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Acute MigrainePhase 3NCT07674654

A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine

A Phase 3 study testing Elismetrep in people with Acute 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 long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Migraine
What is being tested?
Elismetrep
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
113 sitesUnited States
Study dates
3 Aug 2026to Jun 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins' in the base study and completed the 2-hour and 4-hour post-dose assessments in the eDiary.
  • Note: If a subject treats their qualifying migraine in the base study within 5 days of randomization (i.e. ≤ 4 daily check-ins should have been completed in the eDiary), they are eligible for this study if they missed 1 daily check-in, even though compliance was <80%;
  • Participant voluntarily agrees to participate in the study by giving written informed consent;
  • Participant is able to read, understand, and complete the study questionnaires and diary;
  • Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;
  • Participant is willing to use his/her own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration of the study;
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  • For females of reproductive potential (as determined in the base study), continues to agree to remain abstinent from heterosexual activity or a. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the EoS visit.
  • Acceptable methods of birth control are:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral; injectable; implantable; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence*; 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).
  • Abstinence can be used as the sole method of contraception if it is in line with the participant'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.

Who cannot join

  • Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study);
  • Has, at the time of the base study EoS/Visit 3, had any change in medical history or a laboratory finding since screening in the acute treatment study that in the opinion of the investigator renders the participant unsuitable for this study (e.g., development of a finding that would have precluded participation in the base acute treatment study);
  • Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS) taken during the base study E0S/Visit 3, or of harm to others in the opinion of the investigator. Participants 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 'since last version' version of the C-SSRS;
  • Participant 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 trial participation) as assessed for the base study E0S/Visit 3;
  • Has any major surgery scheduled for the duration of the trial;
  • Has any other 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 the interpretation of efficacy and/or safety results;
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  • At Visit 1, has an open/ongoing adverse event from the base study EoS visit;
  • Experienced a serious adverse event in the base study;
  • Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.

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

    Recruiting

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18103

    Recruiting

  • Dent Neuro Institute, Buffalo

    Amherst, New York, 14226

    Recruiting

  • Michigan Headache Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

    Recruiting

  • DelRicht Research

    Atlanta, Georgia, 30329

    Recruiting

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

    Recruiting

  • Tekton Research

    Austin, Texas, 78745

    Recruiting

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

    Bardstown, Kentucky, 40004

    Recruiting

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

    Birmingham, Alabama, 35205

    Recruiting

  • Boston Clinical Trials - Alcanza

    Boston, Massachusetts, 02131

    Recruiting

  • Pantheon Clinical Research

    Bountiful, Utah, 84010

    Recruiting

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

    Recruiting

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112

    Recruiting

  • Crescent City Headache & Neurology Center

    Chalmette, Louisiana, 70043

    Recruiting

  • TrialSphere

    Chandler, Arizona, 85286

    Recruiting

  • OnSite Clinical Solutions

    Charlotte, North Carolina, 28277

    Recruiting

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

    Recruiting

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

    Recruiting

  • Chicago Headache Center & Research Institute

    Chicago, Illinois, 60657

    Recruiting

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

    Recruiting

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910

    Recruiting

  • Axiom Research, LLC

    Colton, California, 92324

    Recruiting

  • Hometown Research

    Columbus, Ohio, 43228

    Recruiting

  • True North Neurology

    Commack, New York, 11725

    Recruiting

  • ProScience Research Group

    Culver City, California, 90230

    Recruiting

  • APD Clinical Research

    Cypress, Texas, 77372

    Recruiting

  • Horizon Clinical Research and Gill Neuroscience

    Cypress, Texas, 77429

    Recruiting

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75251

    Recruiting

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

    Draper, Utah, 84020

    Recruiting

  • OK Clinical Research, LLC

    Edmond, Oklahoma, 73034

    Recruiting

  • Leading Edge Research LA, LLC

    Encino, California, 91316

    Recruiting

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60447

    Recruiting

  • Advanced Neurosciences Research

    Fort Collins, Colorado, 80528

    Recruiting

  • Guilford Neurologic Research Partners, LLC

    Greensboro, North Carolina, 27405

    Recruiting

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

    Recruiting

  • DelRicht Research

    Gulfport, Mississippi, 39503

    Recruiting

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

    Recruiting

  • Victorium Clinical Research

    Houston, Texas, 77024

    Recruiting

  • DM Clinical Research

    Houston, Texas, 77081

    Recruiting

  • Axiom Research, Orange County

    Irvine, California, 92604

    Recruiting

  • AMR Clinical - Kansas City

    Kansas City, Missouri, 64114

    Recruiting

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin, 53144

    Recruiting

  • GMG Clinical Research, LLC dba Radiance Clinical Research

    Lampasas, Texas, 76550

    Recruiting

  • IMA Clinical Research - Las Vegas

    Las Vegas, Nevada, 89102

    Recruiting

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

    Recruiting

  • Wake Research Las Vegas Rainbow

    Las Vegas, Nevada, 89118

    Recruiting

  • AMR Clinical - Las Vegas

    Las Vegas, Nevada, 89119

    Recruiting

  • Redbird Research

    Las Vegas, Nevada, 89119

    Recruiting

  • AMR Clinical - Lexington

    Lexington, Kentucky, 40509

    Recruiting

  • CTI Clinical Research Center

    Lexington, Kentucky, 45212

    Recruiting

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

    Recruiting

  • Downtown L.A. Research Center, Inc.

    Los Angeles, California, 90017

    Recruiting

  • Clinical Research Institute

    Los Angeles, California, 90048

    Recruiting

  • Central New York Clinical Research

    Manlius, New York, 13104

    Recruiting

  • Drug Studies America

    Marietta, Georgia, 30060

    Recruiting

  • Hometown Research

    Milford, Ohio, 45150

    Recruiting

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

    Recruiting

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

    Mission Viejo, California, 92691

    Recruiting

  • AMR Mobile

    Mobile, Alabama, 36608

    Recruiting

  • Frontier Clinical Research

    Morgantown, West Virginia, 26505

    Recruiting

  • Chicago Headache Center & Research Institute

    Naperville, Illinois, 60563

    Recruiting

  • Access Clinical Trials Inc

    Nashville, Tennessee, 37203

    Recruiting

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

    Recruiting

  • DelRicht Research

    New Orleans, Louisiana, 70115

    Recruiting

  • Fieve Clinical Research, Inc

    New York, New York, 10017

    Recruiting

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

    Newport News, Virginia, 23606

    Recruiting

  • AMR Clinical - Norfolk

    Norfolk, Virginia, 23502

    Recruiting

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

    Recruiting

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030

    Recruiting

  • Excell Research

    Oceanside, California, 92056

    Recruiting

  • Advanced Research Institute

    Ogden, Utah, 84405

    Recruiting

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

    Recruiting

  • Collective Medical Research

    Overland Park, Kansas, 66212

    Recruiting

  • Clinical Associates Midwest, LLC

    Overland Park, Kansas, 66214

    Recruiting

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania, 19114

    Recruiting

  • Headlands Research - PharmaSite

    Pikesville, Maryland, 21208

    Recruiting

  • Preferred Primary Care Physicians, Inc.

    Pittsburgh, Pennsylvania, 15236

    Recruiting

  • Aim Trials, LLC

    Plano, Texas, 75093

    Recruiting

  • Empire Clinical Research

    Pomona, California, 91767

    Recruiting

  • The Neurology Group

    Pomona, California, 91767

    Recruiting

  • Summit Research Network

    Portland, Oregon, 97210

    Recruiting

  • Advanced Research Institute-Portland

    Portland, Oregon, 97223

    Recruiting

  • Eximia Research - NC, LLC

    Raleigh, North Carolina, 27607

    Recruiting

  • Advanced Research Institute-Reno

    Reno, Nevada, 89511

    Recruiting

  • Proven Endpoints

    Ridgeland, Mississippi, 39157

    Recruiting

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

    Recruiting

  • Granger Medical Clinic

    Riverton, Utah, 84096

    Recruiting

  • Rochester Clinical Research

    Rochester, New York, 14609

    Recruiting

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

    Salt Lake City, Utah, 84109

    Recruiting

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

    Salt Lake City, Utah, 84121

    Recruiting

  • Acclaim Clinical Research

    San Diego, California, 92120

    Recruiting

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania, 15683

    Recruiting

  • Seattle Clinical Research Center

    Seattle, Washington, 98104

    Recruiting

  • Carolina Research Center, Inc

    Shelby, North Carolina, 28150

    Recruiting

  • CenExel Sherman Oaks CA (California Neuroscience Research)

    Sherman Oaks, California, 91403

    Recruiting

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

    Recruiting

  • Encompass Clinical Research

    Spring Valley, California, 91978

    Recruiting

  • Clinvest Headlands LLC

    Springfield, Missouri, 65807

    Recruiting

  • Sundance Clinical Research

    St Louis, Missouri, 63141

    Recruiting

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

    Stockbridge, Georgia, 30281

    Recruiting

  • DelRicht Research

    Tulsa, Oklahoma, 74133

    Recruiting

  • Sunwise Clinical Research

    Walnut Creek, California, 94596

    Recruiting

  • Diablo Clinical Research

    Walnut Creek, California, 94598

    Recruiting

  • MedVadis Research Corporation, LLC

    Waltham, Massachusetts, 02451

    Recruiting

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

    Recruiting

  • ClinPoint Trials

    Waxahachie, Texas, 75165

    Recruiting

  • CincyScience

    West Chester, Ohio, 45069

    Recruiting

  • Kinetic Clinical Research

    West Covina, California, 91790

    Recruiting

  • Integrated Clinical Trials Solution

    West Des Moines, Iowa, 50265

    Recruiting

  • Focus Clinical Research

    West Hills, California, 91307

    Recruiting

  • Heartland Research Associates, LLC - An AMR Company

    Wichita, Kansas, 67207

    Recruiting

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

    Recruiting

  • Tekton Research, Inc.

    Yukon, Oklahoma, 73099

    Recruiting

Other trials in United States

About this study

This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.

Conditions
Acute Migraine
Being tested
Elismetrep

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

Study groups in NCT07674654
Study groupRoleWhat they receive
Elismetrep 10 mgExperimentalParticipants were randomised to receive elismetrep at a dose of 10 mg
Receives: Drug: Elismetrep
Elismetrep 20 mgExperimentalParticipants were randomised to receive elismetrep at a dose of 20 mg
Receives: Drug: Elismetrep

What is being measured

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

  1. Proportion of participants with at least one treatment-emergent adverse event (TEAE)

    Measured: Through study completion, an average of 1 year

  2. Proportion of participants with at least one treatment-emergent serious adverse event (SAE)

    Measured: Through study completion, an average of 1 year

  3. Proportion of participants with TEAEs leading to study drug discontinuation

    Measured: Through study completion, an average of 1 year

  4. Proportion of participants with TEAEs that occur in at least 5% of treated participants in either treatment arm

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted29 Jun 2026
  2. Study start3 Aug 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07674654
Sponsor's protocol ID
K-304 P005
Status last verified
Aug 2026
First submitted
15 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 Acute 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 10 inclusion and 9 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. 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?

Proportion of participants with at least one treatment-emergent adverse event (TEAE) (time frame: Through study completion, an average of 1 year). The study lists 4 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 NCT07674654.

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.

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