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

9. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

1800

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Arzneimittel: Placebo
Oral verabreicht
Experimental: Elismetrep 10 mg
Arzneimittel: Elismetrep
Administered orally
Andere Namen:
  • K-304
Experimental: Elismetrep 20 mg
Arzneimittel: Elismetrep
Administered orally
Andere Namen:
  • K-304

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain freedom at 2 hours post-dose
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain relief at 2 hours post-dose
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Up to 8 days post-dose
Up to 8 days post-dose

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Kallyope Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Februar 2027

Studienabschluss (Geschätzt)

1. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juni 2026

Zuerst gepostet (Tatsächlich)

12. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • K-304 P003

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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