A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
9. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1800
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Annemarie Vance
- Telefonnummer: 917-336-3654
- E-mail: annemarie@kallyope.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
- Central Research Associates, LLC (CRA) dba Flourish Research
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Kontakt:
- Telefonnummer: (205) 327-1077
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Mobile, Alabama, Forenede Stater, 36608
- AMR Mobile
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Kontakt:
- Telefonnummer: (251) 901-2127
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Arizona
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Chandler, Arizona, Forenede Stater, 85286
- TrialSphere
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Kontakt:
- Telefonnummer: (623) 267-8314
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Clinical Research
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Kontakt:
- Telefonnummer: (501) 480-5088
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California
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Colton, California, Forenede Stater, 92324
- Axiom Research, LLC
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Kontakt:
- Telefonnummer: (909) 824-2325
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Culver City, California, Forenede Stater, 90230
- ProScience Research Group
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Kontakt:
- Telefonnummer: (424) 227-8127
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Encino, California, Forenede Stater, 91316
- Leading Edge Research LA, LLC
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Kontakt:
- Telefonnummer: (818) 578-4555
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Irvine, California, Forenede Stater, 92604
- Axiom Research, Orange County
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Kontakt:
- Telefonnummer: (909) 824-2325
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Los Angeles, California, Forenede Stater, 90048
- Clinical Research Institute
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Kontakt:
- Telefonnummer: (323) 879-9999
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Los Angeles, California, Forenede Stater, 90017
- Downtown L.A. Research Center, Inc.
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Kontakt:
- Telefonnummer: (213) 261-3680
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Mission Viejo, California, Forenede Stater, 92691
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Kontakt:
- Telefonnummer: (949) 752-7910
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Oceanside, California, Forenede Stater, 92056
- Excell Research
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Kontakt:
- Telefonnummer: (760) 758-2222
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Pomona, California, Forenede Stater, 91767
- The Neurology Group
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Kontakt:
- Telefonnummer: 603 (909) 982-2719
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Pomona, California, Forenede Stater, 91767
- Empire Clinical Research
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Kontakt:
- Telefonnummer: (909) 981-5321
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Riverside, California, Forenede Stater, 92503
- Artemis Institute for Clinical Research
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Kontakt:
- Telefonnummer: (855) 367-8834
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San Diego, California, Forenede Stater, 92120
- Acclaim Clinical Research
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Kontakt:
- Telefonnummer: (855) 367-8834
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Sherman Oaks, California, Forenede Stater, 91403
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Kontakt:
- Telefonnummer: (818) 990-2671
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Spring Valley, California, Forenede Stater, 91978
- Encompass Clinical Research
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Kontakt:
- Telefonnummer: (619) 660-9068
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Walnut Creek, California, Forenede Stater, 94598
- Diablo Clinical Research
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Kontakt:
- Telefonnummer: (925) 930-7267
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Walnut Creek, California, Forenede Stater, 94596
- Sunwise Clinical Research
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Kontakt:
- Telefonnummer: (925) 298-5147
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West Covina, California, Forenede Stater, 91790
- Kinetic Clinical Research
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Kontakt:
- Telefonnummer: (657) 230-7120
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West Hills, California, Forenede Stater, 91307
- Focus Clinical Research
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Kontakt:
- Telefonnummer: (818) 253-8966
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Colorado
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Centennial, Colorado, Forenede Stater, 80112
- IMMUNOe Research Centers
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Kontakt:
- Telefonnummer: (303) 771-9000
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Colorado Springs, Colorado, Forenede Stater, 80910
- MCB Clinical Research Centers
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Kontakt:
- Telefonnummer: (719) 634-6576
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Fort Collins, Colorado, Forenede Stater, 80528
- Advanced Neurosciences Research
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Kontakt:
- Telefonnummer: (970) 226-6111
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Connecticut
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Waterbury, Connecticut, Forenede Stater, 06708
- Chase Medical Research, LLC
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Kontakt:
- Telefonnummer: (203) 419-4404
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Georgia
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Atlanta, Georgia, Forenede Stater, 30329
- DelRicht Research
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Kontakt:
- Telefonnummer: (770) 417-4454
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Marietta, Georgia, Forenede Stater, 30060
- Drug Studies America
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Kontakt:
- Telefonnummer: (678) 581-5252
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Stockbridge, Georgia, Forenede Stater, 30281
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Kontakt:
- Telefonnummer: (770) 626-0177
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Illinois
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Chicago, Illinois, Forenede Stater, 60607
- Cedar Crosse Research Center
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Kontakt:
- Telefonnummer: (312) 431-6780
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Chicago, Illinois, Forenede Stater, 60657
- Chicago Headache Center & Research Institute
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Kontakt:
- Telefonnummer: (773) 935-1000
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Flossmoor, Illinois, Forenede Stater, 60477
- Healthcare Research Network II, LLC
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Kontakt:
- Telefonnummer: (708) 388-2245
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Naperville, Illinois, Forenede Stater, 60563
- Chicago Headache Center & Research Institute
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Kontakt:
- Telefonnummer: (415) 397-0700
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Iowa
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West Des Moines, Iowa, Forenede Stater, 50265
- Integrated Clinical Trials Solution
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Kontakt:
- Telefonnummer: (515) 223-2300
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Kansas
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Overland Park, Kansas, Forenede Stater, 66212
- Collective Medical Research
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Kontakt:
- Telefonnummer: (913) 381-7180
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Overland Park, Kansas, Forenede Stater, 66214
- Clinical Associates Midwest, LLC
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Kontakt:
- Telefonnummer: (913) 359-5699
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Wichita, Kansas, Forenede Stater, 67207
- Heartland Research Associates, LLC - An AMR Company
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Kontakt:
- Telefonnummer: (316) 689-6635
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Kentucky
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Bardstown, Kentucky, Forenede Stater, 40004
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Kontakt:
- Telefonnummer: (502) 349-1569
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Lexington, Kentucky, Forenede Stater, 40509
- AMR Clinical - Lexington
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Kontakt:
- Telefonnummer: (859) 264-8999
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Lexington, Kentucky, Forenede Stater, 45212
- CTI Clinical Research Center
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Kontakt:
- Telefonnummer: (513) 721-3868
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Louisville, Kentucky, Forenede Stater, 40213
- Monroe Biomedical Research (former L-MARC Research Center)
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Kontakt:
- Telefonnummer: (502) 305-1010
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Louisiana
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Chalmette, Louisiana, Forenede Stater, 70043
- Crescent City Headache & Neurology Center
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Kontakt:
- Telefonnummer: (504) 418-6040
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New Orleans, Louisiana, Forenede Stater, 70115
- DelRicht Research
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Kontakt:
- Telefonnummer: (504) 336-2667
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Maryland
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Pikesville, Maryland, Forenede Stater, 21208
- Headlands Research - Pharmasite
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Kontakt:
- Telefonnummer: (410) 602-1440
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02131
- Boston Clinical Trials - Alcanza
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Kontakt:
- Telefonnummer: (843) 856-3784
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Waltham, Massachusetts, Forenede Stater, 02451
- MedVadis Research Corporation, LLC
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Kontakt:
- Telefonnummer: (781) 373-2940
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48104
- Michigan Headache Pain & Neurological Institute
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Kontakt:
- Telefonnummer: Option 4 (734) 677-6000
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Minnesota
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Burnsville, Minnesota, Forenede Stater, 55337
- Minneapolis Clinic of Neurology
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Kontakt:
- Telefonnummer: (763) 302-4162
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Minneapolis, Minnesota, Forenede Stater, 55402
- Clinical Research Institute
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Kontakt:
- Telefonnummer: 5 (612) 333-2200
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Mississippi
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Gulfport, Mississippi, Forenede Stater, 39503
- DelRicht Research
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Kontakt:
- Telefonnummer: (228) 588-8268
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Ridgeland, Mississippi, Forenede Stater, 39157
- Proven Endpoints
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Kontakt:
- Telefonnummer: (601) 790-1811
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Missouri
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City of Saint Peters, Missouri, Forenede Stater, 63303
- StudyMetrix Research
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Kontakt:
- Telefonnummer: (636) 387-5100
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Hazelwood, Missouri, Forenede Stater, 63042
- Healthcare Research Network
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Kontakt:
- Telefonnummer: (314) 972-9600
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Kansas City, Missouri, Forenede Stater, 64114
- AMR Clinical - Kansas City
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Kontakt:
- Telefonnummer: (816) 643-4153
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Springfield, Missouri, Forenede Stater, 65807
- Clinvest Headlands LLC
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Kontakt:
- Telefonnummer: (417) 883-7889
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St Louis, Missouri, Forenede Stater, 63141
- Sundance Clinical Research
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Kontakt:
- Telefonnummer: (314) 567-3377
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109
- Excel Clinical Research
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Kontakt:
- Telefonnummer: (702) 680-1500
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Las Vegas, Nevada, Forenede Stater, 89119
- Redbird Research
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Kontakt:
- Telefonnummer: (702) 577-2000
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Las Vegas, Nevada, Forenede Stater, 89102
- IMA Clinical Research - Las Vegas
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Kontakt:
- Telefonnummer: (702) 527-7401
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Las Vegas, Nevada, Forenede Stater, 89119
- AMR Clinical - Las Vegas
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Kontakt:
- Telefonnummer: (702) 529-0153
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Las Vegas, Nevada, Forenede Stater, 89118
- Wake Research Las Vegas Rainbow
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Kontakt:
- Telefonnummer: (702) 893-8968
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North Las Vegas, Nevada, Forenede Stater, 89030
- Las Vegas Clinical Trials
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Kontakt:
- Telefonnummer: (702) 637-3223
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Reno, Nevada, Forenede Stater, 89511
- Advanced Research Institute - Reno
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Kontakt:
- Telefonnummer: (775) 502-1616
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Albuquerque Clinical Trials
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Kontakt:
- Telefonnummer: (505) 224-7407
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New York
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Amherst, New York, Forenede Stater, 14226
- Dent Neuro Institute, Buffalo
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Kontakt:
- Telefonnummer: (716) 250-2017
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Brooklyn, New York, Forenede Stater, 11235
- SPRI Clinical Trials, LLC
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Kontakt:
- Telefonnummer: (646) 747-4060
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Commack, New York, Forenede Stater, 11725
- True North Neurology
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Kontakt:
- Telefonnummer: (631) 364-9119
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Manlius, New York, Forenede Stater, 13104
- Central New York Clinical Research
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Kontakt:
- Telefonnummer: (315) 682-3263
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New York, New York, Forenede Stater, 10017
- Fieve Clinical Research, Inc
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Kontakt:
- Telefonnummer: (212) 772-3570
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Rochester, New York, Forenede Stater, 14609
- Rochester Clinical Research
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Kontakt:
- Telefonnummer: (585) 288-0890
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Williamsville, New York, Forenede Stater, 14221
- Upstate Clinical Research Associates
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Kontakt:
- Telefonnummer: (716) 626-6320
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28277
- OnSite Clinical Solutions
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Kontakt:
- Telefonnummer: (800) 785-3150
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Greensboro, North Carolina, Forenede Stater, 27405
- Headache Wellness Center
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Kontakt:
- Telefonnummer: (336) 574-8000
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Greensboro, North Carolina, Forenede Stater, 27405
- Guildford Neurologic Research Partners, LLC
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Kontakt:
- Telefonnummer: (336) 516-9103
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Raleigh, North Carolina, Forenede Stater, 27607
- Eximia Research - NC, LLC
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Kontakt:
- Telefonnummer: (919) 800-5154
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Shelby, North Carolina, Forenede Stater, 28150
- Carolina Research Center, Inc
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Kontakt:
- Telefonnummer: (704) 487-5228
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Ohio
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Columbus, Ohio, Forenede Stater, 43228
- Hometown Research
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Kontakt:
- Telefonnummer: (614) 362-3980
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Huber Heights, Ohio, Forenede Stater, 45424
- Hometown Research
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Kontakt:
- Telefonnummer: (937) 912-4364
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Milford, Ohio, Forenede Stater, 45150
- Hometown Research
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Kontakt:
- Telefonnummer: (513) 831-5900
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West Chester, Ohio, Forenede Stater, 45069
- CincyScience
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Kontakt:
- Telefonnummer: (513) 646-4864
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Oklahoma
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Edmond, Oklahoma, Forenede Stater, 73034
- OK Clinical Research, LLC
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Kontakt:
- Telefonnummer: (405) 285-6811
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Oklahoma City, Oklahoma, Forenede Stater, 73102
- Hightower Clinical
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Kontakt:
- Telefonnummer: (405) 479-8331
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Tulsa, Oklahoma, Forenede Stater, 74133
- DelRicht Research
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Kontakt:
- Telefonnummer: (918) 932-2276
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Yukon, Oklahoma, Forenede Stater, 73099
- Tekton Research, Inc.
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Kontakt:
- Telefonnummer: (405) 281-3433
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- Summit Research Network
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Kontakt:
- Telefonnummer: (855) 367-8834
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Portland, Oregon, Forenede Stater, 97223
- Advanced Research Institute - Portland
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Kontakt:
- Telefonnummer: (503) 610-0033
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18103
- Lehigh Center for Clinical Research
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Kontakt:
- Telefonnummer: (818) 578-4555
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Philadelphia, Pennsylvania, Forenede Stater, 19114
- Clinical Research Philadelphia
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Kontakt:
- Telefonnummer: (215) 676-6696
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Pittsburgh, Pennsylvania, Forenede Stater, 15236
- Preferred Primary Care Physicians, Inc.
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Kontakt:
- Telefonnummer: (412) 650-6155
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Scottdale, Pennsylvania, Forenede Stater, 15683
- Frontier Clinical Research, LLC
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Kontakt:
- Telefonnummer: (724) 220-5281
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Smithfield, Pennsylvania, Forenede Stater, 15478
- Frontier Clinical Research, LLC
-
Kontakt:
- Telefonnummer: (724) 569-8036
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South Carolina
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North Charleston, South Carolina, Forenede Stater, 29405
- Coastal Carolina Research Center
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Kontakt:
- Telefonnummer: (843) 856-3784
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37421
- WR-ClinSearch, LLC
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Kontakt:
- Telefonnummer: (423) 698-4584
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Nashville, Tennessee, Forenede Stater, 37203
- Access Clinical Trials, Inc
-
Kontakt:
- Telefonnummer: (615) 320-6076
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Nashville, Tennessee, Forenede Stater, 37203
- Clinical Research Associates, Inc.
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Kontakt:
- Telefonnummer: (615) 329-0197
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Texas
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Austin, Texas, Forenede Stater, 78731
- FutureSearch Trials of Neurology
-
Kontakt:
- Telefonnummer: (512) 380-9925
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Austin, Texas, Forenede Stater, 78745
- Tekton Research
-
Kontakt:
- Telefonnummer: (512) 859-3834
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Cypress, Texas, Forenede Stater, 77372
- APD Clinical Research
-
Kontakt:
- Telefonnummer: (281) 315-4986
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Cypress, Texas, Forenede Stater, 77429
- Horizon Clinical Research and Gill Neuroscience
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Kontakt:
- Telefonnummer: (949) 491-0710
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Dallas, Texas, Forenede Stater, 75243
- Relaro Medical Trials, LLC
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Kontakt:
- Telefonnummer: (469) 730-3282
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Dallas, Texas, Forenede Stater, 75251
- FutureSearch Trials of Dallas, LP
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Kontakt:
- Telefonnummer: (214) 361-7700
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Fort Worth, Texas, Forenede Stater, 76104
- Helios CR, Inc. - Fort Worth
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Kontakt:
- Telefonnummer: (817) 348-0228
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Houston, Texas, Forenede Stater, 77024
- Victorium Clinical Research
-
Kontakt:
- Telefonnummer: (832) 203-7026
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Houston, Texas, Forenede Stater, 77081
- DM Clinical Research
-
Kontakt:
- Telefonnummer: (346) 550-9559
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Keller, Texas, Forenede Stater, 76248
- Helios CR, Inc. - Keller
-
Kontakt:
- Telefonnummer: (682) 774-8013
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Lampasas, Texas, Forenede Stater, 76550
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Kontakt:
- Telefonnummer: (512) 556-4130
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Plano, Texas, Forenede Stater, 75093
- Aim Trials, LLC
-
Kontakt:
- Telefonnummer: (214) 856-2778
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Waxahachie, Texas, Forenede Stater, 75165
- Clinpoint Trials
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Kontakt:
- Telefonnummer: (972) 937-1640
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Utah
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Bountiful, Utah, Forenede Stater, 84010
- Pantheon Clinical Research
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Kontakt:
- Telefonnummer: (385) 281-0550
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Draper, Utah, Forenede Stater, 84020
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Kontakt:
- Telefonnummer: 3511 (801) 365-1032
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Ogden, Utah, Forenede Stater, 84405
- Advanced Research Institute
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Kontakt:
- Telefonnummer: (801) 409-2040
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Riverton, Utah, Forenede Stater, 84096
- Granger Medical Clinic
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Kontakt:
- Telefonnummer: (801) 302-1769
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Salt Lake City, Utah, Forenede Stater, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Kontakt:
- Telefonnummer: 3315 (801) 486-3021
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Salt Lake City, Utah, Forenede Stater, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic
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Kontakt:
- Telefonnummer: 3538 (801) 365-1032
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Virginia
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Newport News, Virginia, Forenede Stater, 23606
- Health Research of Hampton Roads, Inc. (HRHR)
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Kontakt:
- Telefonnummer: (757) 591-8100
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Norfolk, Virginia, Forenede Stater, 23502
- AMR Clinical - Norfolk
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Kontakt:
- Telefonnummer: (757) 614-1001
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Seattle Clinical Research Center
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Kontakt:
- Telefonnummer: (206) 522-3330
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26505
- Frontier Clinical Research
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Kontakt:
- Telefonnummer: (304) 241-1648
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Wisconsin
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Kenosha, Wisconsin, Forenede Stater, 53144
- Clinical Investigation Specialists, Inc.
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Kontakt:
- Telefonnummer: (847) 406-8080
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-
-
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San Juan, Puerto Rico, 00907
- Solace Clinical Research
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Kontakt:
- Telefonnummer: (787) 425-4881
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
1. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent. 2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements:
a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:
- A minimum of 12 months of spontaneous amenorrhea or
- A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level > 40 mIU/mL or
- At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.
Acceptable methods of birth control are:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).
- Intrauterine device (IUD);
- Intrauterine hormone-releasing system (IUS);
- Bilateral tubal occlusion;
- Vasectomized partner;
- Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;
- Male or female condom with or without spermicide;
- Cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).
5. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.
Exclusion Criteria:
Participants are excluded from the trial if any of the following criteria apply:
Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial.
Migraine history-related
- Has difficulty distinguishing his/her migraine attacks from tension-type headaches.
- Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.
- Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).
- Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.
- Was >50 years old at age of first migraine onset.
Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening.
Medical history related
- Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine [Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study].
- Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 2 months or suicidal behavior in the past 6 months.
- Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.
- Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.
- Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.
- Has a history of human immunodeficiency virus disease.
Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption.
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Indgives oralt
|
|
Eksperimentel: Elismetrep 10 mg
|
Administered orally
Andre navne:
|
|
Eksperimentel: Elismetrep 20 mg
|
Administered orally
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain freedom at 2 hours post-dose
Tidsramme: Two hours post-dose
|
Percentage of participants that report no pain at 2 hours post-dose.
Pain will be measured on a 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
|
Two hours post-dose
|
|
Freedom from most bothersome symptoms (MBS) at 2 hours post-dose
Tidsramme: Two hours post-dose
|
Percentage of participants that report absence of their MBS (nausea, phonophobia, or photophobia) at 2 hours post-dose.
MBS will be measured using a binary scale (0=absent, 1=present).
|
Two hours post-dose
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain relief at 2 hours post-dose
Tidsramme: Two hours post-dose
|
Percentage of participants that report a pain level of moderate of severe (responses of 2 or 3 on the 4-point Likert scale) at baseline and then report a pain level of none or mild (responses of 0 or 1 on the 4-point Likert scale) at 2 hours post-dose.
|
Two hours post-dose
|
|
Sustained pain freedom from 2 to 48 hours post-dose
Tidsramme: From 2 to 48 hours post-dose
|
Percentage of participants that do not use any rescue medication, do not experience any headache pain through the time period of interest, and do not have missing pain data at 2, 24, or 48hours post-dose.
|
From 2 to 48 hours post-dose
|
|
Freedom from functional disability at 2 hours post-dose
Tidsramme: Two hours post-dose
|
Percentage of participants that self-report as being able to function normally on the functional disability scale in the subset of participants that reported any level of disability at baseline.
The scale has a 4-point numeric rating: normal (0); mildly impaired (1); moderately impaired (2); severely impaired, requires bedrest (3).
|
Two hours post-dose
|
|
Pain relief at 60 minutes post-dose
Tidsramme: Sixty minutes post-dose
|
Percentage of participants that report a pain level of moderate of severe (responses of 2 or 3 on the 4-point Likert scale) at baseline and then report a pain level of none or mild (responses of 0 or 1 on the 4-point Likert scale) at 60 minutes post-dose
|
Sixty minutes post-dose
|
|
Proportion requiring rescue medication within 24 hours post-dose
Tidsramme: Within 24 hours post-dose
|
Percentage of participants that take rescue medication within 24 hours post-dose.
|
Within 24 hours post-dose
|
|
Freedom from photophobia at 2 hours post-dose
Tidsramme: Two hours post-dose
|
Percentage of participants that report the absence of photophobia at 2 hours post-dose in the subset of participants that reported the presence of photophobia at baseline.
|
Two hours post-dose
|
|
Freedom from phonophobia at 2 hours post-dose
Tidsramme: Two hours post-dose
|
Percentage of participants that report the absence of phonophobia at 2 hours post-dose in the subset of participants that reported the presence of phonophobia at baseline.
|
Two hours post-dose
|
|
Freedom from nausea at 2 hours post-dose
Tidsramme: Two hours post-dose
|
Percentage of participants that report the absence of nausea at 2 hours post-dose in the subset of participants that reported the presence of nausea at baseline.
|
Two hours post-dose
|
|
Sustained pain freedom from 2 to 24 hours post-dose
Tidsramme: From 2 to 24 hours post-dose
|
Percentage of participants that do not use any rescue medication, do not experience any headache pain through the time period of interest, and do not have missing pain data at 2 or 24 hours post-dose.
|
From 2 to 24 hours post-dose
|
|
Sustained pain relief from 2 to 48 hours post-dose
Tidsramme: From 2 to 48 hours post-dose
|
Percentage of participants that do not use any rescue medications, do not experience any moderate or severe headache pain through the time period of interest, and do not have missing pain data at 2, 24, or 48 hours post-dose.
|
From 2 to 48 hours post-dose
|
|
Sustained pain relief from 2 to 24 hours post-dose
Tidsramme: From 2 to 24 hours post-dose
|
Percentage of participants that do not use any rescue medications, do not experience any moderate or severe headache pain through the time period of interest, and do not have missing pain data at 2 or 24 hours post-dose.
|
From 2 to 24 hours post-dose
|
|
Pain relapse from 2 to 48 hours post-dose
Tidsramme: From 2 to 48 hours post-dose
|
Percentage of participants that are pain free at 2 hours post-dose and have (a) mild, moderate, or severe pain (response of 1, 2, or 3 on the 4-point Likert scale) at any time point after 2 hours post-dose, or (b) missing pain data at 24 hours or 48 hours after 2 hours post-dose, or (c) intervening rescue medication use at or before 48 hours post-dose.
|
From 2 to 48 hours post-dose
|
|
Percentage of participants who experience one or more treatment-emergent adverse events (AEs)
Tidsramme: Up to 8 days post-dose
|
Up to 8 days post-dose
|
|
|
Percentage of participants who experience one or more treatment-emergent serious adverse events (SAEs)
Tidsramme: Up to 8 days post-dose
|
Up to 8 days post-dose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. februar 2027
Studieafslutning (Anslået)
1. februar 2027
Datoer for studieregistrering
Først indsendt
9. juni 2026
Først indsendt, der opfyldte QC-kriterier
9. juni 2026
Først opslået (Faktiske)
12. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- K-304 P003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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