505) 224-7407
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New York
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Amherst, New York, Stati Uniti, 14226
- Dent Neuro Institute, Buffalo
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Contatto:
- Numero di telefono: (716) 250-2017
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Brooklyn, New York, Stati Uniti, 11235
- SPRI Clinical Trials, LLC
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Contatto:
- Numero di telefono: (646) 747-4060
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Commack, New York, Stati Uniti, 11725
- True North Neurology
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Contatto:
- Numero di telefono: (631) 364-9119
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Manlius, New York, Stati Uniti, 13104
- Central New York Clinical Research
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Contatto:
- Numero di telefono: (315) 682-3263
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New York, New York, Stati Uniti, 10017
- Fieve Clinical Research, Inc
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Contatto:
- Numero di telefono: (212) 772-3570
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Rochester, New York, Stati Uniti, 14609
- Rochester Clinical Research
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Contatto:
- Numero di telefono: (585) 288-0890
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Williamsville, New York, Stati Uniti, 14221
- Upstate Clinical Research Associates
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Contatto:
- Numero di telefono: (716) 626-6320
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28277
- OnSite Clinical Solutions
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Contatto:
- Numero di telefono: (800) 785-3150
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Greensboro, North Carolina, Stati Uniti, 27405
- Headache Wellness Center
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Contatto:
- Numero di telefono: (336) 574-8000
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Greensboro, North Carolina, Stati Uniti, 27405
- Guildford Neurologic Research Partners, LLC
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Contatto:
- Numero di telefono: (336) 516-9103
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Raleigh, North Carolina, Stati Uniti, 27607
- Eximia Research - NC, LLC
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Contatto:
- Numero di telefono: (919) 800-5154
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Shelby, North Carolina, Stati Uniti, 28150
- Carolina Research Center, Inc
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Contatto:
- Numero di telefono: (704) 487-5228
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Ohio
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Columbus, Ohio, Stati Uniti, 43228
- Hometown Research
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Contatto:
- Numero di telefono: (614) 362-3980
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Huber Heights, Ohio, Stati Uniti, 45424
- Hometown Research
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Contatto:
- Numero di telefono: (937) 912-4364
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Milford, Ohio, Stati Uniti, 45150
- Hometown Research
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Contatto:
- Numero di telefono: (513) 831-5900
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West Chester, Ohio, Stati Uniti, 45069
- CincyScience
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Contatto:
- Numero di telefono: (513) 646-4864
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Oklahoma
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Edmond, Oklahoma, Stati Uniti, 73034
- OK Clinical Research, LLC
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Contatto:
- Numero di telefono: (405) 285-6811
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Oklahoma City, Oklahoma, Stati Uniti, 73102
- Hightower Clinical
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Contatto:
- Numero di telefono: (405) 479-8331
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Tulsa, Oklahoma, Stati Uniti, 74133
- DelRicht Research
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Contatto:
- Numero di telefono: (918) 932-2276
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Yukon, Oklahoma, Stati Uniti, 73099
- Tekton Research, Inc.
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Contatto:
- Numero di telefono: (405) 281-3433
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Oregon
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Portland, Oregon, Stati Uniti, 97210
- Summit Research Network
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Contatto:
- Numero di telefono: (855) 367-8834
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Portland, Oregon, Stati Uniti, 97223
- Advanced Research Institute - Portland
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Contatto:
- Numero di telefono: (503) 610-0033
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Pennsylvania
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Allentown, Pennsylvania, Stati Uniti, 18103
- Lehigh Center for Clinical Research
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Contatto:
- Numero di telefono: (818) 578-4555
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Philadelphia, Pennsylvania, Stati Uniti, 19114
- Clinical Research Philadelphia
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Contatto:
- Numero di telefono: (215) 676-6696
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Pittsburgh, Pennsylvania, Stati Uniti, 15236
- Preferred Primary Care Physicians, Inc.
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Contatto:
- Numero di telefono: (412) 650-6155
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Scottdale, Pennsylvania, Stati Uniti, 15683
- Frontier Clinical Research, LLC
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Contatto:
- Numero di telefono: (724) 220-5281
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Smithfield, Pennsylvania, Stati Uniti, 15478
- Frontier Clinical Research, LLC
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Contatto:
- Numero di telefono: (724) 569-8036
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South Carolina
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North Charleston, South Carolina, Stati Uniti, 29405
- Coastal Carolina Research Center
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Contatto:
- Numero di telefono: (843) 856-3784
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37421
- WR-ClinSearch, LLC
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Contatto:
- Numero di telefono: (423) 698-4584
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Nashville, Tennessee, Stati Uniti, 37203
- Access Clinical Trials, Inc
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Contatto:
- Numero di telefono: (615) 320-6076
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Nashville, Tennessee, Stati Uniti, 37203
- Clinical Research Associates, Inc.
