A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
19 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
1800
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Annemarie Vance
- Telefoonnummer: 917-336-3654
- E-mail: annemarie@kallyope.com
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35205
- Werving
- Central Research Associates, LLC (CRA) dba Flourish Research
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Contact:
- Telefoonnummer: (205) 327-1077
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Mobile, Alabama, Verenigde Staten, 36608
- Werving
- AMR Mobile
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Contact:
- Telefoonnummer: (251) 901-2127
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Arizona
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Chandler, Arizona, Verenigde Staten, 85286
- Werving
- TrialSphere
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Contact:
- Telefoonnummer: (623) 267-8314
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
- Werving
- Arkansas Clinical Research
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Contact:
- Telefoonnummer: (501) 480-5088
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California
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Colton, California, Verenigde Staten, 92324
- Werving
- Axiom Research, LLC
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Contact:
- Telefoonnummer: (909) 824-2325
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Culver City, California, Verenigde Staten, 90230
- Werving
- Proscience Research Group
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Contact:
- Telefoonnummer: (424) 227-8127
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Encino, California, Verenigde Staten, 91316
- Werving
- Leading Edge Research LA, LLC
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Contact:
- Telefoonnummer: (818) 578-4555
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Irvine, California, Verenigde Staten, 92604
- Werving
- Axiom Research, Orange County
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Contact:
- Telefoonnummer: (909) 824-2325
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Los Angeles, California, Verenigde Staten, 90048
- Werving
- Clinical Research Institute
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Contact:
- Telefoonnummer: (323) 879-9999
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Los Angeles, California, Verenigde Staten, 90017
- Werving
- Downtown L.A. Research Center, Inc.
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Contact:
- Telefoonnummer: (213) 261-3680
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Mission Viejo, California, Verenigde Staten, 92691
- Werving
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Contact:
- Telefoonnummer: (949) 752-7910
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Oceanside, California, Verenigde Staten, 92056
- Werving
- Excell Research
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Contact:
- Telefoonnummer: (760) 758-2222
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Pomona, California, Verenigde Staten, 91767
- Werving
- The Neurology Group
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Contact:
- Telefoonnummer: 603 (909) 982-2719
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Pomona, California, Verenigde Staten, 91767
- Werving
- Empire Clinical Research
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Contact:
- Telefoonnummer: (909) 981-5321
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Riverside, California, Verenigde Staten, 92503
- Werving
- Artemis Institute for Clinical Research
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Contact:
- Telefoonnummer: (855) 367-8834
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San Diego, California, Verenigde Staten, 92120
- Werving
- Acclaim Clinical Research
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Contact:
- Telefoonnummer: (855) 367-8834
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Sherman Oaks, California, Verenigde Staten, 91403
- Werving
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Contact:
- Telefoonnummer: (818) 990-2671
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Spring Valley, California, Verenigde Staten, 91978
- Werving
- Encompass Clinical Research
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Contact:
- Telefoonnummer: (619) 660-9068
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Walnut Creek, California, Verenigde Staten, 94598
- Werving
- Diablo Clinical Research
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Contact:
- Telefoonnummer: (925) 930-7267
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Walnut Creek, California, Verenigde Staten, 94596
- Werving
- Sunwise Clinical Research
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Contact:
- Telefoonnummer: (925) 298-5147
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West Covina, California, Verenigde Staten, 91790
- Werving
- Kinetic Clinical Research
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Contact:
- Telefoonnummer: (657) 230-7120
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West Hills, California, Verenigde Staten, 91307
- Werving
- Focus Clinical Research
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Contact:
- Telefoonnummer: (818) 253-8966
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Colorado
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Centennial, Colorado, Verenigde Staten, 80112
- Werving
- IMMUNOe Research Centers
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Contact:
- Telefoonnummer: (303) 771-9000
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Colorado Springs, Colorado, Verenigde Staten, 80910
- Werving
- MCB Clinical Research Centers
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Contact:
- Telefoonnummer: (719) 634-6576
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Fort Collins, Colorado, Verenigde Staten, 80528
- Werving
- Advanced Neurosciences Research
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Contact:
- Telefoonnummer: (970) 226-6111
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Connecticut
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Waterbury, Connecticut, Verenigde Staten, 06708
- Werving
- Chase Medical Research, LLC
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Contact:
- Telefoonnummer: (203) 419-4404
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30329
- Werving
- DelRicht Research
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Contact:
- Telefoonnummer: (770) 417-4454
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Marietta, Georgia, Verenigde Staten, 30060
- Werving
- Drug Studies America
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Contact:
- Telefoonnummer: (678) 581-5252
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Stockbridge, Georgia, Verenigde Staten, 30281
- Werving
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Contact:
- Telefoonnummer: (770) 626-0177
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Illinois
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Chicago, Illinois, Verenigde Staten, 60607
- Werving
- Cedar Crosse Research Center
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Contact:
- Telefoonnummer: (312) 431-6780
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Chicago, Illinois, Verenigde Staten, 60657
- Werving
- Chicago Headache Center & Research Institute
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Contact:
- Telefoonnummer: (773) 935-1000
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Flossmoor, Illinois, Verenigde Staten, 60477
- Werving
- Healthcare Research Network II, LLC
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Contact:
- Telefoonnummer: (708) 388-2245
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Naperville, Illinois, Verenigde Staten, 60563
- Werving
- Chicago Headache Center & Research Institute
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Contact:
- Telefoonnummer: (415) 397-0700
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Iowa
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West Des Moines, Iowa, Verenigde Staten, 50265
- Werving
- Integrated Clinical Trials Solution
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Contact:
- Telefoonnummer: (515) 223-2300
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Kansas
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Overland Park, Kansas, Verenigde Staten, 66214
- Werving
- Clinical Associates Midwest, LLC
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Contact:
- Telefoonnummer: (913) 359-5699
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Overland Park, Kansas, Verenigde Staten, 66212
- Werving
- Collective Medical Research
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Contact:
- Telefoonnummer: (913) 381-7180
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Wichita, Kansas, Verenigde Staten, 67207
- Werving
- Heartland Research Associates, LLC - An AMR Company
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Contact:
- Telefoonnummer: (316) 689-6635
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Kentucky
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Bardstown, Kentucky, Verenigde Staten, 40004
- Werving
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Contact:
- Telefoonnummer: (502) 349-1569
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Lexington, Kentucky, Verenigde Staten, 40509
- Werving
- AMR Clinical - Lexington
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Contact:
- Telefoonnummer: (859) 264-8999
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Lexington, Kentucky, Verenigde Staten, 45212
- Werving
- CTI Clinical Research Center
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Contact:
- Telefoonnummer: (513) 721-3868
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Louisiana
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Chalmette, Louisiana, Verenigde Staten, 70043
- Werving
- Crescent City Headache & Neurology Center
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Contact:
- Telefoonnummer: (504) 418-6040
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New Orleans, Louisiana, Verenigde Staten, 70115
- Werving
- DelRicht Research
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Contact:
- Telefoonnummer: (504) 336-2667
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Maryland
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Pikesville, Maryland, Verenigde Staten, 21208
- Werving
- Headlands Research - Pharmasite
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Contact:
- Telefoonnummer: (410) 602-1440
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02131
- Werving
- Boston Clinical Trials - Alcanza
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Contact:
- Telefoonnummer: (843) 856-3784
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Waltham, Massachusetts, Verenigde Staten, 02451
- Werving
- MedVadis Research Corporation, LLC
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Contact:
- Telefoonnummer: (781) 373-2940
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48104
- Werving
- Michigan Headache Pain & Neurological Institute
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Contact:
- Telefoonnummer: Option 4 (734) 677-6000
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55402
- Werving
- Clinical Research Institute
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Contact:
- Telefoonnummer: 5 (612) 333-2200
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Mississippi
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Gulfport, Mississippi, Verenigde Staten, 39503
- Werving
- DelRicht Research
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Contact:
- Telefoonnummer: (228) 588-8268
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Ridgeland, Mississippi, Verenigde Staten, 39157
- Werving
- Proven Endpoints
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Contact:
- Telefoonnummer: (601) 790-1811
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Missouri
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City of Saint Peters, Missouri, Verenigde Staten, 63303
- Werving
- StudyMetrix Research
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Contact:
- Telefoonnummer: (636) 387-5100
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Hazelwood, Missouri, Verenigde Staten, 63042
- Werving
- Healthcare Research Network
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Contact:
- Telefoonnummer: (314) 972-9600
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Kansas City, Missouri, Verenigde Staten, 64114
- Werving
- AMR Clinical - Kansas City
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Contact:
- Telefoonnummer: (816) 643-4153
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Springfield, Missouri, Verenigde Staten, 65807
- Werving
- Clinvest Headlands Llc
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Contact:
- Telefoonnummer: (417) 883-7889
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St Louis, Missouri, Verenigde Staten, 63141
- Werving
- Sundance Clinical Research
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Contact:
- Telefoonnummer: (314) 567-3377
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89109
- Werving
- Excel Clinical Research
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Contact:
- Telefoonnummer: (702) 680-1500
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Las Vegas, Nevada, Verenigde Staten, 89119
- Werving
- Redbird Research
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Contact:
- Telefoonnummer: (702) 577-2000
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Las Vegas, Nevada, Verenigde Staten, 89102
- Werving
- Ima Clinical Research - Las Vegas
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Contact:
- Telefoonnummer: (702) 527-7401
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Las Vegas, Nevada, Verenigde Staten, 89118
- Werving
- Wake Research Las Vegas Rainbow
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Contact:
- Telefoonnummer: (702) 893-8968
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Las Vegas, Nevada, Verenigde Staten, 89119
- Werving
- AMR Clinical - Las Vegas
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Contact:
- Telefoonnummer: (702) 529-0153
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North Las Vegas, Nevada, Verenigde Staten, 89030
- Werving
- Las Vegas Clinical Trials
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Contact:
- Telefoonnummer: (702) 637-3223
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Reno, Nevada, Verenigde Staten, 89511
- Werving
- Advanced Research Institute - Reno
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Contact:
- Telefoonnummer: (775) 502-1616
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87102
- Werving
- Albuquerque Clinical Trials
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Contact:
- Telefoonnummer: (505) 224-7407
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New York
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Amherst, New York, Verenigde Staten, 14226
- Werving
- Dent Neuro Institute, Buffalo
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Contact:
- Telefoonnummer: (716) 250-2017
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Brooklyn, New York, Verenigde Staten, 11235
- Werving
- SPRI Clinical Trials, LLC
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Contact:
- Telefoonnummer: (646) 747-4060
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Commack, New York, Verenigde Staten, 11725
- Werving
- True North Neurology
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Contact:
- Telefoonnummer: (631) 364-9119
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Manlius, New York, Verenigde Staten, 13104
- Werving
- Central New York Clinical Research
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Contact:
- Telefoonnummer: (315) 682-3263
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New York, New York, Verenigde Staten, 10017
- Werving
- Fieve Clinical Research, Inc
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Contact:
- Telefoonnummer: (212) 772-3570
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Rochester, New York, Verenigde Staten, 14609
- Werving
- Rochester Clinical Research
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Contact:
- Telefoonnummer: (585) 288-0890
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Williamsville, New York, Verenigde Staten, 14221
- Werving
- Upstate Clinical Research Associates
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Contact:
- Telefoonnummer: (716) 626-6320
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28277
- Werving
- Onsite Clinical Solutions
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Contact:
- Telefoonnummer: (800) 785-3150
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Greensboro, North Carolina, Verenigde Staten, 27405
- Werving
- Headache Wellness Center
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Contact:
- Telefoonnummer: (336) 574-8000
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Greensboro, North Carolina, Verenigde Staten, 27405
- Werving
- Guildford Neurologic Research Partners, LLC
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Contact:
- Telefoonnummer: (336) 516-9103
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Raleigh, North Carolina, Verenigde Staten, 27607
- Werving
- Eximia Research - NC, LLC
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Contact:
- Telefoonnummer: (919) 800-5154
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Shelby, North Carolina, Verenigde Staten, 28150
- Werving
- Carolina Research Center, Inc
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Contact:
- Telefoonnummer: (704) 487-5228
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Ohio
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Columbus, Ohio, Verenigde Staten, 43228
- Werving
- Hometown Research
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Contact:
- Telefoonnummer: (614) 362-3980
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Milford, Ohio, Verenigde Staten, 45150
- Werving
- Hometown Research
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Contact:
- Telefoonnummer: (513) 831-5900
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West Chester, Ohio, Verenigde Staten, 45069
- Werving
- CincyScience
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Contact:
- Telefoonnummer: (513) 646-4864
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Oklahoma
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Edmond, Oklahoma, Verenigde Staten, 73034
- Werving
- OK Clinical Research, LLC
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Contact:
- Telefoonnummer: (405) 285-6811
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Oklahoma City, Oklahoma, Verenigde Staten, 73102
- Werving
- Hightower Clinical
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Contact:
- Telefoonnummer: (405) 479-8331
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Tulsa, Oklahoma, Verenigde Staten, 74133
- Werving
- DelRicht Research
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Contact:
- Telefoonnummer: (918) 932-2276
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Yukon, Oklahoma, Verenigde Staten, 73099
- Werving
- Tekton Research, Inc.
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Contact:
- Telefoonnummer: (405) 281-3433
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Oregon
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Portland, Oregon, Verenigde Staten, 97210
- Werving
- Summit Research Network
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Contact:
- Telefoonnummer: (855) 367-8834
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Portland, Oregon, Verenigde Staten, 97223
- Werving
- Advanced Research Institute - Portland
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Contact:
- Telefoonnummer: (503) 610-0033
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Pennsylvania
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Allentown, Pennsylvania, Verenigde Staten, 18103
- Werving
- Lehigh Center For Clinical Research
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Contact:
- Telefoonnummer: (818) 578-4555
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Philadelphia, Pennsylvania, Verenigde Staten, 19114
- Werving
- Clinical Research Philadelphia
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Contact:
- Telefoonnummer: (215) 676-6696
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Pittsburgh, Pennsylvania, Verenigde Staten, 15236
- Werving
- Preferred Primary Care Physicians, Inc.
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Contact:
- Telefoonnummer: (412) 650-6155
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Scottdale, Pennsylvania, Verenigde Staten, 15683
- Werving
- Frontier Clinical Research, LLC
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Contact:
- Telefoonnummer: (724) 220-5281
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Smithfield, Pennsylvania, Verenigde Staten, 15478
- Werving
- Frontier Clinical Research, LLC
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Contact:
- Telefoonnummer: (724) 569-8036
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South Carolina
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North Charleston, South Carolina, Verenigde Staten, 29405
- Werving
- Coastal Carolina Research Center
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Contact:
- Telefoonnummer: (843) 856-3784
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten, 37421
- Werving
- WR-ClinSearch, LLC
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Contact:
- Telefoonnummer: (423) 698-4584
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Nashville, Tennessee, Verenigde Staten, 37203
- Werving
- Clinical Research Associates, Inc.
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Contact:
- Telefoonnummer: (615) 329-0197
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Nashville, Tennessee, Verenigde Staten, 37203
- Werving
- Access Clinical Trials, Inc
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Contact:
- Telefoonnummer: (615) 320-6076
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Texas
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Austin, Texas, Verenigde Staten, 78731
- Werving
- FutureSearch Trials of Neurology
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Contact:
- Telefoonnummer: (512) 380-9925
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Austin, Texas, Verenigde Staten, 78745
- Werving
- Tekton Research
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Contact:
- Telefoonnummer: (512) 859-3834
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Cypress, Texas, Verenigde Staten, 77372
- Werving
- APD Clinical Research
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Contact:
- Telefoonnummer: (281) 315-4986
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Cypress, Texas, Verenigde Staten, 77429
- Werving
- Horizon Clinical Research and Gill Neuroscience
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Contact:
- Telefoonnummer: (949) 491-0710
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Dallas, Texas, Verenigde Staten, 75251
- Werving
- FutureSearch Trials of Dallas, LP
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Contact:
- Telefoonnummer: (214) 361-7700
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Houston, Texas, Verenigde Staten, 77081
- Werving
- DM Clinical Research
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Contact:
- Telefoonnummer: (346) 550-9559
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Houston, Texas, Verenigde Staten, 77024
- Werving
- Victorium Clinical Research
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Contact:
- Telefoonnummer: (832) 203-7026
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Lampasas, Texas, Verenigde Staten, 76550
- Werving
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Contact:
- Telefoonnummer: (512) 556-4130
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Plano, Texas, Verenigde Staten, 75093
- Werving
- AIM Trials, LLC
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Contact:
- Telefoonnummer: (214) 856-2778
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Waxahachie, Texas, Verenigde Staten, 75165
- Werving
- ClinPoint Trials
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Contact:
- Telefoonnummer: (972) 937-1640
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Utah
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Bountiful, Utah, Verenigde Staten, 84010
- Werving
- Pantheon Clinical Research
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Contact:
- Telefoonnummer: (385) 281-0550
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Draper, Utah, Verenigde Staten, 84020
- Werving
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Contact:
- Telefoonnummer: 3511 (801) 365-1032
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Ogden, Utah, Verenigde Staten, 84405
- Werving
- Advanced Research Institute
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Contact:
- Telefoonnummer: (801) 409-2040
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Riverton, Utah, Verenigde Staten, 84096
- Werving
- Granger Medical Clinic
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Contact:
- Telefoonnummer: (801) 302-1769
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Salt Lake City, Utah, Verenigde Staten, 84109
- Werving
- J. Lewis Research, Inc. / Foothill Family Clinic
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Contact:
- Telefoonnummer: 3315 (801) 486-3021
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Salt Lake City, Utah, Verenigde Staten, 84121
- Werving
- J. Lewis Research, Inc. / Foothill Family Clinic
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Contact:
- Telefoonnummer: 3538 (801) 365-1032
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Virginia
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Newport News, Virginia, Verenigde Staten, 23606
- Werving
- Health Research of Hampton Roads, Inc. (HRHR)
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Contact:
- Telefoonnummer: (757) 591-8100
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Norfolk, Virginia, Verenigde Staten, 23502
- Werving
- AMR Clinical - Norfolk
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Contact:
- Telefoonnummer: (757) 614-1001
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Washington
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Seattle, Washington, Verenigde Staten, 98104
- Werving
- Seattle Clinical Research Center
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Contact:
- Telefoonnummer: (206) 522-3330
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West Virginia
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Morgantown, West Virginia, Verenigde Staten, 26505
- Werving
- Frontier Clinical Research
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Contact:
- Telefoonnummer: (304) 241-1648
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Wisconsin
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Kenosha, Wisconsin, Verenigde Staten, 53144
- Werving
- Clinical Investigation Specialists, Inc.
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Contact:
- Telefoonnummer: (847) 406-8080
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Placebo
|
Oraal toegediend
|
|
Experimenteel: Elismetrep 10 mg
|
Administered orally
Andere namen:
|
|
Experimenteel: Elismetrep 20 mg
|
Administered orally
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain freedom at 2 hours post-dose
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain relief at 2 hours post-dose
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Up to 8 days post-dose
|
Up to 8 days post-dose
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juli 2026
Primaire voltooiing (Geschat)
1 februari 2027
Studie voltooiing (Geschat)
1 februari 2027
Studieregistratiedata
Eerst ingediend
9 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juni 2026
Eerst geplaatst (Werkelijk)
12 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
19 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- K-304 P003
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .