AzTrials
AzTrials

MigrainePhase 3NCT07645924

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

A Phase 3 study testing Elismetrep in people with Migraine, run by TriGemX Bio, Inc. at 113 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine
What is being tested?
Elismetrep
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,800 participants
Where
113 sitesUnited States
Study dates
1 Jul 2026to Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:
  • A minimum of 12 months of spontaneous amenorrhea or
  • A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level > 40 mIU/mL or
  • At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.
  • Acceptable methods of birth control are:
Show all 16Show fewer
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).
  • Intrauterine device (IUD);
  • Intrauterine hormone-releasing system (IUS);
  • Bilateral tubal occlusion;
  • Vasectomized partner;
  • Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;
  • Male or female condom with or without spermicide;
  • Cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).
  • 5. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.

Who cannot join

  • Participants are excluded from the trial if any of the following criteria apply:
  • Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial.
  • Migraine history-related
  • Has difficulty distinguishing his/her migraine attacks from tension-type headaches.
  • Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.
  • Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).
Show all 44Show fewer
  • Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.
  • Was >50 years old at age of first migraine onset.
  • Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening.
  • Medical history related
  • Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine [Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study].
  • Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 2 months or suicidal behavior in the past 6 months.
  • Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.
  • Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.
  • Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.
  • Has a history of human immunodeficiency virus disease.
  • Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption or may otherwise alter the absorption of orally administered drugs (e.g. upper gastrointestinal dysmotility).
  • Laboratory, vital sign, and electrocardiogram related
  • Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.
  • Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of <30 mL/min/1.73 m2.
  • Has a screening result for alanine aminotransferase or aspartate aminotransferase of >2.0 X upper limit of normal (ULN) or total bilirubin >1.5 X ULN at the Screening visit. Note: An isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range.
  • Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) >450 ms for males and >470 ms for females at screening.
  • Has a mean value for triplicate seated systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood pressure is exclusionary on the first triplicate assessment at the Screening Visit, they may have one repeat triplicate blood pressure assessment at that visit after another rest of at least 10 minutes.
  • Medication use and substance abuse related
  • Has known history of or suspected abuse of alcohol or recreational drugs at Screening.
  • Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol [THC] or cannabidiol [CBD] within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior to screening.
  • Has a positive drug screen at screening. Note:
  • If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the prescribing physician.
  • If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatory documentation is obtained from the prescribing physician, and the stimulant medication in question is known to be detected as amphetamine on the drug screen being used.
  • Is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during study participation (detailed in the protocol). Note: Any use of the following within 8 weeks of the screening visit, or anticipated use at any point during study participation are exclusionary:
  • Devices for the acute and/or preventative treatment of headache (migraine and/or other type of headache)
  • Nerve blocks and/or trigger point injections for the acute and/or preventative treatment of headache (migraine and/or other type of headache).
  • Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
  • Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.
  • Has a history of non-narcotic analgesic intake ≥15 days per month for ≥3 months prior to screening.
  • Other
  • Has known or suspected hypersensitivity to trial product(s) or related products.
  • Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
  • Has any surgery scheduled for the duration of the trial.
  • Has a screening hemoglobin <11.0 g/dL (males) or <10.0 g/dL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia).
  • Has previous participation in this trial. Participation is defined as signed informed consent.
  • Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of screening or ever signed an informed consent for Study K-304 P004. Note: Patients may not be screened at more than one trial site for this study.
  • Has any other disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.
  • Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.

Trial locations and contacts

113 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Annemarie Vance contact

917-336-3654

annemarie@kallyope.com

113 sites in 1 country

United States113 sites, 113 recruiting

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

    (505) 224-7407

    Recruiting

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18103

    (818) 578-4555

    Recruiting

  • Dent Neuro Institute, Buffalo

    Amherst, New York, 14226

    (716) 250-2017

    Recruiting

  • Michigan Headache Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

    (734) 677-6000 ext. Option 4

    Recruiting

  • DelRicht Research

    Atlanta, Georgia, 30329

    (770) 417-4454

    Recruiting

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

    (512) 380-9925

    Recruiting

  • Tekton Research

    Austin, Texas, 78745

    (512) 859-3834

    Recruiting

  • Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)

    Bardstown, Kentucky, 40004

    (502) 349-1569

    Recruiting

  • Central Research Associates, LLC (CRA) dba Flourish Research

    Birmingham, Alabama, 35205

    (205) 327-1077

    Recruiting

  • Boston Clinical Trials - Alcanza

    Boston, Massachusetts, 02131

    (843) 856-3784

    Recruiting

  • Pantheon Clinical Research

    Bountiful, Utah, 84010

    (385) 281-0550

    Recruiting

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

    (646) 747-4060

    Recruiting

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112

    (303) 771-9000

    Recruiting

  • Crescent City Headache & Neurology Center

    Chalmette, Louisiana, 70043

    (504) 418-6040

    Recruiting

  • TrialSphere

    Chandler, Arizona, 85286

    (623) 267-8314

    Recruiting

  • OnSite Clinical Solutions

    Charlotte, North Carolina, 28277

    (800) 785-3150

    Recruiting

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

    (423) 698-4584

    Recruiting

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

    (312) 431-6780

    Recruiting

  • Chicago Headache Center & Research Institute

    Chicago, Illinois, 60657

    (773) 935-1000

    Recruiting

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

    (636) 387-5100

    Recruiting

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910

    (719) 634-6576

    Recruiting

  • Axiom Research, LLC

    Colton, California, 92324

    (909) 824-2325

    Recruiting

  • Hometown Research

    Columbus, Ohio, 43228

    (614) 362-3980

    Recruiting

  • True North Neurology

    Commack, New York, 11725

    (631) 364-9119

    Recruiting

  • ProScience Research Group

    Culver City, California, 90230

    (424) 227-8127

    Recruiting

  • APD Clinical Research

    Cypress, Texas, 77372

    (281) 315-4986

    Recruiting

  • Horizon Clinical Research and Gill Neuroscience

    Cypress, Texas, 77429

    (949) 491-0710

    Recruiting

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75251

    (214) 361-7700

    Recruiting

  • J. Lewis Research, Inc. / Foothill Family Clinic Draper

    Draper, Utah, 84020

    (801) 365-1032 ext. 3511

    Recruiting

  • OK Clinical Research, LLC

    Edmond, Oklahoma, 73034

    (405) 285-6811

    Recruiting

  • Leading Edge Research LA, LLC

    Encino, California, 91316

    (818) 578-4555

    Recruiting

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60477

    (708) 388-2245

    Recruiting

  • Advanced Neurosciences Research

    Fort Collins, Colorado, 80528

    (970) 226-6111

    Recruiting

  • Guildford Neurologic Research Partners, LLC

    Greensboro, North Carolina, 27405

    (336) 516-9103

    Recruiting

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

    (336) 574-8000

    Recruiting

  • DelRicht Research

    Gulfport, Mississippi, 39503

    (228) 588-8268

    Recruiting

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

    (314) 972-9600

    Recruiting

  • Victorium Clinical Research

    Houston, Texas, 77024

    (832) 203-7026

    Recruiting

  • DM Clinical Research

    Houston, Texas, 77081

    (346) 550-9559

    Recruiting

  • Axiom Research, Orange County

    Irvine, California, 92604

    (909) 824-2325

    Recruiting

  • AMR Clinical - Kansas City

    Kansas City, Missouri, 64114

    (816) 643-4153

    Recruiting

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin, 53144

    (847) 406-8080

    Recruiting

  • GMG Clinical Research, LLC dba Radiance Clinical Research

    Lampasas, Texas, 76550

    (512) 556-4130

    Recruiting

  • IMA Clinical Research - Las Vegas

    Las Vegas, Nevada, 89102

    (702) 527-7401

    Recruiting

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

    (702) 680-1500

    Recruiting

  • Wake Research Las Vegas Rainbow

    Las Vegas, Nevada, 89118

    (702) 893-8968

    Recruiting

  • AMR Clinical - Las Vegas

    Las Vegas, Nevada, 89119

    (702) 529-0153

    Recruiting

  • Redbird Research

    Las Vegas, Nevada, 89119

    (702) 577-2000

    Recruiting

  • AMR Clinical - Lexington

    Lexington, Kentucky, 40509

    (859) 264-8999

    Recruiting

  • CTI Clinical Research Center

    Lexington, Kentucky, 45212

    (513) 721-3868

    Recruiting

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

    (501) 480-5088

    Recruiting

  • Downtown L.A. Research Center, Inc.

    Los Angeles, California, 90017

    (213) 261-3680

    Recruiting

  • Clinical Research Institute

    Los Angeles, California, 90048

    (323) 879-9999

    Recruiting

  • Central New York Clinical Research

    Manlius, New York, 13104

    (315) 682-3263

    Recruiting

  • Drug Studies America

    Marietta, Georgia, 30060

    (678) 581-5252

    Recruiting

  • Hometown Research

    Milford, Ohio, 45150

    (513) 831-5900

    Recruiting

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

    (612) 333-2200 ext. 5

    Recruiting

  • M3 Wake Research - Mission Mental Health (WR-MMH)

    Mission Viejo, California, 92691

    (949) 752-7910

    Recruiting

  • AMR Mobile

    Mobile, Alabama, 36608

    (251) 901-2127

    Recruiting

  • Frontier Clinical Research

    Morgantown, West Virginia, 26505

    (304) 241-1648

    Recruiting

  • Chicago Headache Center & Research Institute

    Naperville, Illinois, 60563

    (415) 397-0700

    Recruiting

  • Access Clinical Trials, Inc

    Nashville, Tennessee, 37203

    (615) 320-6076

    Recruiting

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

    (615) 329-0197

    Recruiting

  • DelRicht Research

    New Orleans, Louisiana, 70115

    (504) 336-2667

    Recruiting

  • Fieve Clinical Research, Inc

    New York, New York, 10017

    (212) 772-3570

    Recruiting

  • Health Research of Hampton Roads, Inc. (HRHR)

    Newport News, Virginia, 23606

    (757) 591-8100

    Recruiting

  • AMR Clinical - Norfolk

    Norfolk, Virginia, 23502

    (757) 614-1001

    Recruiting

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

    (843) 856-3784

    Recruiting

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030

    (702) 637-3223

    Recruiting

  • Excell Research

    Oceanside, California, 92056

    (760) 758-2222

    Recruiting

  • Advanced Research Institute

    Ogden, Utah, 84405

    (801) 409-2040

    Recruiting

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

    (405) 479-8331

    Recruiting

  • Collective Medical Research

    Overland Park, Kansas, 66212

    (913) 381-7180

    Recruiting

  • Clinical Associates Midwest, LLC

    Overland Park, Kansas, 66214

    (913) 359-5699

    Recruiting

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania, 19114

    (215) 676-6696

    Recruiting

  • Headlands Research - PharmaSite

    Pikesville, Maryland, 21208

    (410) 602-1440

    Recruiting

  • Preferred Primary Care Physicians, Inc.

    Pittsburgh, Pennsylvania, 15236

    (412) 650-6155

    Recruiting

  • Aim Trials, LLC

    Plano, Texas, 75093

    (214) 856-2778

    Recruiting

  • Empire Clinical Research

    Pomona, California, 91767

    (909) 981-5321

    Recruiting

  • The Neurology Group

    Pomona, California, 91767

    (909) 982-2719 ext. 603

    Recruiting

  • Summit Research Network

    Portland, Oregon, 97210

    (855) 367-8834

    Recruiting

  • Advanced Research Institute - Portland

    Portland, Oregon, 97223

    (503) 610-0033

    Recruiting

  • Eximia Research - NC, LLC

    Raleigh, North Carolina, 27607

    (919) 800-5154

    Recruiting

  • Advanced Research Institute - Reno

    Reno, Nevada, 89511

    (775) 502-1616

    Recruiting

  • Proven Endpoints

    Ridgeland, Mississippi, 39157

    (601) 790-1811

    Recruiting

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

    (855) 367-8834

    Recruiting

  • Granger Medical Clinic

    Riverton, Utah, 84096

    (801) 302-1769

    Recruiting

  • Rochester Clinical Research

    Rochester, New York, 14609

    (585) 288-0890

    Recruiting

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah, 84109

    (801) 486-3021 ext. 3315

    Recruiting

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah, 84121

    (801) 365-1032 ext. 3538

    Recruiting

  • Acclaim Clinical Research

    San Diego, California, 92120

    (855) 367-8834

    Recruiting

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania, 15683

    (724) 220-5281

    Recruiting

  • Seattle Clinical Research Center

    Seattle, Washington, 98104

    (206) 522-3330

    Recruiting

  • Carolina Research Center, Inc

    Shelby, North Carolina, 28150

    (704) 487-5228

    Recruiting

  • CenExel Sherman Oaks CA (California Neuroscience Research)

    Sherman Oaks, California, 91403

    (818) 990-2671

    Recruiting

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

    (724) 569-8036

    Recruiting

  • Encompass Clinical Research

    Spring Valley, California, 91978

    (619) 660-9068

    Recruiting

  • Clinvest Headlands LLC

    Springfield, Missouri, 65807

    (417) 883-7889

    Recruiting

  • Sundance Clinical Research

    St Louis, Missouri, 63141

    (314) 567-3377

    Recruiting

  • Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge

    Stockbridge, Georgia, 30281

    (770) 626-0177

    Recruiting

  • DelRicht Research

    Tulsa, Oklahoma, 74133

    (918) 932-2276

    Recruiting

  • Sunwise Clinical Research

    Walnut Creek, California, 94596

    (925) 298-5147

    Recruiting

  • Diablo Clinical Research

    Walnut Creek, California, 94598

    (925) 930-7267

    Recruiting

  • MedVadis Research Corporation, LLC

    Waltham, Massachusetts, 02451

    (781) 373-2940

    Recruiting

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

    (203) 419-4404

    Recruiting

  • Clinpoint Trials

    Waxahachie, Texas, 75165

    (972) 937-1640

    Recruiting

  • CincyScience

    West Chester, Ohio, 45069

    (513) 646-4864

    Recruiting

  • Kinetic Clinical Research

    West Covina, California, 91790

    (657) 230-7120

    Recruiting

  • Integrated Clinical Trials Solution

    West Des Moines, Iowa, 50265

    (515) 223-2300

    Recruiting

  • Focus Clinical Research

    West Hills, California, 91307

    (818) 253-8966

    Recruiting

  • Heartland Research Associates, LLC - An AMR Company

    Wichita, Kansas, 67207

    (316) 689-6635

    Recruiting

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

    (716) 626-6320

    Recruiting

  • Tekton Research, Inc.

    Yukon, Oklahoma, 73099

    (405) 281-3433

    Recruiting

Other trials in United States

About this study

Official title: 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.

Conditions
Migraine
Being tested
Elismetrep, Placebo
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElismetrepDrug

    Also called K-304

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT07645924
Study groupRoleWhat they receive
Elismetrep 10 mgExperimentalNot described
Receives: Drug: Elismetrep
Elismetrep 20 mgExperimentalNot described
Receives: Drug: Elismetrep
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain freedom at 2 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).

    Measured: Two hours post-dose

  2. Freedom from most bothersome symptoms (MBS) at 2 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).

    Measured: Two hours post-dose

Secondary outcomes (14)

  1. Pain relief at 2 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.

    Measured: Two hours post-dose

  2. Sustained pain freedom 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.

    Measured: From 2 to 48 hours post-dose

  3. Freedom from functional disability at 2 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).

    Measured: Two hours post-dose

  4. Pain relief at 60 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

    Measured: Sixty minutes post-dose

  5. Proportion requiring rescue medication within 24 hours post-dose

    Percentage of participants that take rescue medication within 24 hours post-dose.

    Measured: Within 24 hours post-dose

  6. Freedom from photophobia at 2 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.

    Measured: Two hours post-dose

  7. Freedom from phonophobia at 2 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.

    Measured: Two hours post-dose

  8. Freedom from nausea at 2 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.

    Measured: Two hours post-dose

  9. Sustained pain freedom 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.

    Measured: From 2 to 24 hours post-dose

  10. Sustained pain relief 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.

    Measured: From 2 to 48 hours post-dose

  11. Sustained pain relief 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.

    Measured: From 2 to 24 hours post-dose

  12. Pain relapse 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.

    Measured: From 2 to 48 hours post-dose

  13. Percentage of participants who experience one or more treatment-emergent adverse events (AEs)

    Measured: Up to 8 days post-dose

  14. Percentage of participants who experience one or more treatment-emergent serious adverse events (SAEs)

    Measured: Up to 8 days post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start1 Jul 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07645924
Sponsor's protocol ID
K-304 P003
Status last verified
Aug 2026
First submitted
9 Jun 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elismetrep in people with Migraine, run by TriGemX Bio, Inc. at 113 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Annemarie Vance (917-336-3654, annemarie@kallyope.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain freedom at 2 hours post-dose (time frame: Two hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07645924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in