A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
19 augusti 2026 uppdaterad av: Kallyope Inc.
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Acute Treatment of Migraine
This is a double-blind, randomized, multicenter, outpatient evaluation of the efficacy, safety, and tolerability of elismetrep, as compared with placebo, in the acute treatment of migraine.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
1800
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Annemarie Vance
- Telefonnummer: 917-336-3654
- E-post: annemarie@kallyope.com
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35205
- Rekrytering
- Central Research Associates, LLC (CRA) dba Flourish Research
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Kontakt:
- Telefonnummer: (205) 327-1077
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Mobile, Alabama, Förenta staterna, 36608
- Rekrytering
- AMR Mobile
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Kontakt:
- Telefonnummer: (251) 901-2127
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Arizona
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Chandler, Arizona, Förenta staterna, 85286
- Rekrytering
- TrialSphere
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Kontakt:
- Telefonnummer: (623) 267-8314
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- Rekrytering
- Arkansas Clinical Research
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Kontakt:
- Telefonnummer: (501) 480-5088
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California
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Colton, California, Förenta staterna, 92324
- Rekrytering
- Axiom Research, LLC
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Kontakt:
- Telefonnummer: (909) 824-2325
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Culver City, California, Förenta staterna, 90230
- Rekrytering
- Proscience Research Group
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Kontakt:
- Telefonnummer: (424) 227-8127
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Encino, California, Förenta staterna, 91316
- Rekrytering
- Leading Edge Research LA, LLC
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Kontakt:
- Telefonnummer: (818) 578-4555
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Irvine, California, Förenta staterna, 92604
- Rekrytering
- Axiom Research, Orange County
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Kontakt:
- Telefonnummer: (909) 824-2325
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Los Angeles, California, Förenta staterna, 90048
- Rekrytering
- Clinical Research Institute
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Kontakt:
- Telefonnummer: (323) 879-9999
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Los Angeles, California, Förenta staterna, 90017
- Rekrytering
- Downtown L.A. Research Center, Inc.
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Kontakt:
- Telefonnummer: (213) 261-3680
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Mission Viejo, California, Förenta staterna, 92691
- Rekrytering
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Kontakt:
- Telefonnummer: (949) 752-7910
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Oceanside, California, Förenta staterna, 92056
- Rekrytering
- Excell Research
-
Kontakt:
- Telefonnummer: (760) 758-2222
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Pomona, California, Förenta staterna, 91767
- Rekrytering
- The Neurology Group
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Kontakt:
- Telefonnummer: 603 (909) 982-2719
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Pomona, California, Förenta staterna, 91767
- Rekrytering
- Empire Clinical Research
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Kontakt:
- Telefonnummer: (909) 981-5321
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Riverside, California, Förenta staterna, 92503
- Rekrytering
- Artemis Institute for Clinical Research
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Kontakt:
- Telefonnummer: (855) 367-8834
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San Diego, California, Förenta staterna, 92120
- Rekrytering
- Acclaim Clinical Research
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Kontakt:
- Telefonnummer: (855) 367-8834
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Sherman Oaks, California, Förenta staterna, 91403
- Rekrytering
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Kontakt:
- Telefonnummer: (818) 990-2671
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Spring Valley, California, Förenta staterna, 91978
- Rekrytering
- Encompass Clinical Research
-
Kontakt:
- Telefonnummer: (619) 660-9068
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Walnut Creek, California, Förenta staterna, 94598
- Rekrytering
- Diablo Clinical Research
-
Kontakt:
- Telefonnummer: (925) 930-7267
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Walnut Creek, California, Förenta staterna, 94596
- Rekrytering
- Sunwise Clinical Research
-
Kontakt:
- Telefonnummer: (925) 298-5147
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West Covina, California, Förenta staterna, 91790
- Rekrytering
- Kinetic Clinical Research
-
Kontakt:
- Telefonnummer: (657) 230-7120
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West Hills, California, Förenta staterna, 91307
- Rekrytering
- Focus Clinical Research
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Kontakt:
- Telefonnummer: (818) 253-8966
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Colorado
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Centennial, Colorado, Förenta staterna, 80112
- Rekrytering
- IMMUNOe Research Centers
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Kontakt:
- Telefonnummer: (303) 771-9000
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Colorado Springs, Colorado, Förenta staterna, 80910
- Rekrytering
- MCB Clinical Research Centers
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Kontakt:
- Telefonnummer: (719) 634-6576
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Fort Collins, Colorado, Förenta staterna, 80528
- Rekrytering
- Advanced Neurosciences Research
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Kontakt:
- Telefonnummer: (970) 226-6111
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Connecticut
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Waterbury, Connecticut, Förenta staterna, 06708
- Rekrytering
- Chase Medical Research, LLC
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Kontakt:
- Telefonnummer: (203) 419-4404
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Georgia
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Atlanta, Georgia, Förenta staterna, 30329
- Rekrytering
- DelRicht Research
-
Kontakt:
- Telefonnummer: (770) 417-4454
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Marietta, Georgia, Förenta staterna, 30060
- Rekrytering
- Drug Studies America
-
Kontakt:
- Telefonnummer: (678) 581-5252
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Stockbridge, Georgia, Förenta staterna, 30281
- Rekrytering
- 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, Förenta staterna, 60607
- Rekrytering
- Cedar Crosse Research Center
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Kontakt:
- Telefonnummer: (312) 431-6780
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Chicago, Illinois, Förenta staterna, 60657
- Rekrytering
- Chicago Headache Center & Research Institute
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Kontakt:
- Telefonnummer: (773) 935-1000
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Flossmoor, Illinois, Förenta staterna, 60477
- Rekrytering
- Healthcare Research Network II, LLC
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Kontakt:
- Telefonnummer: (708) 388-2245
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Naperville, Illinois, Förenta staterna, 60563
- Rekrytering
- 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, Förenta staterna, 50265
- Rekrytering
- 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, Förenta staterna, 66214
- Rekrytering
- Clinical Associates Midwest, LLC
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Kontakt:
- Telefonnummer: (913) 359-5699
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Overland Park, Kansas, Förenta staterna, 66212
- Rekrytering
- Collective Medical Research
-
Kontakt:
- Telefonnummer: (913) 381-7180
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Wichita, Kansas, Förenta staterna, 67207
- Rekrytering
- 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, Förenta staterna, 40004
- Rekrytering
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Kontakt:
- Telefonnummer: (502) 349-1569
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Lexington, Kentucky, Förenta staterna, 40509
- Rekrytering
- AMR Clinical - Lexington
-
Kontakt:
- Telefonnummer: (859) 264-8999
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Lexington, Kentucky, Förenta staterna, 45212
- Rekrytering
- CTI Clinical Research Center
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Kontakt:
- Telefonnummer: (513) 721-3868
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Louisiana
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Chalmette, Louisiana, Förenta staterna, 70043
- Rekrytering
- Crescent City Headache & Neurology Center
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Kontakt:
- Telefonnummer: (504) 418-6040
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New Orleans, Louisiana, Förenta staterna, 70115
- Rekrytering
- DelRicht Research
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Kontakt:
- Telefonnummer: (504) 336-2667
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Maryland
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Pikesville, Maryland, Förenta staterna, 21208
- Rekrytering
- Headlands Research - Pharmasite
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Kontakt:
- Telefonnummer: (410) 602-1440
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02131
- Rekrytering
- Boston Clinical Trials - Alcanza
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Kontakt:
- Telefonnummer: (843) 856-3784
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Waltham, Massachusetts, Förenta staterna, 02451
- Rekrytering
- 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, Förenta staterna, 48104
- Rekrytering
- 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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Minneapolis, Minnesota, Förenta staterna, 55402
- Rekrytering
- Clinical Research Institute
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Kontakt:
- Telefonnummer: 5 (612) 333-2200
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Mississippi
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Gulfport, Mississippi, Förenta staterna, 39503
- Rekrytering
- DelRicht Research
-
Kontakt:
- Telefonnummer: (228) 588-8268
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Ridgeland, Mississippi, Förenta staterna, 39157
- Rekrytering
- 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, Förenta staterna, 63303
- Rekrytering
- StudyMetrix Research
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Kontakt:
- Telefonnummer: (636) 387-5100
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Hazelwood, Missouri, Förenta staterna, 63042
- Rekrytering
- Healthcare Research Network
-
Kontakt:
- Telefonnummer: (314) 972-9600
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Kansas City, Missouri, Förenta staterna, 64114
- Rekrytering
- AMR Clinical - Kansas City
-
Kontakt:
- Telefonnummer: (816) 643-4153
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Springfield, Missouri, Förenta staterna, 65807
- Rekrytering
- Clinvest Headlands Llc
-
Kontakt:
- Telefonnummer: (417) 883-7889
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St Louis, Missouri, Förenta staterna, 63141
- Rekrytering
- Sundance Clinical Research
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Kontakt:
- Telefonnummer: (314) 567-3377
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89109
- Rekrytering
- Excel Clinical Research
-
Kontakt:
- Telefonnummer: (702) 680-1500
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Las Vegas, Nevada, Förenta staterna, 89119
- Rekrytering
- Redbird Research
-
Kontakt:
- Telefonnummer: (702) 577-2000
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Las Vegas, Nevada, Förenta staterna, 89102
- Rekrytering
- Ima Clinical Research - Las Vegas
-
Kontakt:
- Telefonnummer: (702) 527-7401
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Las Vegas, Nevada, Förenta staterna, 89118
- Rekrytering
- Wake Research Las Vegas Rainbow
-
Kontakt:
- Telefonnummer: (702) 893-8968
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Las Vegas, Nevada, Förenta staterna, 89119
- Rekrytering
- AMR Clinical - Las Vegas
-
Kontakt:
- Telefonnummer: (702) 529-0153
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North Las Vegas, Nevada, Förenta staterna, 89030
- Rekrytering
- Las Vegas Clinical Trials
-
Kontakt:
- Telefonnummer: (702) 637-3223
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Reno, Nevada, Förenta staterna, 89511
- Rekrytering
- Advanced Research Institute - Reno
-
Kontakt:
- Telefonnummer: (775) 502-1616
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87102
- Rekrytering
- Albuquerque Clinical Trials
-
Kontakt:
- Telefonnummer: (505) 224-7407
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New York
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Amherst, New York, Förenta staterna, 14226
- Rekrytering
- Dent Neuro Institute, Buffalo
-
Kontakt:
- Telefonnummer: (716) 250-2017
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Brooklyn, New York, Förenta staterna, 11235
- Rekrytering
- SPRI Clinical Trials, LLC
-
Kontakt:
- Telefonnummer: (646) 747-4060
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Commack, New York, Förenta staterna, 11725
- Rekrytering
- True North Neurology
-
Kontakt:
- Telefonnummer: (631) 364-9119
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Manlius, New York, Förenta staterna, 13104
- Rekrytering
- Central New York Clinical Research
-
Kontakt:
- Telefonnummer: (315) 682-3263
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New York, New York, Förenta staterna, 10017
- Rekrytering
- Fieve Clinical Research, Inc
-
Kontakt:
- Telefonnummer: (212) 772-3570
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Rochester, New York, Förenta staterna, 14609
- Rekrytering
- Rochester Clinical Research
-
Kontakt:
- Telefonnummer: (585) 288-0890
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Williamsville, New York, Förenta staterna, 14221
- Rekrytering
- 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, Förenta staterna, 28277
- Rekrytering
- Onsite Clinical Solutions
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Kontakt:
- Telefonnummer: (800) 785-3150
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Greensboro, North Carolina, Förenta staterna, 27405
- Rekrytering
- Headache Wellness Center
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Kontakt:
- Telefonnummer: (336) 574-8000
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Greensboro, North Carolina, Förenta staterna, 27405
- Rekrytering
- Guildford Neurologic Research Partners, LLC
-
Kontakt:
- Telefonnummer: (336) 516-9103
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Raleigh, North Carolina, Förenta staterna, 27607
- Rekrytering
- Eximia Research - NC, LLC
-
Kontakt:
- Telefonnummer: (919) 800-5154
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Shelby, North Carolina, Förenta staterna, 28150
- Rekrytering
- Carolina Research Center, Inc
-
Kontakt:
- Telefonnummer: (704) 487-5228
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Ohio
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Columbus, Ohio, Förenta staterna, 43228
- Rekrytering
- Hometown Research
-
Kontakt:
- Telefonnummer: (614) 362-3980
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Milford, Ohio, Förenta staterna, 45150
- Rekrytering
- Hometown Research
-
Kontakt:
- Telefonnummer: (513) 831-5900
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West Chester, Ohio, Förenta staterna, 45069
- Rekrytering
- CincyScience
-
Kontakt:
- Telefonnummer: (513) 646-4864
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Oklahoma
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Edmond, Oklahoma, Förenta staterna, 73034
- Rekrytering
- OK Clinical Research, LLC
-
Kontakt:
- Telefonnummer: (405) 285-6811
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Oklahoma City, Oklahoma, Förenta staterna, 73102
- Rekrytering
- Hightower Clinical
-
Kontakt:
- Telefonnummer: (405) 479-8331
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Tulsa, Oklahoma, Förenta staterna, 74133
- Rekrytering
- DelRicht Research
-
Kontakt:
- Telefonnummer: (918) 932-2276
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Yukon, Oklahoma, Förenta staterna, 73099
- Rekrytering
- Tekton Research, Inc.
-
Kontakt:
- Telefonnummer: (405) 281-3433
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Oregon
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Portland, Oregon, Förenta staterna, 97210
- Rekrytering
- Summit Research Network
-
Kontakt:
- Telefonnummer: (855) 367-8834
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Portland, Oregon, Förenta staterna, 97223
- Rekrytering
- Advanced Research Institute - Portland
-
Kontakt:
- Telefonnummer: (503) 610-0033
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Pennsylvania
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Allentown, Pennsylvania, Förenta staterna, 18103
- Rekrytering
- Lehigh Center For Clinical Research
-
Kontakt:
- Telefonnummer: (818) 578-4555
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Philadelphia, Pennsylvania, Förenta staterna, 19114
- Rekrytering
- Clinical Research Philadelphia
-
Kontakt:
- Telefonnummer: (215) 676-6696
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Pittsburgh, Pennsylvania, Förenta staterna, 15236
- Rekrytering
- Preferred Primary Care Physicians, Inc.
-
Kontakt:
- Telefonnummer: (412) 650-6155
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Scottdale, Pennsylvania, Förenta staterna, 15683
- Rekrytering
- Frontier Clinical Research, LLC
-
Kontakt:
- Telefonnummer: (724) 220-5281
-
Smithfield, Pennsylvania, Förenta staterna, 15478
- Rekrytering
- Frontier Clinical Research, LLC
-
Kontakt:
- Telefonnummer: (724) 569-8036
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South Carolina
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North Charleston, South Carolina, Förenta staterna, 29405
- Rekrytering
- Coastal Carolina Research Center
-
Kontakt:
- Telefonnummer: (843) 856-3784
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Tennessee
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Chattanooga, Tennessee, Förenta staterna, 37421
- Rekrytering
- WR-ClinSearch, LLC
-
Kontakt:
- Telefonnummer: (423) 698-4584
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Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- Clinical Research Associates, Inc.
-
Kontakt:
- Telefonnummer: (615) 329-0197
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Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- Access Clinical Trials, Inc
-
Kontakt:
- Telefonnummer: (615) 320-6076
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-
Texas
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Austin, Texas, Förenta staterna, 78731
- Rekrytering
- FutureSearch Trials of Neurology
-
Kontakt:
- Telefonnummer: (512) 380-9925
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Austin, Texas, Förenta staterna, 78745
- Rekrytering
- Tekton Research
-
Kontakt:
- Telefonnummer: (512) 859-3834
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Cypress, Texas, Förenta staterna, 77372
- Rekrytering
- APD Clinical Research
-
Kontakt:
- Telefonnummer: (281) 315-4986
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Cypress, Texas, Förenta staterna, 77429
- Rekrytering
- Horizon Clinical Research and Gill Neuroscience
-
Kontakt:
- Telefonnummer: (949) 491-0710
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Dallas, Texas, Förenta staterna, 75251
- Rekrytering
- FutureSearch Trials of Dallas, LP
-
Kontakt:
- Telefonnummer: (214) 361-7700
-
Houston, Texas, Förenta staterna, 77081
- Rekrytering
- DM Clinical Research
-
Kontakt:
- Telefonnummer: (346) 550-9559
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Houston, Texas, Förenta staterna, 77024
- Rekrytering
- Victorium Clinical Research
-
Kontakt:
- Telefonnummer: (832) 203-7026
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Lampasas, Texas, Förenta staterna, 76550
- Rekrytering
- GMG Clinical Research, LLC dba Radiance Clinical Research
-
Kontakt:
- Telefonnummer: (512) 556-4130
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Plano, Texas, Förenta staterna, 75093
- Rekrytering
- AIM Trials, LLC
-
Kontakt:
- Telefonnummer: (214) 856-2778
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Waxahachie, Texas, Förenta staterna, 75165
- Rekrytering
- ClinPoint Trials
-
Kontakt:
- Telefonnummer: (972) 937-1640
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Utah
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Bountiful, Utah, Förenta staterna, 84010
- Rekrytering
- Pantheon Clinical Research
-
Kontakt:
- Telefonnummer: (385) 281-0550
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Draper, Utah, Förenta staterna, 84020
- Rekrytering
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
-
Kontakt:
- Telefonnummer: 3511 (801) 365-1032
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Ogden, Utah, Förenta staterna, 84405
- Rekrytering
- Advanced Research Institute
-
Kontakt:
- Telefonnummer: (801) 409-2040
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Riverton, Utah, Förenta staterna, 84096
- Rekrytering
- Granger Medical Clinic
-
Kontakt:
- Telefonnummer: (801) 302-1769
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Salt Lake City, Utah, Förenta staterna, 84109
- Rekrytering
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Kontakt:
- Telefonnummer: 3315 (801) 486-3021
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Salt Lake City, Utah, Förenta staterna, 84121
- Rekrytering
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Kontakt:
- Telefonnummer: 3538 (801) 365-1032
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Virginia
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Newport News, Virginia, Förenta staterna, 23606
- Rekrytering
- Health Research of Hampton Roads, Inc. (HRHR)
-
Kontakt:
- Telefonnummer: (757) 591-8100
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Norfolk, Virginia, Förenta staterna, 23502
- Rekrytering
- AMR Clinical - Norfolk
-
Kontakt:
- Telefonnummer: (757) 614-1001
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-
Washington
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Seattle, Washington, Förenta staterna, 98104
- Rekrytering
- Seattle Clinical Research Center
-
Kontakt:
- Telefonnummer: (206) 522-3330
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West Virginia
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Morgantown, West Virginia, Förenta staterna, 26505
- Rekrytering
- Frontier Clinical Research
-
Kontakt:
- Telefonnummer: (304) 241-1648
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Wisconsin
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Kenosha, Wisconsin, Förenta staterna, 53144
- Rekrytering
- Clinical Investigation Specialists, Inc.
-
Kontakt:
- Telefonnummer: (847) 406-8080
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
1. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent. 2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements:
a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:
- A minimum of 12 months of spontaneous amenorrhea or
- A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level > 40 mIU/mL or
- At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.
Acceptable methods of birth control are:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).
- Intrauterine device (IUD);
- Intrauterine hormone-releasing system (IUS);
- Bilateral tubal occlusion;
- Vasectomized partner;
- Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;
- Male or female condom with or without spermicide;
- Cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).
5. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.
Exclusion Criteria:
Participants are excluded from the trial if any of the following criteria apply:
Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial.
Migraine history-related
- Has difficulty distinguishing his/her migraine attacks from tension-type headaches.
- Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.
- Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).
- Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.
- Was >50 years old at age of first migraine onset.
Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening.
Medical history related
- Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine [Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study].
- Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 2 months or suicidal behavior in the past 6 months.
- Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.
- Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.
- Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.
- Has a history of human immunodeficiency virus disease.
Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption or may otherwise alter the absorption of orally administered drugs (e.g. upper gastrointestinal dysmotility).
Laboratory, vital sign, and electrocardiogram related
- Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.
- Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of <30 mL/min/1.73 m2.
- Has a screening result for alanine aminotransferase or aspartate aminotransferase of >2.0 X upper limit of normal (ULN) or total bilirubin >1.5 X ULN at the Screening visit. Note: An isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range.
- Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) >450 ms for males and >470 ms for females at screening.
Has a mean value for triplicate seated systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood pressure is exclusionary on the first triplicate assessment at the Screening Visit, they may have one repeat triplicate blood pressure assessment at that visit after another rest of at least 10 minutes.
Medication use and substance abuse related
- Has known history of or suspected abuse of alcohol or recreational drugs at Screening.
- Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol [THC] or cannabidiol [CBD] within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior to screening.
Has a positive drug screen at screening. Note:
- If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the prescribing physician.
- If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatory documentation is obtained from the prescribing physician, and the stimulant medication in question is known to be detected as amphetamine on the drug screen being used.
Is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during study participation (detailed in the protocol). Note: Any use of the following within 8 weeks of the screening visit, or anticipated use at any point during study participation are exclusionary:
- Devices for the acute and/or preventative treatment of headache (migraine and/or other type of headache)
- Nerve blocks and/or trigger point injections for the acute and/or preventative treatment of headache (migraine and/or other type of headache).
- Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
- Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.
Has a history of non-narcotic analgesic intake ≥15 days per month for ≥3 months prior to screening.
Other
- Has known or suspected hypersensitivity to trial product(s) or related products.
- Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
- Has any surgery scheduled for the duration of the trial.
- Has a screening hemoglobin <11.0 g/dL (males) or <10.0 g/dL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia).
- Has previous participation in this trial. Participation is defined as signed informed consent.
- Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of screening or ever signed an informed consent for Study K-304 P004. Note: Patients may not be screened at more than one trial site for this study.
- Has any other disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.
- Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo
|
Administreras oralt
|
|
Experimentell: Elismetrep 10 mg
|
Administered orally
Andra namn:
|
|
Experimentell: Elismetrep 20 mg
|
Administered orally
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain freedom at 2 hours post-dose
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain relief at 2 hours post-dose
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: Up to 8 days post-dose
|
Up to 8 days post-dose
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2026
Primärt slutförande (Beräknad)
1 februari 2027
Avslutad studie (Beräknad)
1 februari 2027
Studieregistreringsdatum
Först inskickad
9 juni 2026
Först inskickad som uppfyllde QC-kriterierna
9 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- K-304 P003
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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