A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
19. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
1800
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Annemarie Vance
- Telefonnummer: 917-336-3654
- E-post: annemarie@kallyope.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35205
- Rekruttering
- Central Research Associates, LLC (CRA) dba Flourish Research
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Ta kontakt med:
- Telefonnummer: (205) 327-1077
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Mobile, Alabama, Forente stater, 36608
- Rekruttering
- AMR Mobile
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Ta kontakt med:
- Telefonnummer: (251) 901-2127
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Arizona
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Chandler, Arizona, Forente stater, 85286
- Rekruttering
- TrialSphere
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Ta kontakt med:
- Telefonnummer: (623) 267-8314
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- Rekruttering
- Arkansas Clinical Research
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Ta kontakt med:
- Telefonnummer: (501) 480-5088
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California
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Colton, California, Forente stater, 92324
- Rekruttering
- Axiom Research, LLC
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Ta kontakt med:
- Telefonnummer: (909) 824-2325
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Culver City, California, Forente stater, 90230
- Rekruttering
- Proscience Research Group
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Ta kontakt med:
- Telefonnummer: (424) 227-8127
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Encino, California, Forente stater, 91316
- Rekruttering
- Leading Edge Research LA, LLC
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Ta kontakt med:
- Telefonnummer: (818) 578-4555
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Irvine, California, Forente stater, 92604
- Rekruttering
- Axiom Research, Orange County
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Ta kontakt med:
- Telefonnummer: (909) 824-2325
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Los Angeles, California, Forente stater, 90048
- Rekruttering
- Clinical Research Institute
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Ta kontakt med:
- Telefonnummer: (323) 879-9999
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Los Angeles, California, Forente stater, 90017
- Rekruttering
- Downtown L.A. Research Center, Inc.
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Ta kontakt med:
- Telefonnummer: (213) 261-3680
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Mission Viejo, California, Forente stater, 92691
- Rekruttering
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Ta kontakt med:
- Telefonnummer: (949) 752-7910
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Oceanside, California, Forente stater, 92056
- Rekruttering
- Excell Research
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Ta kontakt med:
- Telefonnummer: (760) 758-2222
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Pomona, California, Forente stater, 91767
- Rekruttering
- The Neurology Group
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Ta kontakt med:
- Telefonnummer: 603 (909) 982-2719
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Pomona, California, Forente stater, 91767
- Rekruttering
- Empire Clinical Research
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Ta kontakt med:
- Telefonnummer: (909) 981-5321
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Riverside, California, Forente stater, 92503
- Rekruttering
- Artemis Institute for Clinical Research
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Ta kontakt med:
- Telefonnummer: (855) 367-8834
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San Diego, California, Forente stater, 92120
- Rekruttering
- Acclaim Clinical Research
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Ta kontakt med:
- Telefonnummer: (855) 367-8834
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Sherman Oaks, California, Forente stater, 91403
- Rekruttering
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Ta kontakt med:
- Telefonnummer: (818) 990-2671
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Spring Valley, California, Forente stater, 91978
- Rekruttering
- Encompass Clinical Research
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Ta kontakt med:
- Telefonnummer: (619) 660-9068
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Walnut Creek, California, Forente stater, 94598
- Rekruttering
- Diablo Clinical Research
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Ta kontakt med:
- Telefonnummer: (925) 930-7267
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Walnut Creek, California, Forente stater, 94596
- Rekruttering
- Sunwise Clinical Research
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Ta kontakt med:
- Telefonnummer: (925) 298-5147
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West Covina, California, Forente stater, 91790
- Rekruttering
- Kinetic Clinical Research
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Ta kontakt med:
- Telefonnummer: (657) 230-7120
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West Hills, California, Forente stater, 91307
- Rekruttering
- Focus Clinical Research
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Ta kontakt med:
- Telefonnummer: (818) 253-8966
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Colorado
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Centennial, Colorado, Forente stater, 80112
- Rekruttering
- IMMUNOe Research Centers
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Ta kontakt med:
- Telefonnummer: (303) 771-9000
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Colorado Springs, Colorado, Forente stater, 80910
- Rekruttering
- MCB Clinical Research Centers
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Ta kontakt med:
- Telefonnummer: (719) 634-6576
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Fort Collins, Colorado, Forente stater, 80528
- Rekruttering
- Advanced Neurosciences Research
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Ta kontakt med:
- Telefonnummer: (970) 226-6111
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Connecticut
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Waterbury, Connecticut, Forente stater, 06708
- Rekruttering
- Chase Medical Research, LLC
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Ta kontakt med:
- Telefonnummer: (203) 419-4404
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Georgia
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Atlanta, Georgia, Forente stater, 30329
- Rekruttering
- DelRicht Research
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Ta kontakt med:
- Telefonnummer: (770) 417-4454
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Marietta, Georgia, Forente stater, 30060
- Rekruttering
- Drug Studies America
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Ta kontakt med:
- Telefonnummer: (678) 581-5252
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Stockbridge, Georgia, Forente stater, 30281
- Rekruttering
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Ta kontakt med:
- Telefonnummer: (770) 626-0177
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Illinois
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Chicago, Illinois, Forente stater, 60607
- Rekruttering
- Cedar Crosse Research Center
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Ta kontakt med:
- Telefonnummer: (312) 431-6780
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Chicago, Illinois, Forente stater, 60657
- Rekruttering
- Chicago Headache Center & Research Institute
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Ta kontakt med:
- Telefonnummer: (773) 935-1000
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Flossmoor, Illinois, Forente stater, 60477
- Rekruttering
- Healthcare Research Network II, LLC
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Ta kontakt med:
- Telefonnummer: (708) 388-2245
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Naperville, Illinois, Forente stater, 60563
- Rekruttering
- Chicago Headache Center & Research Institute
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Ta kontakt med:
- Telefonnummer: (415) 397-0700
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Iowa
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West Des Moines, Iowa, Forente stater, 50265
- Rekruttering
- Integrated Clinical Trials Solution
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Ta kontakt med:
- Telefonnummer: (515) 223-2300
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Kansas
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Overland Park, Kansas, Forente stater, 66214
- Rekruttering
- Clinical Associates Midwest, LLC
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Ta kontakt med:
- Telefonnummer: (913) 359-5699
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Overland Park, Kansas, Forente stater, 66212
- Rekruttering
- Collective Medical Research
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Ta kontakt med:
- Telefonnummer: (913) 381-7180
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Wichita, Kansas, Forente stater, 67207
- Rekruttering
- Heartland Research Associates, LLC - An AMR Company
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Ta kontakt med:
- Telefonnummer: (316) 689-6635
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Kentucky
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Bardstown, Kentucky, Forente stater, 40004
- Rekruttering
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Ta kontakt med:
- Telefonnummer: (502) 349-1569
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Lexington, Kentucky, Forente stater, 40509
- Rekruttering
- AMR Clinical - Lexington
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Ta kontakt med:
- Telefonnummer: (859) 264-8999
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Lexington, Kentucky, Forente stater, 45212
- Rekruttering
- CTI Clinical Research Center
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Ta kontakt med:
- Telefonnummer: (513) 721-3868
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Louisiana
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Chalmette, Louisiana, Forente stater, 70043
- Rekruttering
- Crescent City Headache & Neurology Center
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Ta kontakt med:
- Telefonnummer: (504) 418-6040
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New Orleans, Louisiana, Forente stater, 70115
- Rekruttering
- DelRicht Research
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Ta kontakt med:
- Telefonnummer: (504) 336-2667
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Maryland
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Pikesville, Maryland, Forente stater, 21208
- Rekruttering
- Headlands Research - Pharmasite
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Ta kontakt med:
- Telefonnummer: (410) 602-1440
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Massachusetts
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Boston, Massachusetts, Forente stater, 02131
- Rekruttering
- Boston Clinical Trials - Alcanza
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Ta kontakt med:
- Telefonnummer: (843) 856-3784
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Waltham, Massachusetts, Forente stater, 02451
- Rekruttering
- MedVadis Research Corporation, LLC
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Ta kontakt med:
- Telefonnummer: (781) 373-2940
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Michigan
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Ann Arbor, Michigan, Forente stater, 48104
- Rekruttering
- Michigan Headache Pain & Neurological Institute
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Ta kontakt med:
- Telefonnummer: Option 4 (734) 677-6000
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55402
- Rekruttering
- Clinical Research Institute
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Ta kontakt med:
- Telefonnummer: 5 (612) 333-2200
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Mississippi
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Gulfport, Mississippi, Forente stater, 39503
- Rekruttering
- DelRicht Research
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Ta kontakt med:
- Telefonnummer: (228) 588-8268
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Ridgeland, Mississippi, Forente stater, 39157
- Rekruttering
- Proven Endpoints
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Ta kontakt med:
- Telefonnummer: (601) 790-1811
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Missouri
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City of Saint Peters, Missouri, Forente stater, 63303
- Rekruttering
- StudyMetrix Research
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Ta kontakt med:
- Telefonnummer: (636) 387-5100
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Hazelwood, Missouri, Forente stater, 63042
- Rekruttering
- Healthcare Research Network
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Ta kontakt med:
- Telefonnummer: (314) 972-9600
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Kansas City, Missouri, Forente stater, 64114
- Rekruttering
- AMR Clinical - Kansas City
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Ta kontakt med:
- Telefonnummer: (816) 643-4153
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Springfield, Missouri, Forente stater, 65807
- Rekruttering
- Clinvest Headlands Llc
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Ta kontakt med:
- Telefonnummer: (417) 883-7889
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St Louis, Missouri, Forente stater, 63141
- Rekruttering
- Sundance Clinical Research
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Ta kontakt med:
- Telefonnummer: (314) 567-3377
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Nevada
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Las Vegas, Nevada, Forente stater, 89109
- Rekruttering
- Excel Clinical Research
-
Ta kontakt med:
- Telefonnummer: (702) 680-1500
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Las Vegas, Nevada, Forente stater, 89119
- Rekruttering
- Redbird Research
-
Ta kontakt med:
- Telefonnummer: (702) 577-2000
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Las Vegas, Nevada, Forente stater, 89102
- Rekruttering
- Ima Clinical Research - Las Vegas
-
Ta kontakt med:
- Telefonnummer: (702) 527-7401
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Las Vegas, Nevada, Forente stater, 89118
- Rekruttering
- Wake Research Las Vegas Rainbow
-
Ta kontakt med:
- Telefonnummer: (702) 893-8968
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Las Vegas, Nevada, Forente stater, 89119
- Rekruttering
- AMR Clinical - Las Vegas
-
Ta kontakt med:
- Telefonnummer: (702) 529-0153
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North Las Vegas, Nevada, Forente stater, 89030
- Rekruttering
- Las Vegas Clinical Trials
-
Ta kontakt med:
- Telefonnummer: (702) 637-3223
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Reno, Nevada, Forente stater, 89511
- Rekruttering
- Advanced Research Institute - Reno
-
Ta kontakt med:
- Telefonnummer: (775) 502-1616
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87102
- Rekruttering
- Albuquerque Clinical Trials
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Ta kontakt med:
- Telefonnummer: (505) 224-7407
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New York
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Amherst, New York, Forente stater, 14226
- Rekruttering
- Dent Neuro Institute, Buffalo
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Ta kontakt med:
- Telefonnummer: (716) 250-2017
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Brooklyn, New York, Forente stater, 11235
- Rekruttering
- SPRI Clinical Trials, LLC
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Ta kontakt med:
- Telefonnummer: (646) 747-4060
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Commack, New York, Forente stater, 11725
- Rekruttering
- True North Neurology
-
Ta kontakt med:
- Telefonnummer: (631) 364-9119
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Manlius, New York, Forente stater, 13104
- Rekruttering
- Central New York Clinical Research
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Ta kontakt med:
- Telefonnummer: (315) 682-3263
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New York, New York, Forente stater, 10017
- Rekruttering
- Fieve Clinical Research, Inc
-
Ta kontakt med:
- Telefonnummer: (212) 772-3570
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Rochester, New York, Forente stater, 14609
- Rekruttering
- Rochester Clinical Research
-
Ta kontakt med:
- Telefonnummer: (585) 288-0890
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Williamsville, New York, Forente stater, 14221
- Rekruttering
- Upstate Clinical Research Associates
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Ta kontakt med:
- Telefonnummer: (716) 626-6320
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North Carolina
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Charlotte, North Carolina, Forente stater, 28277
- Rekruttering
- Onsite Clinical Solutions
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Ta kontakt med:
- Telefonnummer: (800) 785-3150
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Greensboro, North Carolina, Forente stater, 27405
- Rekruttering
- Headache Wellness Center
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Ta kontakt med:
- Telefonnummer: (336) 574-8000
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Greensboro, North Carolina, Forente stater, 27405
- Rekruttering
- Guildford Neurologic Research Partners, LLC
-
Ta kontakt med:
- Telefonnummer: (336) 516-9103
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Raleigh, North Carolina, Forente stater, 27607
- Rekruttering
- Eximia Research - NC, LLC
-
Ta kontakt med:
- Telefonnummer: (919) 800-5154
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Shelby, North Carolina, Forente stater, 28150
- Rekruttering
- Carolina Research Center, Inc
-
Ta kontakt med:
- Telefonnummer: (704) 487-5228
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Ohio
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Columbus, Ohio, Forente stater, 43228
- Rekruttering
- Hometown Research
-
Ta kontakt med:
- Telefonnummer: (614) 362-3980
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Milford, Ohio, Forente stater, 45150
- Rekruttering
- Hometown Research
-
Ta kontakt med:
- Telefonnummer: (513) 831-5900
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West Chester, Ohio, Forente stater, 45069
- Rekruttering
- CincyScience
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Ta kontakt med:
- Telefonnummer: (513) 646-4864
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Oklahoma
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Edmond, Oklahoma, Forente stater, 73034
- Rekruttering
- OK Clinical Research, LLC
-
Ta kontakt med:
- Telefonnummer: (405) 285-6811
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Oklahoma City, Oklahoma, Forente stater, 73102
- Rekruttering
- Hightower Clinical
-
Ta kontakt med:
- Telefonnummer: (405) 479-8331
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Tulsa, Oklahoma, Forente stater, 74133
- Rekruttering
- DelRicht Research
-
Ta kontakt med:
- Telefonnummer: (918) 932-2276
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Yukon, Oklahoma, Forente stater, 73099
- Rekruttering
- Tekton Research, Inc.
-
Ta kontakt med:
- Telefonnummer: (405) 281-3433
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Oregon
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Portland, Oregon, Forente stater, 97210
- Rekruttering
- Summit Research Network
-
Ta kontakt med:
- Telefonnummer: (855) 367-8834
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Portland, Oregon, Forente stater, 97223
- Rekruttering
- Advanced Research Institute - Portland
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Ta kontakt med:
- Telefonnummer: (503) 610-0033
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Pennsylvania
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Allentown, Pennsylvania, Forente stater, 18103
- Rekruttering
- Lehigh Center For Clinical Research
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Ta kontakt med:
- Telefonnummer: (818) 578-4555
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Philadelphia, Pennsylvania, Forente stater, 19114
- Rekruttering
- Clinical Research Philadelphia
-
Ta kontakt med:
- Telefonnummer: (215) 676-6696
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Pittsburgh, Pennsylvania, Forente stater, 15236
- Rekruttering
- Preferred Primary Care Physicians, Inc.
-
Ta kontakt med:
- Telefonnummer: (412) 650-6155
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Scottdale, Pennsylvania, Forente stater, 15683
- Rekruttering
- Frontier Clinical Research, LLC
-
Ta kontakt med:
- Telefonnummer: (724) 220-5281
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Smithfield, Pennsylvania, Forente stater, 15478
- Rekruttering
- Frontier Clinical Research, LLC
-
Ta kontakt med:
- Telefonnummer: (724) 569-8036
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South Carolina
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North Charleston, South Carolina, Forente stater, 29405
- Rekruttering
- Coastal Carolina Research Center
-
Ta kontakt med:
- Telefonnummer: (843) 856-3784
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37421
- Rekruttering
- WR-ClinSearch, LLC
-
Ta kontakt med:
- Telefonnummer: (423) 698-4584
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Clinical Research Associates, Inc.
-
Ta kontakt med:
- Telefonnummer: (615) 329-0197
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Access Clinical Trials, Inc
-
Ta kontakt med:
- Telefonnummer: (615) 320-6076
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Texas
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Austin, Texas, Forente stater, 78731
- Rekruttering
- FutureSearch Trials of Neurology
-
Ta kontakt med:
- Telefonnummer: (512) 380-9925
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Austin, Texas, Forente stater, 78745
- Rekruttering
- Tekton Research
-
Ta kontakt med:
- Telefonnummer: (512) 859-3834
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Cypress, Texas, Forente stater, 77372
- Rekruttering
- APD Clinical Research
-
Ta kontakt med:
- Telefonnummer: (281) 315-4986
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Cypress, Texas, Forente stater, 77429
- Rekruttering
- Horizon Clinical Research and Gill Neuroscience
-
Ta kontakt med:
- Telefonnummer: (949) 491-0710
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Dallas, Texas, Forente stater, 75251
- Rekruttering
- FutureSearch Trials of Dallas, LP
-
Ta kontakt med:
- Telefonnummer: (214) 361-7700
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Houston, Texas, Forente stater, 77081
- Rekruttering
- DM Clinical Research
-
Ta kontakt med:
- Telefonnummer: (346) 550-9559
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Houston, Texas, Forente stater, 77024
- Rekruttering
- Victorium Clinical Research
-
Ta kontakt med:
- Telefonnummer: (832) 203-7026
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Lampasas, Texas, Forente stater, 76550
- Rekruttering
- GMG Clinical Research, LLC dba Radiance Clinical Research
-
Ta kontakt med:
- Telefonnummer: (512) 556-4130
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Plano, Texas, Forente stater, 75093
- Rekruttering
- AIM Trials, LLC
-
Ta kontakt med:
- Telefonnummer: (214) 856-2778
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Waxahachie, Texas, Forente stater, 75165
- Rekruttering
- ClinPoint Trials
-
Ta kontakt med:
- Telefonnummer: (972) 937-1640
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Utah
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Bountiful, Utah, Forente stater, 84010
- Rekruttering
- Pantheon Clinical Research
-
Ta kontakt med:
- Telefonnummer: (385) 281-0550
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Draper, Utah, Forente stater, 84020
- Rekruttering
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Ta kontakt med:
- Telefonnummer: 3511 (801) 365-1032
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Ogden, Utah, Forente stater, 84405
- Rekruttering
- Advanced Research Institute
-
Ta kontakt med:
- Telefonnummer: (801) 409-2040
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Riverton, Utah, Forente stater, 84096
- Rekruttering
- Granger Medical Clinic
-
Ta kontakt med:
- Telefonnummer: (801) 302-1769
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Salt Lake City, Utah, Forente stater, 84109
- Rekruttering
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Ta kontakt med:
- Telefonnummer: 3315 (801) 486-3021
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Salt Lake City, Utah, Forente stater, 84121
- Rekruttering
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Ta kontakt med:
- Telefonnummer: 3538 (801) 365-1032
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Virginia
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Newport News, Virginia, Forente stater, 23606
- Rekruttering
- Health Research of Hampton Roads, Inc. (HRHR)
-
Ta kontakt med:
- Telefonnummer: (757) 591-8100
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Norfolk, Virginia, Forente stater, 23502
- Rekruttering
- AMR Clinical - Norfolk
-
Ta kontakt med:
- Telefonnummer: (757) 614-1001
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Washington
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Seattle, Washington, Forente stater, 98104
- Rekruttering
- Seattle Clinical Research Center
-
Ta kontakt med:
- Telefonnummer: (206) 522-3330
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West Virginia
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Morgantown, West Virginia, Forente stater, 26505
- Rekruttering
- Frontier Clinical Research
-
Ta kontakt med:
- Telefonnummer: (304) 241-1648
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Wisconsin
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Kenosha, Wisconsin, Forente stater, 53144
- Rekruttering
- Clinical Investigation Specialists, Inc.
-
Ta kontakt med:
- Telefonnummer: (847) 406-8080
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Administreres oralt
|
|
Eksperimentell: Elismetrep 10 mg
|
Administered orally
Andre navn:
|
|
Eksperimentell: Elismetrep 20 mg
|
Administered orally
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain freedom at 2 hours post-dose
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain relief at 2 hours post-dose
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Up to 8 days post-dose
|
Up to 8 days post-dose
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2026
Primær fullføring (Antatt)
1. februar 2027
Studiet fullført (Antatt)
1. februar 2027
Datoer for studieregistrering
Først innsendt
9. juni 2026
Først innsendt som oppfylte QC-kriteriene
9. juni 2026
Først lagt ut (Faktiske)
12. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- K-304 P003
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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