Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine

9 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1800

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Portoryko
      • San Juan, Portoryko, 00907
        • Solace Clinical Research
        • Kontakt:
          • Numer telefonu: (787) 425-4881
  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35205
        • Central Research Associates, LLC (CRA) dba Flourish Research
        • Kontakt:
          • Numer telefonu: (205) 327-1077
      • Mobile, Alabama, Stany Zjednoczone, 36608
        • AMR Mobile
        • Kontakt:
          • Numer telefonu: (251) 901-2127
    • Arizona
      • Chandler, Arizona, Stany Zjednoczone, 85286
        • TrialSphere
        • Kontakt:
          • Numer telefonu: (623) 267-8314
    • Arkansas
      • Little Rock, Arkansas, Stany Zjednoczone, 72205
        • Arkansas Clinical Research
        • Kontakt:
          • Numer telefonu: (501) 480-5088
    • California
      • Colton, California, Stany Zjednoczone, 92324
        • Axiom Research, LLC
        • Kontakt:
          • Numer telefonu: (909) 824-2325
      • Culver City, California, Stany Zjednoczone, 90230
        • ProScience Research Group
        • Kontakt:
          • Numer telefonu: (424) 227-8127
      • Encino, California, Stany Zjednoczone, 91316
        • Leading Edge Research LA, LLC
        • Kontakt:
          • Numer telefonu: (818) 578-4555
      • Irvine, California, Stany Zjednoczone, 92604
        • Axiom Research, Orange County
        • Kontakt:
          • Numer telefonu: (909) 824-2325
      • Los Angeles, California, Stany Zjednoczone, 90048
        • Clinical Research Institute
        • Kontakt:
          • Numer telefonu: (323) 879-9999
      • Los Angeles, California, Stany Zjednoczone, 90017
        • Downtown L.A. Research Center, Inc.
        • Kontakt:
          • Numer telefonu: (213) 261-3680
      • Mission Viejo, California, Stany Zjednoczone, 92691
        • M3 Wake Research - Mission Mental Health (WR-MMH)
        • Kontakt:
          • Numer telefonu: (949) 752-7910
      • Oceanside, California, Stany Zjednoczone, 92056
        • Excell Research
        • Kontakt:
          • Numer telefonu: (760) 758-2222
      • Pomona, California, Stany Zjednoczone, 91767
        • The Neurology Group
        • Kontakt:
          • Numer telefonu: 603 (909) 982-2719
      • Pomona, California, Stany Zjednoczone, 91767
        • Empire Clinical Research
        • Kontakt:
          • Numer telefonu: (909) 981-5321
      • Riverside, California, Stany Zjednoczone, 92503
        • Artemis Institute for Clinical Research
        • Kontakt:
          • Numer telefonu: (855) 367-8834
      • San Diego, California, Stany Zjednoczone, 92120
        • Acclaim Clinical Research
        • Kontakt:
          • Numer telefonu: (855) 367-8834
      • Sherman Oaks, California, Stany Zjednoczone, 91403
        • CenExel Sherman Oaks CA (California Neuroscience Research)
        • Kontakt:
          • Numer telefonu: (818) 990-2671
      • Spring Valley, California, Stany Zjednoczone, 91978
        • Encompass Clinical Research
        • Kontakt:
          • Numer telefonu: (619) 660-9068
      • Walnut Creek, California, Stany Zjednoczone, 94598
        • Diablo Clinical Research
        • Kontakt:
          • Numer telefonu: (925) 930-7267
      • Walnut Creek, California, Stany Zjednoczone, 94596
        • Sunwise Clinical Research
        • Kontakt:
          • Numer telefonu: (925) 298-5147
      • West Covina, California, Stany Zjednoczone, 91790
        • Kinetic Clinical Research
        • Kontakt:
          • Numer telefonu: (657) 230-7120
      • West Hills, California, Stany Zjednoczone, 91307
        • Focus Clinical Research
        • Kontakt:
          • Numer telefonu: (818) 253-8966
    • Colorado
      • Centennial, Colorado, Stany Zjednoczone, 80112
        • IMMUNOe Research Centers
        • Kontakt:
          • Numer telefonu: (303) 771-9000
      • Colorado Springs, Colorado, Stany Zjednoczone, 80910
        • MCB Clinical Research Centers
        • Kontakt:
          • Numer telefonu: (719) 634-6576
      • Fort Collins, Colorado, Stany Zjednoczone, 80528
        • Advanced Neurosciences Research
        • Kontakt:
          • Numer telefonu: (970) 226-6111
    • Connecticut
      • Waterbury, Connecticut, Stany Zjednoczone, 06708
        • Chase Medical Research, LLC
        • Kontakt:
          • Numer telefonu: (203) 419-4404
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30329
        • DelRicht Research
        • Kontakt:
          • Numer telefonu: (770) 417-4454
      • Marietta, Georgia, Stany Zjednoczone, 30060
        • Drug Studies America
        • Kontakt:
          • Numer telefonu: (678) 581-5252
      • Stockbridge, Georgia, Stany Zjednoczone, 30281
        • Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
        • Kontakt:
          • Numer telefonu: (770) 626-0177
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60607
        • Cedar Crosse Research Center
        • Kontakt:
          • Numer telefonu: (312) 431-6780
      • Chicago, Illinois, Stany Zjednoczone, 60657
        • Chicago Headache Center & Research Institute
        • Kontakt:
          • Numer telefonu: (773) 935-1000
      • Flossmoor, Illinois, Stany Zjednoczone, 60477
        • Healthcare Research Network II, LLC
        • Kontakt:
          • Numer telefonu: (708) 388-2245
      • Naperville, Illinois, Stany Zjednoczone, 60563
        • Chicago Headache Center & Research Institute
        • Kontakt:
          • Numer telefonu: (415) 397-0700
    • Iowa
      • West Des Moines, Iowa, Stany Zjednoczone, 50265
        • Integrated Clinical Trials Solution
        • Kontakt:
          • Numer telefonu: (515) 223-2300
    • Kansas
      • Overland Park, Kansas, Stany Zjednoczone, 66212
        • Collective Medical Research
        • Kontakt:
          • Numer telefonu: (913) 381-7180
      • Overland Park, Kansas, Stany Zjednoczone, 66214
        • Clinical Associates Midwest, LLC
        • Kontakt:
          • Numer telefonu: (913) 359-5699
      • Wichita, Kansas, Stany Zjednoczone, 67207
        • Heartland Research Associates, LLC - An AMR Company
        • Kontakt:
          • Numer telefonu: (316) 689-6635
    • Kentucky
      • Bardstown, Kentucky, Stany Zjednoczone, 40004
        • Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
        • Kontakt:
          • Numer telefonu: (502) 349-1569
      • Lexington, Kentucky, Stany Zjednoczone, 40509
        • AMR Clinical - Lexington
        • Kontakt:
          • Numer telefonu: (859) 264-8999
      • Lexington, Kentucky, Stany Zjednoczone, 45212
        • CTI Clinical Research Center
        • Kontakt:
          • Numer telefonu: (513) 721-3868
      • Louisville, Kentucky, Stany Zjednoczone, 40213
        • Monroe Biomedical Research (former L-MARC Research Center)
        • Kontakt:
          • Numer telefonu: (502) 305-1010
    • Louisiana
      • Chalmette, Louisiana, Stany Zjednoczone, 70043
        • Crescent City Headache & Neurology Center
        • Kontakt:
          • Numer telefonu: (504) 418-6040
      • New Orleans, Louisiana, Stany Zjednoczone, 70115
        • DelRicht Research
        • Kontakt:
          • Numer telefonu: (504) 336-2667
    • Maryland
      • Pikesville, Maryland, Stany Zjednoczone, 21208
        • Headlands Research - Pharmasite
        • Kontakt:
          • Numer telefonu: (410) 602-1440
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02131
        • Boston Clinical Trials - Alcanza
        • Kontakt:
          • Numer telefonu: (843) 856-3784
      • Waltham, Massachusetts, Stany Zjednoczone, 02451
        • MedVadis Research Corporation, LLC
        • Kontakt:
          • Numer telefonu: (781) 373-2940
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48104
        • Michigan Headache Pain & Neurological Institute
        • Kontakt:
          • Numer telefonu: Option 4 (734) 677-6000
    • Minnesota
      • Burnsville, Minnesota, Stany Zjednoczone, 55337
        • Minneapolis Clinic of Neurology
        • Kontakt:
          • Numer telefonu: (763) 302-4162
      • Minneapolis, Minnesota, Stany Zjednoczone, 55402
        • Clinical Research Institute
        • Kontakt:
          • Numer telefonu: 5 (612) 333-2200
    • Mississippi
      • Gulfport, Mississippi, Stany Zjednoczone, 39503
        • DelRicht Research
        • Kontakt:
          • Numer telefonu: (228) 588-8268
      • Ridgeland, Mississippi, Stany Zjednoczone, 39157
        • Proven Endpoints
        • Kontakt:
          • Numer telefonu: (601) 790-1811
    • Missouri
      • City of Saint Peters, Missouri, Stany Zjednoczone, 63303
        • StudyMetrix Research
        • Kontakt:
          • Numer telefonu: (636) 387-5100
      • Hazelwood, Missouri, Stany Zjednoczone, 63042
        • Healthcare Research Network
        • Kontakt:
          • Numer telefonu: (314) 972-9600
      • Kansas City, Missouri, Stany Zjednoczone, 64114
        • AMR Clinical - Kansas City
        • Kontakt:
          • Numer telefonu: (816) 643-4153
      • Springfield, Missouri, Stany Zjednoczone, 65807
        • Clinvest Headlands LLC
        • Kontakt:
          • Numer telefonu: (417) 883-7889
      • St Louis, Missouri, Stany Zjednoczone, 63141
        • Sundance Clinical Research
        • Kontakt:
          • Numer telefonu: (314) 567-3377
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89109
        • Excel Clinical Research
        • Kontakt:
          • Numer telefonu: (702) 680-1500
      • Las Vegas, Nevada, Stany Zjednoczone, 89119
        • Redbird Research
        • Kontakt:
          • Numer telefonu: (702) 577-2000
      • Las Vegas, Nevada, Stany Zjednoczone, 89102
        • IMA Clinical Research - Las Vegas
        • Kontakt:
          • Numer telefonu: (702) 527-7401
      • Las Vegas, Nevada, Stany Zjednoczone, 89119
        • AMR Clinical - Las Vegas
        • Kontakt:
          • Numer telefonu: (702) 529-0153
      • Las Vegas, Nevada, Stany Zjednoczone, 89118
        • Wake Research Las Vegas Rainbow
        • Kontakt:
          • Numer telefonu: (702) 893-8968
      • North Las Vegas, Nevada, Stany Zjednoczone, 89030
        • Las Vegas Clinical Trials
        • Kontakt:
          • Numer telefonu: (702) 637-3223
      • Reno, Nevada, Stany Zjednoczone, 89511
        • Advanced Research Institute - Reno
        • Kontakt:
          • Numer telefonu: (775) 502-1616
    • New Mexico
      • Albuquerque, New Mexico, Stany Zjednoczone, 87102
        • Albuquerque Clinical Trials
        • Kontakt:
          • Numer telefonu: (505) 224-7407
    • New York
      • Amherst, New York, Stany Zjednoczone, 14226
        • Dent Neuro Institute, Buffalo
        • Kontakt:
          • Numer telefonu: (716) 250-2017
      • Brooklyn, New York, Stany Zjednoczone, 11235
        • SPRI Clinical Trials, LLC
        • Kontakt:
          • Numer telefonu: (646) 747-4060
      • Commack, New York, Stany Zjednoczone, 11725
        • True North Neurology
        • Kontakt:
          • Numer telefonu: (631) 364-9119
      • Manlius, New York, Stany Zjednoczone, 13104
        • Central New York Clinical Research
        • Kontakt:
          • Numer telefonu: (315) 682-3263
      • New York, New York, Stany Zjednoczone, 10017
        • Fieve Clinical Research, Inc
        • Kontakt:
          • Numer telefonu: (212) 772-3570
      • Rochester, New York, Stany Zjednoczone, 14609
        • Rochester Clinical Research
        • Kontakt:
          • Numer telefonu: (585) 288-0890
      • Williamsville, New York, Stany Zjednoczone, 14221
        • Upstate Clinical Research Associates
        • Kontakt:
          • Numer telefonu: (716) 626-6320
    • North Carolina
      • Charlotte, North Carolina, Stany Zjednoczone, 28277
        • OnSite Clinical Solutions
        • Kontakt:
          • Numer telefonu: (800) 785-3150
      • Greensboro, North Carolina, Stany Zjednoczone, 27405
        • Headache Wellness Center
        • Kontakt:
          • Numer telefonu: (336) 574-8000
      • Greensboro, North Carolina, Stany Zjednoczone, 27405
        • Guildford Neurologic Research Partners, LLC
        • Kontakt:
          • Numer telefonu: (336) 516-9103
      • Raleigh, North Carolina, Stany Zjednoczone, 27607
        • Eximia Research - NC, LLC
        • Kontakt:
          • Numer telefonu: (919) 800-5154
      • Shelby, North Carolina, Stany Zjednoczone, 28150
        • Carolina Research Center, Inc
        • Kontakt:
          • Numer telefonu: (704) 487-5228
    • Ohio
      • Columbus, Ohio, Stany Zjednoczone, 43228
        • Hometown Research
        • Kontakt:
          • Numer telefonu: (614) 362-3980
      • Huber Heights, Ohio, Stany Zjednoczone, 45424
        • Hometown Research
        • Kontakt:
          • Numer telefonu: (937) 912-4364
      • Milford, Ohio, Stany Zjednoczone, 45150
        • Hometown Research
        • Kontakt:
          • Numer telefonu: (513) 831-5900
      • West Chester, Ohio, Stany Zjednoczone, 45069
        • CincyScience
        • Kontakt:
          • Numer telefonu: (513) 646-4864
    • Oklahoma
      • Edmond, Oklahoma, Stany Zjednoczone, 73034
        • OK Clinical Research, LLC
        • Kontakt:
          • Numer telefonu: (405) 285-6811
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73102
        • Hightower Clinical
        • Kontakt:
          • Numer telefonu: (405) 479-8331
      • Tulsa, Oklahoma, Stany Zjednoczone, 74133
        • DelRicht Research
        • Kontakt:
          • Numer telefonu: (918) 932-2276
      • Yukon, Oklahoma, Stany Zjednoczone, 73099
        • Tekton Research, Inc.
        • Kontakt:
          • Numer telefonu: (405) 281-3433
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97210
        • Summit Research Network
        • Kontakt:
          • Numer telefonu: (855) 367-8834
      • Portland, Oregon, Stany Zjednoczone, 97223
        • Advanced Research Institute - Portland
        • Kontakt:
          • Numer telefonu: (503) 610-0033
    • Pennsylvania
      • Allentown, Pennsylvania, Stany Zjednoczone, 18103
        • Lehigh Center for Clinical Research
        • Kontakt:
          • Numer telefonu: (818) 578-4555
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19114
        • Clinical Research Philadelphia
        • Kontakt:
          • Numer telefonu: (215) 676-6696
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15236
        • Preferred Primary Care Physicians, Inc.
        • Kontakt:
          • Numer telefonu: (412) 650-6155
      • Scottdale, Pennsylvania, Stany Zjednoczone, 15683
        • Frontier Clinical Research, LLC
        • Kontakt:
          • Numer telefonu: (724) 220-5281
      • Smithfield, Pennsylvania, Stany Zjednoczone, 15478
        • Frontier Clinical Research, LLC
        • Kontakt:
          • Numer telefonu: (724) 569-8036
    • South Carolina
      • North Charleston, South Carolina, Stany Zjednoczone, 29405
        • Coastal Carolina Research Center
        • Kontakt:
          • Numer telefonu: (843) 856-3784
    • Tennessee
      • Chattanooga, Tennessee, Stany Zjednoczone, 37421
        • WR-ClinSearch, LLC
        • Kontakt:
          • Numer telefonu: (423) 698-4584
      • Nashville, Tennessee, Stany Zjednoczone, 37203
        • Access Clinical Trials, Inc
        • Kontakt:
          • Numer telefonu: (615) 320-6076
      • Nashville, Tennessee, Stany Zjednoczone, 37203
        • Clinical Research Associates, Inc.
        • Kontakt:
          • Numer telefonu: (615) 329-0197
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78731
        • FutureSearch Trials of Neurology
        • Kontakt:
          • Numer telefonu: (512) 380-9925
      • Austin, Texas, Stany Zjednoczone, 78745
        • Tekton Research
        • Kontakt:
          • Numer telefonu: (512) 859-3834
      • Cypress, Texas, Stany Zjednoczone, 77372
        • APD Clinical Research
        • Kontakt:
          • Numer telefonu: (281) 315-4986
      • Cypress, Texas, Stany Zjednoczone, 77429
        • Horizon Clinical Research and Gill Neuroscience
        • Kontakt:
          • Numer telefonu: (949) 491-0710
      • Dallas, Texas, Stany Zjednoczone, 75243
        • Relaro Medical Trials, LLC
        • Kontakt:
          • Numer telefonu: (469) 730-3282
      • Dallas, Texas, Stany Zjednoczone, 75251
        • FutureSearch Trials of Dallas, LP
        • Kontakt:
          • Numer telefonu: (214) 361-7700
      • Fort Worth, Texas, Stany Zjednoczone, 76104
        • Helios CR, Inc. - Fort Worth
        • Kontakt:
          • Numer telefonu: (817) 348-0228
      • Houston, Texas, Stany Zjednoczone, 77024
        • Victorium Clinical Research
        • Kontakt:
          • Numer telefonu: (832) 203-7026
      • Houston, Texas, Stany Zjednoczone, 77081
        • DM Clinical Research
        • Kontakt:
          • Numer telefonu: (346) 550-9559
      • Keller, Texas, Stany Zjednoczone, 76248
        • Helios CR, Inc. - Keller
        • Kontakt:
          • Numer telefonu: (682) 774-8013
      • Lampasas, Texas, Stany Zjednoczone, 76550
        • GMG Clinical Research, LLC dba Radiance Clinical Research
        • Kontakt:
          • Numer telefonu: (512) 556-4130
      • Plano, Texas, Stany Zjednoczone, 75093
        • Aim Trials, LLC
        • Kontakt:
          • Numer telefonu: (214) 856-2778
      • Waxahachie, Texas, Stany Zjednoczone, 75165
        • Clinpoint Trials
        • Kontakt:
          • Numer telefonu: (972) 937-1640
    • Utah
      • Bountiful, Utah, Stany Zjednoczone, 84010
        • Pantheon Clinical Research
        • Kontakt:
          • Numer telefonu: (385) 281-0550
      • Draper, Utah, Stany Zjednoczone, 84020
        • J. Lewis Research, Inc. / Foothill Family Clinic Draper
        • Kontakt:
          • Numer telefonu: 3511 (801) 365-1032
      • Ogden, Utah, Stany Zjednoczone, 84405
        • Advanced Research Institute
        • Kontakt:
          • Numer telefonu: (801) 409-2040
      • Riverton, Utah, Stany Zjednoczone, 84096
        • Granger Medical Clinic
        • Kontakt:
          • Numer telefonu: (801) 302-1769
      • Salt Lake City, Utah, Stany Zjednoczone, 84109
        • J. Lewis Research, Inc. / Foothill Family Clinic
        • Kontakt:
          • Numer telefonu: 3315 (801) 486-3021
      • Salt Lake City, Utah, Stany Zjednoczone, 84121
        • J. Lewis Research, Inc. / Foothill Family Clinic
        • Kontakt:
          • Numer telefonu: 3538 (801) 365-1032
    • Virginia
      • Newport News, Virginia, Stany Zjednoczone, 23606
        • Health Research of Hampton Roads, Inc. (HRHR)
        • Kontakt:
          • Numer telefonu: (757) 591-8100
      • Norfolk, Virginia, Stany Zjednoczone, 23502
        • AMR Clinical - Norfolk
        • Kontakt:
          • Numer telefonu: (757) 614-1001
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98104
        • Seattle Clinical Research Center
        • Kontakt:
          • Numer telefonu: (206) 522-3330
    • West Virginia
      • Morgantown, West Virginia, Stany Zjednoczone, 26505
        • Frontier Clinical Research
        • Kontakt:
          • Numer telefonu: (304) 241-1648
    • Wisconsin
      • Kenosha, Wisconsin, Stany Zjednoczone, 53144
        • Clinical Investigation Specialists, Inc.
        • Kontakt:
          • Numer telefonu: (847) 406-8080

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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:

  1. A minimum of 12 months of spontaneous amenorrhea or
  2. A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level > 40 mIU/mL or
  3. 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:

  1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
  2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).
  3. Intrauterine device (IUD);
  4. Intrauterine hormone-releasing system (IUS);
  5. Bilateral tubal occlusion;
  6. Vasectomized partner;
  7. Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;
  8. Male or female condom with or without spermicide;
  9. 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:

  1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial.

    Migraine history-related

  2. Has difficulty distinguishing his/her migraine attacks from tension-type headaches.
  3. Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.
  4. 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).
  5. Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.
  6. Was >50 years old at age of first migraine onset.

  7. 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

  8. 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].
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. Has a history of human immunodeficiency virus disease.

  14. 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

  15. Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.
  16. 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.
  17. 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.
  18. 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.

  19. 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

  20. Has known history of or suspected abuse of alcohol or recreational drugs at Screening.
  21. 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.

  22. Has a positive drug screen at screening. Note:

    1. 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.
    2. 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.
  23. 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).
  24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
  25. Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.

  26. Has a history of non-narcotic analgesic intake ≥15 days per month for

    • 3 months prior to screening.

    Other

  27. Has known or suspected hypersensitivity to trial product(s) or related products.
  28. 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.
  29. Has any surgery scheduled for the duration of the trial.
  30. 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).
  31. Has previous participation in this trial. Participation is defined as signed informed consent.
  32. 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.
  33. 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.
  34. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Lek: Placebo
Podawany doustnie
Eksperymentalny: Elismetrep 10 mg
Lek: Elismetrep
Administered orally
Inne nazwy:
  • K-304
Eksperymentalny: Elismetrep 20 mg
Lek: Elismetrep
Administered orally
Inne nazwy:
  • K-304

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Pain freedom at 2 hours post-dose
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pain relief at 2 hours post-dose
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Up to 8 days post-dose
Up to 8 days post-dose

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Kallyope Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 lutego 2027

Ukończenie studiów (Szacowany)

1 lutego 2027

Daty rejestracji na studia

Pierwszy przesłany

9 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

12 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • K-304 P003

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Placebo

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Australia

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj