A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
9. června 2026 aktualizováno: 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.
Přehled studie
Typ studie
Intervenční
Zápis (Odhadovaný)
1800
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Annemarie Vance
- Telefonní číslo: 917-336-3654
- E-mail: annemarie@kallyope.com
Studijní místa
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San Juan, Portoriko, 00907
- Solace Clinical Research
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Kontakt:
- Telefonní číslo: (787) 425-4881
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Alabama
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Birmingham, Alabama, Spojené státy, 35205
- Central Research Associates, LLC (CRA) dba Flourish Research
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Kontakt:
- Telefonní číslo: (205) 327-1077
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Mobile, Alabama, Spojené státy, 36608
- AMR Mobile
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Kontakt:
- Telefonní číslo: (251) 901-2127
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Arizona
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Chandler, Arizona, Spojené státy, 85286
- TrialSphere
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Kontakt:
- Telefonní číslo: (623) 267-8314
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72205
- Arkansas Clinical Research
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Kontakt:
- Telefonní číslo: (501) 480-5088
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California
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Colton, California, Spojené státy, 92324
- Axiom Research, LLC
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Kontakt:
- Telefonní číslo: (909) 824-2325
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Culver City, California, Spojené státy, 90230
- ProScience Research Group
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Kontakt:
- Telefonní číslo: (424) 227-8127
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Encino, California, Spojené státy, 91316
- Leading Edge Research LA, LLC
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Kontakt:
- Telefonní číslo: (818) 578-4555
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Irvine, California, Spojené státy, 92604
- Axiom Research, Orange County
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Kontakt:
- Telefonní číslo: (909) 824-2325
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Los Angeles, California, Spojené státy, 90048
- Clinical Research Institute
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Kontakt:
- Telefonní číslo: (323) 879-9999
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Los Angeles, California, Spojené státy, 90017
- Downtown L.A. Research Center, Inc.
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Kontakt:
- Telefonní číslo: (213) 261-3680
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Mission Viejo, California, Spojené státy, 92691
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Kontakt:
- Telefonní číslo: (949) 752-7910
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Oceanside, California, Spojené státy, 92056
- Excell Research
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Kontakt:
- Telefonní číslo: (760) 758-2222
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Pomona, California, Spojené státy, 91767
- The Neurology Group
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Kontakt:
- Telefonní číslo: 603 (909) 982-2719
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Pomona, California, Spojené státy, 91767
- Empire Clinical Research
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Kontakt:
- Telefonní číslo: (909) 981-5321
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Riverside, California, Spojené státy, 92503
- Artemis Institute for Clinical Research
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Kontakt:
- Telefonní číslo: (855) 367-8834
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San Diego, California, Spojené státy, 92120
- Acclaim Clinical Research
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Kontakt:
- Telefonní číslo: (855) 367-8834
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Sherman Oaks, California, Spojené státy, 91403
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Kontakt:
- Telefonní číslo: (818) 990-2671
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Spring Valley, California, Spojené státy, 91978
- Encompass Clinical Research
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Kontakt:
- Telefonní číslo: (619) 660-9068
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Walnut Creek, California, Spojené státy, 94598
- Diablo Clinical Research
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Kontakt:
- Telefonní číslo: (925) 930-7267
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Walnut Creek, California, Spojené státy, 94596
- Sunwise Clinical Research
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Kontakt:
- Telefonní číslo: (925) 298-5147
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West Covina, California, Spojené státy, 91790
- Kinetic Clinical Research
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Kontakt:
- Telefonní číslo: (657) 230-7120
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West Hills, California, Spojené státy, 91307
- Focus Clinical Research
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Kontakt:
- Telefonní číslo: (818) 253-8966
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Colorado
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Centennial, Colorado, Spojené státy, 80112
- IMMUNOe Research Centers
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Kontakt:
- Telefonní číslo: (303) 771-9000
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Colorado Springs, Colorado, Spojené státy, 80910
- MCB Clinical Research Centers
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Kontakt:
- Telefonní číslo: (719) 634-6576
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Fort Collins, Colorado, Spojené státy, 80528
- Advanced Neurosciences Research
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Kontakt:
- Telefonní číslo: (970) 226-6111
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Connecticut
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Waterbury, Connecticut, Spojené státy, 06708
- Chase Medical Research, LLC
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Kontakt:
- Telefonní číslo: (203) 419-4404
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Georgia
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Atlanta, Georgia, Spojené státy, 30329
- DelRicht Research
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Kontakt:
- Telefonní číslo: (770) 417-4454
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Marietta, Georgia, Spojené státy, 30060
- Drug Studies America
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Kontakt:
- Telefonní číslo: (678) 581-5252
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Stockbridge, Georgia, Spojené státy, 30281
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Kontakt:
- Telefonní číslo: (770) 626-0177
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Illinois
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Chicago, Illinois, Spojené státy, 60607
- Cedar Crosse Research Center
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Kontakt:
- Telefonní číslo: (312) 431-6780
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Chicago, Illinois, Spojené státy, 60657
- Chicago Headache Center & Research Institute
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Kontakt:
- Telefonní číslo: (773) 935-1000
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Flossmoor, Illinois, Spojené státy, 60477
- Healthcare Research Network II, LLC
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Kontakt:
- Telefonní číslo: (708) 388-2245
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Naperville, Illinois, Spojené státy, 60563
- Chicago Headache Center & Research Institute
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Kontakt:
- Telefonní číslo: (415) 397-0700
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Iowa
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West Des Moines, Iowa, Spojené státy, 50265
- Integrated Clinical Trials Solution
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Kontakt:
- Telefonní číslo: (515) 223-2300
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Kansas
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Overland Park, Kansas, Spojené státy, 66212
- Collective Medical Research
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Kontakt:
- Telefonní číslo: (913) 381-7180
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Overland Park, Kansas, Spojené státy, 66214
- Clinical Associates Midwest, LLC
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Kontakt:
- Telefonní číslo: (913) 359-5699
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Wichita, Kansas, Spojené státy, 67207
- Heartland Research Associates, LLC - An AMR Company
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Kontakt:
- Telefonní číslo: (316) 689-6635
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Kentucky
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Bardstown, Kentucky, Spojené státy, 40004
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Kontakt:
- Telefonní číslo: (502) 349-1569
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Lexington, Kentucky, Spojené státy, 40509
- AMR Clinical - Lexington
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Kontakt:
- Telefonní číslo: (859) 264-8999
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Lexington, Kentucky, Spojené státy, 45212
- CTI Clinical Research Center
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Kontakt:
- Telefonní číslo: (513) 721-3868
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Louisville, Kentucky, Spojené státy, 40213
- Monroe Biomedical Research (former L-MARC Research Center)
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Kontakt:
- Telefonní číslo: (502) 305-1010
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Louisiana
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Chalmette, Louisiana, Spojené státy, 70043
- Crescent City Headache & Neurology Center
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Kontakt:
- Telefonní číslo: (504) 418-6040
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New Orleans, Louisiana, Spojené státy, 70115
- DelRicht Research
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Kontakt:
- Telefonní číslo: (504) 336-2667
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Maryland
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Pikesville, Maryland, Spojené státy, 21208
- Headlands Research - Pharmasite
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Kontakt:
- Telefonní číslo: (410) 602-1440
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02131
- Boston Clinical Trials - Alcanza
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Kontakt:
- Telefonní číslo: (843) 856-3784
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Waltham, Massachusetts, Spojené státy, 02451
- MedVadis Research Corporation, LLC
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Kontakt:
- Telefonní číslo: (781) 373-2940
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48104
- Michigan Headache Pain & Neurological Institute
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Kontakt:
- Telefonní číslo: Option 4 (734) 677-6000
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Minnesota
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Burnsville, Minnesota, Spojené státy, 55337
- Minneapolis Clinic of Neurology
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Kontakt:
- Telefonní číslo: (763) 302-4162
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Minneapolis, Minnesota, Spojené státy, 55402
- Clinical Research Institute
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Kontakt:
- Telefonní číslo: 5 (612) 333-2200
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Mississippi
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Gulfport, Mississippi, Spojené státy, 39503
- DelRicht Research
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Kontakt:
- Telefonní číslo: (228) 588-8268
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Ridgeland, Mississippi, Spojené státy, 39157
- Proven Endpoints
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Kontakt:
- Telefonní číslo: (601) 790-1811
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Missouri
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City of Saint Peters, Missouri, Spojené státy, 63303
- StudyMetrix Research
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Kontakt:
- Telefonní číslo: (636) 387-5100
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Hazelwood, Missouri, Spojené státy, 63042
- Healthcare Research Network
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Kontakt:
- Telefonní číslo: (314) 972-9600
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Kansas City, Missouri, Spojené státy, 64114
- AMR Clinical - Kansas City
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Kontakt:
- Telefonní číslo: (816) 643-4153
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Springfield, Missouri, Spojené státy, 65807
- Clinvest Headlands LLC
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Kontakt:
- Telefonní číslo: (417) 883-7889
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St Louis, Missouri, Spojené státy, 63141
- Sundance Clinical Research
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Kontakt:
- Telefonní číslo: (314) 567-3377
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Nevada
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Las Vegas, Nevada, Spojené státy, 89109
- Excel Clinical Research
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Kontakt:
- Telefonní číslo: (702) 680-1500
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Las Vegas, Nevada, Spojené státy, 89119
- Redbird Research
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Kontakt:
- Telefonní číslo: (702) 577-2000
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Las Vegas, Nevada, Spojené státy, 89102
- IMA Clinical Research - Las Vegas
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Kontakt:
- Telefonní číslo: (702) 527-7401
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Las Vegas, Nevada, Spojené státy, 89119
- AMR Clinical - Las Vegas
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Kontakt:
- Telefonní číslo: (702) 529-0153
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Las Vegas, Nevada, Spojené státy, 89118
- Wake Research Las Vegas Rainbow
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Kontakt:
- Telefonní číslo: (702) 893-8968
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North Las Vegas, Nevada, Spojené státy, 89030
- Las Vegas Clinical Trials
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Kontakt:
- Telefonní číslo: (702) 637-3223
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Reno, Nevada, Spojené státy, 89511
- Advanced Research Institute - Reno
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Kontakt:
- Telefonní číslo: (775) 502-1616
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87102
- Albuquerque Clinical Trials
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Kontakt:
- Telefonní číslo: (505) 224-7407
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New York
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Amherst, New York, Spojené státy, 14226
- Dent Neuro Institute, Buffalo
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Kontakt:
- Telefonní číslo: (716) 250-2017
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Brooklyn, New York, Spojené státy, 11235
- SPRI Clinical Trials, LLC
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Kontakt:
- Telefonní číslo: (646) 747-4060
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Commack, New York, Spojené státy, 11725
- True North Neurology
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Kontakt:
- Telefonní číslo: (631) 364-9119
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Manlius, New York, Spojené státy, 13104
- Central New York Clinical Research
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Kontakt:
- Telefonní číslo: (315) 682-3263
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New York, New York, Spojené státy, 10017
- Fieve Clinical Research, Inc
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Kontakt:
- Telefonní číslo: (212) 772-3570
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Rochester, New York, Spojené státy, 14609
- Rochester Clinical Research
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Kontakt:
- Telefonní číslo: (585) 288-0890
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Williamsville, New York, Spojené státy, 14221
- Upstate Clinical Research Associates
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Kontakt:
- Telefonní číslo: (716) 626-6320
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28277
- OnSite Clinical Solutions
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Kontakt:
- Telefonní číslo: (800) 785-3150
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Greensboro, North Carolina, Spojené státy, 27405
- Headache Wellness Center
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Kontakt:
- Telefonní číslo: (336) 574-8000
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Greensboro, North Carolina, Spojené státy, 27405
- Guildford Neurologic Research Partners, LLC
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Kontakt:
- Telefonní číslo: (336) 516-9103
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Raleigh, North Carolina, Spojené státy, 27607
- Eximia Research - NC, LLC
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Kontakt:
- Telefonní číslo: (919) 800-5154
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Shelby, North Carolina, Spojené státy, 28150
- Carolina Research Center, Inc
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Kontakt:
- Telefonní číslo: (704) 487-5228
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Ohio
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Columbus, Ohio, Spojené státy, 43228
- Hometown Research
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Kontakt:
- Telefonní číslo: (614) 362-3980
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Huber Heights, Ohio, Spojené státy, 45424
- Hometown Research
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Kontakt:
- Telefonní číslo: (937) 912-4364
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Milford, Ohio, Spojené státy, 45150
- Hometown Research
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Kontakt:
- Telefonní číslo: (513) 831-5900
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West Chester, Ohio, Spojené státy, 45069
- CincyScience
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Kontakt:
- Telefonní číslo: (513) 646-4864
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Oklahoma
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Edmond, Oklahoma, Spojené státy, 73034
- OK Clinical Research, LLC
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Kontakt:
- Telefonní číslo: (405) 285-6811
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Oklahoma City, Oklahoma, Spojené státy, 73102
- Hightower Clinical
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Kontakt:
- Telefonní číslo: (405) 479-8331
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Tulsa, Oklahoma, Spojené státy, 74133
- DelRicht Research
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Kontakt:
- Telefonní číslo: (918) 932-2276
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Yukon, Oklahoma, Spojené státy, 73099
- Tekton Research, Inc.
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Kontakt:
- Telefonní číslo: (405) 281-3433
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Oregon
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Portland, Oregon, Spojené státy, 97210
- Summit Research Network
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Kontakt:
- Telefonní číslo: (855) 367-8834
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Portland, Oregon, Spojené státy, 97223
- Advanced Research Institute - Portland
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Kontakt:
- Telefonní číslo: (503) 610-0033
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Pennsylvania
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Allentown, Pennsylvania, Spojené státy, 18103
- Lehigh Center for Clinical Research
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Kontakt:
- Telefonní číslo: (818) 578-4555
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Philadelphia, Pennsylvania, Spojené státy, 19114
- Clinical Research Philadelphia
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Kontakt:
- Telefonní číslo: (215) 676-6696
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Pittsburgh, Pennsylvania, Spojené státy, 15236
- Preferred Primary Care Physicians, Inc.
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Kontakt:
- Telefonní číslo: (412) 650-6155
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Scottdale, Pennsylvania, Spojené státy, 15683
- Frontier Clinical Research, LLC
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Kontakt:
- Telefonní číslo: (724) 220-5281
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Smithfield, Pennsylvania, Spojené státy, 15478
- Frontier Clinical Research, LLC
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Kontakt:
- Telefonní číslo: (724) 569-8036
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South Carolina
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North Charleston, South Carolina, Spojené státy, 29405
- Coastal Carolina Research Center
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Kontakt:
- Telefonní číslo: (843) 856-3784
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37421
- WR-ClinSearch, LLC
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Kontakt:
- Telefonní číslo: (423) 698-4584
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Nashville, Tennessee, Spojené státy, 37203
- Access Clinical Trials, Inc
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Kontakt:
- Telefonní číslo: (615) 320-6076
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Nashville, Tennessee, Spojené státy, 37203
- Clinical Research Associates, Inc.
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Kontakt:
- Telefonní číslo: (615) 329-0197
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Texas
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Austin, Texas, Spojené státy, 78731
- FutureSearch Trials of Neurology
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Kontakt:
- Telefonní číslo: (512) 380-9925
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Austin, Texas, Spojené státy, 78745
- Tekton Research
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Kontakt:
- Telefonní číslo: (512) 859-3834
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Cypress, Texas, Spojené státy, 77372
- APD Clinical Research
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Kontakt:
- Telefonní číslo: (281) 315-4986
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Cypress, Texas, Spojené státy, 77429
- Horizon Clinical Research and Gill Neuroscience
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Kontakt:
- Telefonní číslo: (949) 491-0710
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Dallas, Texas, Spojené státy, 75243
- Relaro Medical Trials, LLC
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Kontakt:
- Telefonní číslo: (469) 730-3282
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Dallas, Texas, Spojené státy, 75251
- FutureSearch Trials of Dallas, LP
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Kontakt:
- Telefonní číslo: (214) 361-7700
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Fort Worth, Texas, Spojené státy, 76104
- Helios CR, Inc. - Fort Worth
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Kontakt:
- Telefonní číslo: (817) 348-0228
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Houston, Texas, Spojené státy, 77024
- Victorium Clinical Research
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Kontakt:
- Telefonní číslo: (832) 203-7026
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Houston, Texas, Spojené státy, 77081
- DM Clinical Research
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Kontakt:
- Telefonní číslo: (346) 550-9559
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Keller, Texas, Spojené státy, 76248
- Helios CR, Inc. - Keller
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Kontakt:
- Telefonní číslo: (682) 774-8013
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Lampasas, Texas, Spojené státy, 76550
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Kontakt:
- Telefonní číslo: (512) 556-4130
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Plano, Texas, Spojené státy, 75093
- Aim Trials, LLC
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Kontakt:
- Telefonní číslo: (214) 856-2778
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Waxahachie, Texas, Spojené státy, 75165
- Clinpoint Trials
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Kontakt:
- Telefonní číslo: (972) 937-1640
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Utah
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Bountiful, Utah, Spojené státy, 84010
- Pantheon Clinical Research
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Kontakt:
- Telefonní číslo: (385) 281-0550
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Draper, Utah, Spojené státy, 84020
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Kontakt:
- Telefonní číslo: 3511 (801) 365-1032
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Ogden, Utah, Spojené státy, 84405
- Advanced Research Institute
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Kontakt:
- Telefonní číslo: (801) 409-2040
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Riverton, Utah, Spojené státy, 84096
- Granger Medical Clinic
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Kontakt:
- Telefonní číslo: (801) 302-1769
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Salt Lake City, Utah, Spojené státy, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Kontakt:
- Telefonní číslo: 3315 (801) 486-3021
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Salt Lake City, Utah, Spojené státy, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic
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Kontakt:
- Telefonní číslo: 3538 (801) 365-1032
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Virginia
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Newport News, Virginia, Spojené státy, 23606
- Health Research of Hampton Roads, Inc. (HRHR)
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Kontakt:
- Telefonní číslo: (757) 591-8100
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Norfolk, Virginia, Spojené státy, 23502
- AMR Clinical - Norfolk
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Kontakt:
- Telefonní číslo: (757) 614-1001
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Washington
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Seattle, Washington, Spojené státy, 98104
- Seattle Clinical Research Center
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Kontakt:
- Telefonní číslo: (206) 522-3330
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West Virginia
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Morgantown, West Virginia, Spojené státy, 26505
- Frontier Clinical Research
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Kontakt:
- Telefonní číslo: (304) 241-1648
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Wisconsin
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Kenosha, Wisconsin, Spojené státy, 53144
- Clinical Investigation Specialists, Inc.
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Kontakt:
- Telefonní číslo: (847) 406-8080
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
1. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent. 2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements:
a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:
- A minimum of 12 months of spontaneous amenorrhea or
- A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level > 40 mIU/mL or
- At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.
Acceptable methods of birth control are:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).
- Intrauterine device (IUD);
- Intrauterine hormone-releasing system (IUS);
- Bilateral tubal occlusion;
- Vasectomized partner;
- Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;
- Male or female condom with or without spermicide;
- Cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).
5. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.
Exclusion Criteria:
Participants are excluded from the trial if any of the following criteria apply:
Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial.
Migraine history-related
- Has difficulty distinguishing his/her migraine attacks from tension-type headaches.
- Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.
- Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).
- Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.
- Was >50 years old at age of first migraine onset.
Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening.
Medical history related
- Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine [Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study].
- Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 2 months or suicidal behavior in the past 6 months.
- Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.
- Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.
- Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.
- Has a history of human immunodeficiency virus disease.
Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption.
Laboratory, vital sign, and electrocardiogram related
- Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.
- Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of <30 mL/min/1.73 m2.
- Has a screening result for alanine aminotransferase or aspartate aminotransferase of >2.0 X upper limit of normal (ULN) or total bilirubin >1.5 X ULN at the Screening visit. Note: An isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range.
- Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) >450 ms for males and >470 ms for females at screening.
Has a mean value for triplicate seated systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood pressure is exclusionary on the first triplicate assessment at the Screening Visit, they may have one repeat triplicate blood pressure assessment at that visit after another rest of at least 10 minutes.
Medication use and substance abuse related
- Has known history of or suspected abuse of alcohol or recreational drugs at Screening.
- Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol [THC] or cannabidiol [CBD] within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior to screening.
Has a positive drug screen at screening. Note:
- If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the prescribing physician.
- If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatory documentation is obtained from the prescribing physician, and the stimulant medication in question is known to be detected as amphetamine on the drug screen being used.
- Is currently in violation of study requirements for prohibited and permissible concomitant medications (not already specified in other criteria) or is anticipated to violate these requirements during study participation (detailed in the protocol).
- Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
- Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.
Has a history of non-narcotic analgesic intake ≥15 days per month for
- 3 months prior to screening.
Other
- Has known or suspected hypersensitivity to trial product(s) or related products.
- Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
- Has any surgery scheduled for the duration of the trial.
- Has a screening hemoglobin <11.0 g/dL (males) or <10.0 g/dL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia).
- Has previous participation in this trial. Participation is defined as signed informed consent.
- Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of screening or ever signed an informed consent for Study K-304 P004. Note: Patients may not be screened at more than one trial site for this study.
- Has any other disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.
- Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Placebo
|
Podává se ústně
|
|
Experimentální: Elismetrep 10 mg
|
Administered orally
Ostatní jména:
|
|
Experimentální: Elismetrep 20 mg
|
Administered orally
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain freedom at 2 hours post-dose
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain relief at 2 hours post-dose
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: Up to 8 days post-dose
|
Up to 8 days post-dose
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. července 2026
Primární dokončení (Odhadovaný)
1. února 2027
Dokončení studie (Odhadovaný)
1. února 2027
Termíny zápisu do studia
První předloženo
9. června 2026
První předloženo, které splnilo kritéria kontroly kvality
9. června 2026
První zveřejněno (Aktuální)
12. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- K-304 P003
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .