A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
19 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
1800
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Annemarie Vance
- Numéro de téléphone: 917-336-3654
- E-mail: annemarie@kallyope.com
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35205
- Recrutement
- Central Research Associates, LLC (CRA) dba Flourish Research
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Contact:
- Numéro de téléphone: (205) 327-1077
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Mobile, Alabama, États-Unis, 36608
- Recrutement
- AMR Mobile
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Contact:
- Numéro de téléphone: (251) 901-2127
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Arizona
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Chandler, Arizona, États-Unis, 85286
- Recrutement
- TrialSphere
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Contact:
- Numéro de téléphone: (623) 267-8314
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- Recrutement
- Arkansas Clinical Research
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Contact:
- Numéro de téléphone: (501) 480-5088
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California
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Colton, California, États-Unis, 92324
- Recrutement
- Axiom Research, LLC
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Contact:
- Numéro de téléphone: (909) 824-2325
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Culver City, California, États-Unis, 90230
- Recrutement
- Proscience Research Group
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Contact:
- Numéro de téléphone: (424) 227-8127
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Encino, California, États-Unis, 91316
- Recrutement
- Leading Edge Research LA, LLC
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Contact:
- Numéro de téléphone: (818) 578-4555
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Irvine, California, États-Unis, 92604
- Recrutement
- Axiom Research, Orange County
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Contact:
- Numéro de téléphone: (909) 824-2325
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Los Angeles, California, États-Unis, 90048
- Recrutement
- Clinical Research Institute
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Contact:
- Numéro de téléphone: (323) 879-9999
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Los Angeles, California, États-Unis, 90017
- Recrutement
- Downtown L.A. Research Center, Inc.
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Contact:
- Numéro de téléphone: (213) 261-3680
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Mission Viejo, California, États-Unis, 92691
- Recrutement
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Contact:
- Numéro de téléphone: (949) 752-7910
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Oceanside, California, États-Unis, 92056
- Recrutement
- Excell Research
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Contact:
- Numéro de téléphone: (760) 758-2222
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Pomona, California, États-Unis, 91767
- Recrutement
- The Neurology Group
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Contact:
- Numéro de téléphone: 603 (909) 982-2719
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Pomona, California, États-Unis, 91767
- Recrutement
- Empire Clinical Research
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Contact:
- Numéro de téléphone: (909) 981-5321
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Riverside, California, États-Unis, 92503
- Recrutement
- Artemis Institute for Clinical Research
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Contact:
- Numéro de téléphone: (855) 367-8834
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San Diego, California, États-Unis, 92120
- Recrutement
- Acclaim Clinical Research
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Contact:
- Numéro de téléphone: (855) 367-8834
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Sherman Oaks, California, États-Unis, 91403
- Recrutement
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Contact:
- Numéro de téléphone: (818) 990-2671
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Spring Valley, California, États-Unis, 91978
- Recrutement
- Encompass Clinical Research
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Contact:
- Numéro de téléphone: (619) 660-9068
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Walnut Creek, California, États-Unis, 94598
- Recrutement
- Diablo Clinical Research
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Contact:
- Numéro de téléphone: (925) 930-7267
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Walnut Creek, California, États-Unis, 94596
- Recrutement
- Sunwise Clinical Research
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Contact:
- Numéro de téléphone: (925) 298-5147
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West Covina, California, États-Unis, 91790
- Recrutement
- Kinetic Clinical Research
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Contact:
- Numéro de téléphone: (657) 230-7120
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West Hills, California, États-Unis, 91307
- Recrutement
- Focus Clinical Research
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Contact:
- Numéro de téléphone: (818) 253-8966
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Colorado
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Centennial, Colorado, États-Unis, 80112
- Recrutement
- IMMUNOe Research Centers
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Contact:
- Numéro de téléphone: (303) 771-9000
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Colorado Springs, Colorado, États-Unis, 80910
- Recrutement
- MCB Clinical Research Centers
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Contact:
- Numéro de téléphone: (719) 634-6576
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Fort Collins, Colorado, États-Unis, 80528
- Recrutement
- Advanced Neurosciences Research
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Contact:
- Numéro de téléphone: (970) 226-6111
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Connecticut
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Waterbury, Connecticut, États-Unis, 06708
- Recrutement
- Chase Medical Research, LLC
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Contact:
- Numéro de téléphone: (203) 419-4404
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Georgia
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Atlanta, Georgia, États-Unis, 30329
- Recrutement
- DelRicht Research
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Contact:
- Numéro de téléphone: (770) 417-4454
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Marietta, Georgia, États-Unis, 30060
- Recrutement
- Drug Studies America
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Contact:
- Numéro de téléphone: (678) 581-5252
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Stockbridge, Georgia, États-Unis, 30281
- Recrutement
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Contact:
- Numéro de téléphone: (770) 626-0177
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Illinois
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Chicago, Illinois, États-Unis, 60607
- Recrutement
- Cedar Crosse Research Center
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Contact:
- Numéro de téléphone: (312) 431-6780
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Chicago, Illinois, États-Unis, 60657
- Recrutement
- Chicago Headache Center & Research Institute
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Contact:
- Numéro de téléphone: (773) 935-1000
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Flossmoor, Illinois, États-Unis, 60477
- Recrutement
- Healthcare Research Network II, LLC
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Contact:
- Numéro de téléphone: (708) 388-2245
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Naperville, Illinois, États-Unis, 60563
- Recrutement
- Chicago Headache Center & Research Institute
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Contact:
- Numéro de téléphone: (415) 397-0700
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Iowa
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West Des Moines, Iowa, États-Unis, 50265
- Recrutement
- Integrated Clinical Trials Solution
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Contact:
- Numéro de téléphone: (515) 223-2300
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Kansas
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Overland Park, Kansas, États-Unis, 66214
- Recrutement
- Clinical Associates Midwest, LLC
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Contact:
- Numéro de téléphone: (913) 359-5699
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Overland Park, Kansas, États-Unis, 66212
- Recrutement
- Collective Medical Research
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Contact:
- Numéro de téléphone: (913) 381-7180
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Wichita, Kansas, États-Unis, 67207
- Recrutement
- Heartland Research Associates, LLC - An AMR Company
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Contact:
- Numéro de téléphone: (316) 689-6635
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Kentucky
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Bardstown, Kentucky, États-Unis, 40004
- Recrutement
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Contact:
- Numéro de téléphone: (502) 349-1569
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Lexington, Kentucky, États-Unis, 40509
- Recrutement
- AMR Clinical - Lexington
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Contact:
- Numéro de téléphone: (859) 264-8999
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Lexington, Kentucky, États-Unis, 45212
- Recrutement
- CTI Clinical Research Center
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Contact:
- Numéro de téléphone: (513) 721-3868
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Louisiana
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Chalmette, Louisiana, États-Unis, 70043
- Recrutement
- Crescent City Headache & Neurology Center
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Contact:
- Numéro de téléphone: (504) 418-6040
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New Orleans, Louisiana, États-Unis, 70115
- Recrutement
- DelRicht Research
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Contact:
- Numéro de téléphone: (504) 336-2667
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Maryland
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Pikesville, Maryland, États-Unis, 21208
- Recrutement
- Headlands Research - Pharmasite
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Contact:
- Numéro de téléphone: (410) 602-1440
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Massachusetts
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Boston, Massachusetts, États-Unis, 02131
- Recrutement
- Boston Clinical Trials - Alcanza
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Contact:
- Numéro de téléphone: (843) 856-3784
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Waltham, Massachusetts, États-Unis, 02451
- Recrutement
- MedVadis Research Corporation, LLC
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Contact:
- Numéro de téléphone: (781) 373-2940
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Michigan
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Ann Arbor, Michigan, États-Unis, 48104
- Recrutement
- Michigan Headache Pain & Neurological Institute
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Contact:
- Numéro de téléphone: Option 4 (734) 677-6000
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55402
- Recrutement
- Clinical Research Institute
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Contact:
- Numéro de téléphone: 5 (612) 333-2200
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Mississippi
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Gulfport, Mississippi, États-Unis, 39503
- Recrutement
- DelRicht Research
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Contact:
- Numéro de téléphone: (228) 588-8268
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Ridgeland, Mississippi, États-Unis, 39157
- Recrutement
- Proven Endpoints
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Contact:
- Numéro de téléphone: (601) 790-1811
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Missouri
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City of Saint Peters, Missouri, États-Unis, 63303
- Recrutement
- StudyMetrix Research
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Contact:
- Numéro de téléphone: (636) 387-5100
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Hazelwood, Missouri, États-Unis, 63042
- Recrutement
- Healthcare Research Network
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Contact:
- Numéro de téléphone: (314) 972-9600
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Kansas City, Missouri, États-Unis, 64114
- Recrutement
- AMR Clinical - Kansas City
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Contact:
- Numéro de téléphone: (816) 643-4153
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Springfield, Missouri, États-Unis, 65807
- Recrutement
- Clinvest Headlands Llc
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Contact:
- Numéro de téléphone: (417) 883-7889
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St Louis, Missouri, États-Unis, 63141
- Recrutement
- Sundance Clinical Research
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Contact:
- Numéro de téléphone: (314) 567-3377
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Nevada
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Las Vegas, Nevada, États-Unis, 89109
- Recrutement
- Excel Clinical Research
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Contact:
- Numéro de téléphone: (702) 680-1500
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Las Vegas, Nevada, États-Unis, 89119
- Recrutement
- Redbird Research
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Contact:
- Numéro de téléphone: (702) 577-2000
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Las Vegas, Nevada, États-Unis, 89102
- Recrutement
- Ima Clinical Research - Las Vegas
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Contact:
- Numéro de téléphone: (702) 527-7401
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Las Vegas, Nevada, États-Unis, 89118
- Recrutement
- Wake Research Las Vegas Rainbow
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Contact:
- Numéro de téléphone: (702) 893-8968
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Las Vegas, Nevada, États-Unis, 89119
- Recrutement
- AMR Clinical - Las Vegas
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Contact:
- Numéro de téléphone: (702) 529-0153
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North Las Vegas, Nevada, États-Unis, 89030
- Recrutement
- Las Vegas Clinical Trials
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Contact:
- Numéro de téléphone: (702) 637-3223
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Reno, Nevada, États-Unis, 89511
- Recrutement
- Advanced Research Institute - Reno
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Contact:
- Numéro de téléphone: (775) 502-1616
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87102
- Recrutement
- Albuquerque Clinical Trials
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Contact:
- Numéro de téléphone: (505) 224-7407
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New York
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Amherst, New York, États-Unis, 14226
- Recrutement
- Dent Neuro Institute, Buffalo
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Contact:
- Numéro de téléphone: (716) 250-2017
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Brooklyn, New York, États-Unis, 11235
- Recrutement
- SPRI Clinical Trials, LLC
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Contact:
- Numéro de téléphone: (646) 747-4060
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Commack, New York, États-Unis, 11725
- Recrutement
- True North Neurology
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Contact:
- Numéro de téléphone: (631) 364-9119
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Manlius, New York, États-Unis, 13104
- Recrutement
- Central New York Clinical Research
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Contact:
- Numéro de téléphone: (315) 682-3263
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New York, New York, États-Unis, 10017
- Recrutement
- Fieve Clinical Research, Inc
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Contact:
- Numéro de téléphone: (212) 772-3570
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Rochester, New York, États-Unis, 14609
- Recrutement
- Rochester Clinical Research
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Contact:
- Numéro de téléphone: (585) 288-0890
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Williamsville, New York, États-Unis, 14221
- Recrutement
- Upstate Clinical Research Associates
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Contact:
- Numéro de téléphone: (716) 626-6320
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North Carolina
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Charlotte, North Carolina, États-Unis, 28277
- Recrutement
- Onsite Clinical Solutions
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Contact:
- Numéro de téléphone: (800) 785-3150
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Greensboro, North Carolina, États-Unis, 27405
- Recrutement
- Headache Wellness Center
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Contact:
- Numéro de téléphone: (336) 574-8000
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Greensboro, North Carolina, États-Unis, 27405
- Recrutement
- Guildford Neurologic Research Partners, LLC
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Contact:
- Numéro de téléphone: (336) 516-9103
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Raleigh, North Carolina, États-Unis, 27607
- Recrutement
- Eximia Research - NC, LLC
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Contact:
- Numéro de téléphone: (919) 800-5154
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Shelby, North Carolina, États-Unis, 28150
- Recrutement
- Carolina Research Center, Inc
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Contact:
- Numéro de téléphone: (704) 487-5228
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Ohio
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Columbus, Ohio, États-Unis, 43228
- Recrutement
- Hometown Research
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Contact:
- Numéro de téléphone: (614) 362-3980
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Milford, Ohio, États-Unis, 45150
- Recrutement
- Hometown Research
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Contact:
- Numéro de téléphone: (513) 831-5900
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West Chester, Ohio, États-Unis, 45069
- Recrutement
- CincyScience
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Contact:
- Numéro de téléphone: (513) 646-4864
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Oklahoma
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Edmond, Oklahoma, États-Unis, 73034
- Recrutement
- OK Clinical Research, LLC
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Contact:
- Numéro de téléphone: (405) 285-6811
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Oklahoma City, Oklahoma, États-Unis, 73102
- Recrutement
- Hightower Clinical
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Contact:
- Numéro de téléphone: (405) 479-8331
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Tulsa, Oklahoma, États-Unis, 74133
- Recrutement
- DelRicht Research
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Contact:
- Numéro de téléphone: (918) 932-2276
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Yukon, Oklahoma, États-Unis, 73099
- Recrutement
- Tekton Research, Inc.
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Contact:
- Numéro de téléphone: (405) 281-3433
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Oregon
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Portland, Oregon, États-Unis, 97210
- Recrutement
- Summit Research Network
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Contact:
- Numéro de téléphone: (855) 367-8834
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Portland, Oregon, États-Unis, 97223
- Recrutement
- Advanced Research Institute - Portland
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Contact:
- Numéro de téléphone: (503) 610-0033
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Pennsylvania
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Allentown, Pennsylvania, États-Unis, 18103
- Recrutement
- Lehigh Center For Clinical Research
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Contact:
- Numéro de téléphone: (818) 578-4555
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Philadelphia, Pennsylvania, États-Unis, 19114
- Recrutement
- Clinical Research Philadelphia
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Contact:
- Numéro de téléphone: (215) 676-6696
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Pittsburgh, Pennsylvania, États-Unis, 15236
- Recrutement
- Preferred Primary Care Physicians, Inc.
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Contact:
- Numéro de téléphone: (412) 650-6155
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Scottdale, Pennsylvania, États-Unis, 15683
- Recrutement
- Frontier Clinical Research, LLC
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Contact:
- Numéro de téléphone: (724) 220-5281
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Smithfield, Pennsylvania, États-Unis, 15478
- Recrutement
- Frontier Clinical Research, LLC
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Contact:
- Numéro de téléphone: (724) 569-8036
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South Carolina
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North Charleston, South Carolina, États-Unis, 29405
- Recrutement
- Coastal Carolina Research Center
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Contact:
- Numéro de téléphone: (843) 856-3784
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37421
- Recrutement
- WR-ClinSearch, LLC
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Contact:
- Numéro de téléphone: (423) 698-4584
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- Clinical Research Associates, Inc.
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Contact:
- Numéro de téléphone: (615) 329-0197
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- Access Clinical Trials, Inc
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Contact:
- Numéro de téléphone: (615) 320-6076
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Texas
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Austin, Texas, États-Unis, 78731
- Recrutement
- FutureSearch Trials of Neurology
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Contact:
- Numéro de téléphone: (512) 380-9925
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Austin, Texas, États-Unis, 78745
- Recrutement
- Tekton Research
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Contact:
- Numéro de téléphone: (512) 859-3834
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Cypress, Texas, États-Unis, 77372
- Recrutement
- APD Clinical Research
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Contact:
- Numéro de téléphone: (281) 315-4986
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Cypress, Texas, États-Unis, 77429
- Recrutement
- Horizon Clinical Research and Gill Neuroscience
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Contact:
- Numéro de téléphone: (949) 491-0710
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Dallas, Texas, États-Unis, 75251
- Recrutement
- FutureSearch Trials of Dallas, LP
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Contact:
- Numéro de téléphone: (214) 361-7700
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Houston, Texas, États-Unis, 77081
- Recrutement
- DM Clinical Research
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Contact:
- Numéro de téléphone: (346) 550-9559
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Houston, Texas, États-Unis, 77024
- Recrutement
- Victorium Clinical Research
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Contact:
- Numéro de téléphone: (832) 203-7026
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Lampasas, Texas, États-Unis, 76550
- Recrutement
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Contact:
- Numéro de téléphone: (512) 556-4130
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Plano, Texas, États-Unis, 75093
- Recrutement
- AIM Trials, LLC
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Contact:
- Numéro de téléphone: (214) 856-2778
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Waxahachie, Texas, États-Unis, 75165
- Recrutement
- ClinPoint Trials
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Contact:
- Numéro de téléphone: (972) 937-1640
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Utah
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Bountiful, Utah, États-Unis, 84010
- Recrutement
- Pantheon Clinical Research
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Contact:
- Numéro de téléphone: (385) 281-0550
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Draper, Utah, États-Unis, 84020
- Recrutement
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Contact:
- Numéro de téléphone: 3511 (801) 365-1032
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Ogden, Utah, États-Unis, 84405
- Recrutement
- Advanced Research Institute
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Contact:
- Numéro de téléphone: (801) 409-2040
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Riverton, Utah, États-Unis, 84096
- Recrutement
- Granger Medical Clinic
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Contact:
- Numéro de téléphone: (801) 302-1769
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Salt Lake City, Utah, États-Unis, 84109
- Recrutement
- J. Lewis Research, Inc. / Foothill Family Clinic
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Contact:
- Numéro de téléphone: 3315 (801) 486-3021
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Salt Lake City, Utah, États-Unis, 84121
- Recrutement
- J. Lewis Research, Inc. / Foothill Family Clinic
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Contact:
- Numéro de téléphone: 3538 (801) 365-1032
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Virginia
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Newport News, Virginia, États-Unis, 23606
- Recrutement
- Health Research of Hampton Roads, Inc. (HRHR)
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Contact:
- Numéro de téléphone: (757) 591-8100
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Norfolk, Virginia, États-Unis, 23502
- Recrutement
- AMR Clinical - Norfolk
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Contact:
- Numéro de téléphone: (757) 614-1001
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Washington
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Seattle, Washington, États-Unis, 98104
- Recrutement
- Seattle Clinical Research Center
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Contact:
- Numéro de téléphone: (206) 522-3330
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West Virginia
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Morgantown, West Virginia, États-Unis, 26505
- Recrutement
- Frontier Clinical Research
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Contact:
- Numéro de téléphone: (304) 241-1648
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Wisconsin
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Kenosha, Wisconsin, États-Unis, 53144
- Recrutement
- Clinical Investigation Specialists, Inc.
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Contact:
- Numéro de téléphone: (847) 406-8080
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
|
Administré par voie orale
|
|
Expérimental: Elismetrep 10 mg
|
Administered orally
Autres noms:
|
|
Expérimental: Elismetrep 20 mg
|
Administered orally
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain freedom at 2 hours post-dose
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain relief at 2 hours post-dose
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: Up to 8 days post-dose
|
Up to 8 days post-dose
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2026
Achèvement primaire (Estimé)
1 février 2027
Achèvement de l'étude (Estimé)
1 février 2027
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
9 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- K-304 P003
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .