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

June 9, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent. 2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements:

a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administered orally
Experimental: Elismetrep 10 mg
Drug: Elismetrep
Administered orally
Other Names:
  • K-304
Experimental: Elismetrep 20 mg
Drug: Elismetrep
Administered orally
Other Names:
  • K-304

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain freedom at 2 hours post-dose
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief at 2 hours post-dose
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: Up to 8 days post-dose
Up to 8 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kallyope Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-304 P003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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