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

October 30, 2026 updated by: TriGemX Bio, 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 safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

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

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Not yet recruiting
        • Sun City Clinical Research
        • Contact:
      • Phoenix, Arizona, United States, 85006
      • Phoenix, Arizona, United States, 85012
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Not yet recruiting
        • Preferred Research Partners, Inc.
        • Contact:
    • California
      • Canoga Park, California, United States, 91304
        • Recruiting
        • Alliance Research Institute, Canoga Park
        • Contact:
      • Chula Vista, California, United States, 91911
      • Fountain Valley, California, United States, 92708
        • Not yet recruiting
        • Ark Clinical Research, Fountain Valley
        • Contact:
      • Fullerton, California, United States, 92835
        • Recruiting
        • Neurology Center of North Orange County
        • Contact:
      • Glendale, California, United States, 91206
      • Long Beach, California, United States, 90806
      • Long Beach, California, United States, 90807
        • Recruiting
        • Accellacare - Long Beach
        • Contact:
      • Lynwood, California, United States, 90262
        • Not yet recruiting
        • Alliance Research Institute, Lynwood
        • Contact:
      • Northridge, California, United States, 91325
      • Pasadena, California, United States, 91101
        • Not yet recruiting
        • Pasadena Clinical Trials
        • Contact:
      • Redding, California, United States, 96001
        • Not yet recruiting
        • Paradigm Clinical Research Centers, LLC
        • Contact:
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92108
      • San Francisco, California, United States, 94102
        • Recruiting
        • Optimus Medical Group
        • Contact:
      • Santa Ana, California, United States, 92703
      • Van Nuys, California, United States, 91606
        • Not yet recruiting
        • Velocity Clinical Research, Van Nuys
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Paradigm Clinical Research Centers, LLC; Aurora
        • Contact:
      • Denver, Colorado, United States, 80246
    • Connecticut
      • Stamford, Connecticut, United States, 06905-1206
        • Not yet recruiting
        • Ki Health Partners, LLC
        • Contact:
    • Florida
      • Hallandale, Florida, United States, 33009
      • Lakeland, Florida, United States, 33805
      • Miami, Florida, United States, 33155
      • Ocoee, Florida, United States, 34761
      • Orlando, Florida, United States, 32819
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Cenexel Tampa FL
        • Contact:
      • West Palm Beach, Florida, United States, 33407
        • Not yet recruiting
        • Premiere Research Institute at Palm Beach Neurology
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Clinical Integrative Research Center of Atlanta
        • Contact:
      • Norcross, Georgia, United States, 30092
      • Savannah, Georgia, United States, 31406
    • Idaho
      • Boise, Idaho, United States, 83709
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Recruiting
        • Clinical Investigation Specialists, Inc.
        • Contact:
      • Skokie, Illinois, United States, 60077
        • Not yet recruiting
        • Evanston Premier Healthcare Research, LLC
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46254
      • Merrillville, Indiana, United States, 46410
    • Iowa
      • Ames, Iowa, United States, 50010
      • Sioux City, Iowa, United States, 51106
        • Not yet recruiting
        • Velocity Clinical Research, Sioux City
        • Contact:
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Not yet recruiting
        • NECCR PrimaCare Research, LLC
        • Contact:
      • Foxborough, Massachusetts, United States, 02035
        • Recruiting
        • Neurology Center of New England P.C.
        • Contact:
    • Montana
      • Missoula, Montana, United States, 59808
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Not yet recruiting
        • Velocity Clinical Research, Norfolk
        • Contact:
      • Omaha, Nebraska, United States, 68114
        • Not yet recruiting
        • Quality Clinical Research, Inc.
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Not yet recruiting
        • Oasis Clinical Research
        • Contact:
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Not yet recruiting
        • Bio Behavioral Health
        • Contact:
          • Ashok Patel
          • Phone Number: 732-244-2299
          • Email: ap@bbhnj.com
    • North Carolina
      • Cary, North Carolina, United States, 27518
      • Morehead City, North Carolina, United States, 28557
      • Raleigh, North Carolina, United States, 27609
        • Not yet recruiting
        • Accellacare - Raleigh (Raleigh Medical Group, P.A.)
        • Contact:
      • Wilmington, North Carolina, United States, 28401
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58104
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Recruiting
        • Velocity Clinical Research, Cleveland
        • Contact:
      • Blue Ash, Ohio, United States, 45242
        • Not yet recruiting
        • Velocity Clinical Research, Cincinnati, Blue Ash
        • Contact:
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Headache Center of Hope
        • Contact:
      • Columbus, Ohio, United States, 43213
    • Rhode Island
      • Providence, Rhode Island, United States, 02818
        • Recruiting
        • Velocity Clinical Research, Providence
        • Contact:
    • South Carolina
      • Anderson, South Carolina, United States, 29621
      • Gaffney, South Carolina, United States, 29340
        • Not yet recruiting
        • Velocity Clinical Research, Gaffney
        • Contact:
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Central Texas Clinical Research
        • Contact:
      • Beaumont, Texas, United States, 77702
        • Not yet recruiting
        • Gadolin Research, LLC
        • Contact:
      • Dallas, Texas, United States, 75230
      • DeSoto, Texas, United States, 75115
        • Not yet recruiting
        • Epic Medical Research - DeSoto
        • Contact:
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Newco 3A Researh LLC, DBA 3A Research
        • Contact:
      • Lake Jackson, Texas, United States, 77566
      • San Antonio, Texas, United States, 78240
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Clinical Trials of Texas, LLC, A Flourish Research Site
        • Contact:
      • Sugar Land, Texas, United States, 77479
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research, Tomball
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Not yet recruiting
        • Wasatch Clinical Research, LLC
        • Contact:
      • Salt Lake City, Utah, United States, 84124
        • Recruiting
        • Highland Clinical Research
        • Contact:

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 as documented in the patient's medical records from his/her treating physician or with pharmacy records confirming use of a migraine-specific medication (e.g. triptan, gepant, ditan) for > 1 year, and confirmed by the investigator. 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 subject'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;
  10. A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods). * Abstinence can be used as the sole method of contraception if it is in line with the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.

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:

Patients 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 study. Note: Female participants of child-bearing potential must have a negative serum pregnancy test (β-human chorionic gonadotropin) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.

    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 or treatments (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 P003. 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 subject'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. Note: Rescreening/retesting is not permitted unless specified above.

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
Experimental: Elismetrep 10 mg

Participants received a single dose of elismetrep 10 mg
Drug: Elismetrep

Administered orally

Other Names:
  • K-304
Experimental: Elismetrep 20 mg

Participants received a single dose of elismetrep 20 mg
Drug: Elismetrep

Administered orally

Other Names:
  • K-304
Placebo Comparator: Placebo

Participants received a single dose of placebo
Drug: Placebo

Administered orally

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 subjects who 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 subjects who 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
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
Pain relief at 2 hours post-dose
Time Frame: Two hours post-dose

Percentage of subjects who 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 24 hours post-dose
Time Frame: From 2 to 24 hours post-dose

Percentage of subjects who 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 freedom from 2 to 48 hours post-dose
Time Frame: From 2 to 48 hours post-dose

Percentage of subjects who 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 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 subjects who 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
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
Freedom from functional disability at 2 hours post-dose
Time Frame: Two hours post-dose

Percentage of subjects who self-report as being able to function normally on the functional disability scale in the subset of subjects who 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
Proportion requiring rescue medication within 24 hours post-dose
Time Frame: Within 24 hours post-dose

Percentage of subjects 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 subjects who report the absence of photophobia at 2 hours post-dose in the subset of subjects who 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 subjects who report the absence of phonophobia at 2 hours post-dose in the subset of subjects who 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 subjects who report the absence of nausea at 2 hours post-dose in the subset of subjects who reported the presence of nausea at baseline.
Two hours post-dose
Pain relapse from 2 to 48 hours post-dose
Time Frame: From 2 to 48 hours post-dose

Percentage of subjects who 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

Collaborators and Investigators

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

Sponsor

TriGemX Bio, 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 (Actual)

October 2, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 7, 2026

First Submitted That Met QC Criteria

September 7, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)

November 2, 2026

Last Update Submitted That Met QC Criteria

October 30, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-304 P004

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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