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Contatto:
- Numero di telefono: (615) 329-0197
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Texas
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Austin, Texas, Stati Uniti, 78731
- FutureSearch Trials of Neurology
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Contatto:
- Numero di telefono: (512) 380-9925
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Austin, Texas, Stati Uniti, 78745
- Tekton Research
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Contatto:
- Numero di telefono: (512) 859-3834
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Cypress, Texas, Stati Uniti, 77372
- APD Clinical Research
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Contatto:
- Numero di telefono: (281) 315-4986
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Cypress, Texas, Stati Uniti, 77429
- Horizon Clinical Research and Gill Neuroscience
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Contatto:
- Numero di telefono: (949) 491-0710
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Dallas, Texas, Stati Uniti, 75243
- Relaro Medical Trials, LLC
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Contatto:
- Numero di telefono: (469) 730-3282
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Dallas, Texas, Stati Uniti, 75251
- FutureSearch Trials of Dallas, LP
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Contatto:
- Numero di telefono: (214) 361-7700
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Fort Worth, Texas, Stati Uniti, 76104
- Helios CR, Inc. - Fort Worth
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Contatto:
- Numero di telefono: (817) 348-0228
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Houston, Texas, Stati Uniti, 77024
- Victorium Clinical Research
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Contatto:
- Numero di telefono: (832) 203-7026
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Houston, Texas, Stati Uniti, 77081
- DM Clinical Research
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Contatto:
- Numero di telefono: (346) 550-9559
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Keller, Texas, Stati Uniti, 76248
- Helios CR, Inc. - Keller
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Contatto:
- Numero di telefono: (682) 774-8013
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Lampasas, Texas, Stati Uniti, 76550
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Contatto:
- Numero di telefono: (512) 556-4130
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Plano, Texas, Stati Uniti, 75093
- Aim Trials, LLC
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Contatto:
- Numero di telefono: (214) 856-2778
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Waxahachie, Texas, Stati Uniti, 75165
- Clinpoint Trials
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Contatto:
- Numero di telefono: (972) 937-1640
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Utah
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Bountiful, Utah, Stati Uniti, 84010
- Pantheon Clinical Research
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Contatto:
- Numero di telefono: (385) 281-0550
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Draper, Utah, Stati Uniti, 84020
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Contatto:
- Numero di telefono: 3511 (801) 365-1032
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Ogden, Utah, Stati Uniti, 84405
- Advanced Research Institute
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Contatto:
- Numero di telefono: (801) 409-2040
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Riverton, Utah, Stati Uniti, 84096
- Granger Medical Clinic
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Contatto:
- Numero di telefono: (801) 302-1769
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Salt Lake City, Utah, Stati Uniti, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Contatto:
- Numero di telefono: 3315 (801) 486-3021
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Salt Lake City, Utah, Stati Uniti, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic
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Contatto:
- Numero di telefono: 3538 (801) 365-1032
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Virginia
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Newport News, Virginia, Stati Uniti, 23606
- Health Research of Hampton Roads, Inc. (HRHR)
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Contatto:
- Numero di telefono: (757) 591-8100
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Norfolk, Virginia, Stati Uniti, 23502
- AMR Clinical - Norfolk
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Contatto:
- Numero di telefono: (757) 614-1001
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Washington
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Seattle, Washington, Stati Uniti, 98104
- Seattle Clinical Research Center
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Contatto:
- Numero di telefono: (206) 522-3330
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West Virginia
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Morgantown, West Virginia, Stati Uniti, 26505
- Frontier Clinical Research
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Contatto:
- Numero di telefono: (304) 241-1648
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Wisconsin
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Kenosha, Wisconsin, Stati Uniti, 53144
- Clinical Investigation Specialists, Inc.
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Contatto:
- Numero di telefono: (847) 406-8080
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
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.
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 (not already specified in other criteria) or is anticipated to violate these requirements during study participation (detailed in the protocol).
- 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Placebo
|
Somministrato per via orale
|
|
Sperimentale: Elismetrep 10 mg
|
Administered orally
Altri nomi:
|
|
Sperimentale: Elismetrep 20 mg
|
Administered orally
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain freedom at 2 hours post-dose
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain relief at 2 hours post-dose
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Up to 8 days post-dose
|
Up to 8 days post-dose
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
1 febbraio 2027
Completamento dello studio (Stimato)
1 febbraio 2027
Date di iscrizione allo studio
Primo inviato
9 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
9 giugno 2026
Primo Inserito (Effettivo)
12 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- K-304 P003
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .