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Migraine drug tested for Long-Term safety in 1,000-Person trial

NCT ID NCT07674654

Symptom relief Sponsor: Kallyope Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Aug 28, 2026 · Updated 8 times

Summary

This phase 3 study evaluates the long-term safety of elismetrep (K-304), an oral medication taken as needed for migraine attacks. About 1,000 adults who previously took elismetrep in an earlier trial will continue using it intermittently. Researchers will track side effects over time to see if the drug remains safe for repeated use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elismetrep (K-304)
What this could lead to
If successful, this could confirm that elismetrep is safe for repeated use, offering a new option for treating migraine attacks as they happen.
What could go wrong
This is a safety-focused study, not designed to prove how well the drug works. Side effects may emerge with long-term use, and results may not apply to everyone with migraine.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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%; 2. Participant voluntarily agrees to participate in the study by giving written informed consent; 3. Participant is able to read, understand, and complete the study questionnaires and diary; 4. Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions; 5. 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; 6. 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: i. 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. Exclusion Criteria: 1. 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); 2. 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); 3. 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; 4. 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; 5. Has any major surgery scheduled for the duration of the trial; 6. 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; 7. At Visit 1, has an open/ongoing adverse event from the base study EoS visit; 8. Experienced a serious adverse event in the base study; 9. Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    113 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AMR Clinical - Kansas City

    RECRUITING

    Kansas City, Missouri, 64114, United States

  • AMR Clinical - Las Vegas

    RECRUITING

    Las Vegas, Nevada, 89119, United States

  • AMR Clinical - Lexington

    RECRUITING

    Lexington, Kentucky, 40509, United States

  • AMR Clinical - Norfolk

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • AMR Mobile

    RECRUITING

    Mobile, Alabama, 36608, United States

  • APD Clinical Research

    RECRUITING

    Cypress, Texas, 77372, United States

  • Access Clinical Trials Inc

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Acclaim Clinical Research

    RECRUITING

    San Diego, California, 92120, United States

  • Advanced Neurosciences Research

    RECRUITING

    Fort Collins, Colorado, 80528, United States

  • Advanced Research Institute

    RECRUITING

    Ogden, Utah, 84405, United States

  • Advanced Research Institute-Portland

    RECRUITING

    Portland, Oregon, 97223, United States

  • Advanced Research Institute-Reno

    RECRUITING

    Reno, Nevada, 89511, United States

  • Aim Trials, LLC

    RECRUITING

    Plano, Texas, 75093, United States

  • Albuquerque Clinical Trials

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • Arkansas Clinical Research

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Artemis Institute for Clinical Research

    RECRUITING

    Riverside, California, 92503, United States

  • Axiom Research, LLC

    RECRUITING

    Colton, California, 92324, United States

  • Axiom Research, Orange County

    RECRUITING

    Irvine, California, 92604, United States

  • Boston Clinical Trials - Alcanza

    RECRUITING

    Boston, Massachusetts, 02131, United States

  • CTI Clinical Research Center

    RECRUITING

    Lexington, Kentucky, 45212, United States

  • Carolina Research Center, Inc

    RECRUITING

    Shelby, North Carolina, 28150, United States

  • Cedar Crosse Research Center

    RECRUITING

    Chicago, Illinois, 60607, United States

  • CenExel Sherman Oaks CA (California Neuroscience Research)

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Central New York Clinical Research

    RECRUITING

    Manlius, New York, 13104, United States

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

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • Chase Medical Research, LLC

    RECRUITING

    Waterbury, Connecticut, 06708, United States

  • Chicago Headache Center & Research Institute

    RECRUITING

    Chicago, Illinois, 60657, United States

  • Chicago Headache Center & Research Institute

    RECRUITING

    Naperville, Illinois, 60563, United States

  • CincyScience

    RECRUITING

    West Chester, Ohio, 45069, United States

  • ClinPoint Trials

    RECRUITING

    Waxahachie, Texas, 75165, United States

  • Clinical Associates Midwest, LLC

    RECRUITING

    Overland Park, Kansas, 66214, United States

  • Clinical Investigation Specialists, Inc.

    RECRUITING

    Kenosha, Wisconsin, 53144, United States

  • Clinical Research Associates, Inc.

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Clinical Research Institute

    RECRUITING

    Los Angeles, California, 90048, United States

  • Clinical Research Institute

    RECRUITING

    Minneapolis, Minnesota, 55402, United States

  • Clinical Research Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19114, United States

  • Clinvest Headlands LLC

    RECRUITING

    Springfield, Missouri, 65807, United States

  • Coastal Carolina Research Center

    RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Collective Medical Research

    RECRUITING

    Overland Park, Kansas, 66212, United States

  • Crescent City Headache & Neurology Center

    RECRUITING

    Chalmette, Louisiana, 70043, United States

  • DM Clinical Research

    RECRUITING

    Houston, Texas, 77081, United States

  • DelRicht Research

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • DelRicht Research

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • DelRicht Research

    RECRUITING

    Gulfport, Mississippi, 39503, United States

  • DelRicht Research

    RECRUITING

    Tulsa, Oklahoma, 74133, United States

  • Dent Neuro Institute, Buffalo

    RECRUITING

    Amherst, New York, 14226, United States

  • Diablo Clinical Research

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Downtown L.A. Research Center, Inc.

    RECRUITING

    Los Angeles, California, 90017, United States

  • Drug Studies America

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Empire Clinical Research

    RECRUITING

    Pomona, California, 91767, United States

  • Encompass Clinical Research

    RECRUITING

    Spring Valley, California, 91978, United States

  • Excel Clinical Research

    RECRUITING

    Las Vegas, Nevada, 89109, United States

  • Excell Research

    RECRUITING

    Oceanside, California, 92056, United States

  • Eximia Research - NC, LLC

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • Fieve Clinical Research, Inc

    RECRUITING

    New York, New York, 10017, United States

  • Focus Clinical Research

    RECRUITING

    West Hills, California, 91307, United States

  • Frontier Clinical Research

    RECRUITING

    Morgantown, West Virginia, 26505, United States

  • Frontier Clinical Research, LLC

    RECRUITING

    Scottdale, Pennsylvania, 15683, United States

  • Frontier Clinical Research, LLC

    RECRUITING

    Smithfield, Pennsylvania, 15478, United States

  • FutureSearch Trials of Dallas, LP

    RECRUITING

    Dallas, Texas, 75251, United States

  • FutureSearch Trials of Neurology

    RECRUITING

    Austin, Texas, 78731, United States

  • GMG Clinical Research, LLC dba Radiance Clinical Research

    RECRUITING

    Lampasas, Texas, 76550, United States

  • Granger Medical Clinic

    RECRUITING

    Riverton, Utah, 84096, United States

  • Guilford Neurologic Research Partners, LLC

    RECRUITING

    Greensboro, North Carolina, 27405, United States

  • Headache Wellness Center

    RECRUITING

    Greensboro, North Carolina, 27405, United States

  • Headlands Research - PharmaSite

    RECRUITING

    Pikesville, Maryland, 21208, United States

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

    RECRUITING

    Newport News, Virginia, 23606, United States

  • Healthcare Research Network

    RECRUITING

    Hazelwood, Missouri, 63042, United States

  • Healthcare Research Network II, LLC

    RECRUITING

    Flossmoor, Illinois, 60447, United States

  • Heartland Research Associates, LLC - An AMR Company

    RECRUITING

    Wichita, Kansas, 67207, United States

  • Hightower Clinical

    RECRUITING

    Oklahoma City, Oklahoma, 73102, United States

  • Hometown Research

    RECRUITING

    Columbus, Ohio, 43228, United States

  • Hometown Research

    RECRUITING

    Milford, Ohio, 45150, United States

  • Horizon Clinical Research and Gill Neuroscience

    RECRUITING

    Cypress, Texas, 77429, United States

  • IMA Clinical Research - Las Vegas

    RECRUITING

    Las Vegas, Nevada, 89102, United States

  • IMMUNOe Research Centers

    RECRUITING

    Centennial, Colorado, 80112, United States

  • Integrated Clinical Trials Solution

    RECRUITING

    West Des Moines, Iowa, 50265, United States

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

    RECRUITING

    Salt Lake City, Utah, 84109, United States

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

    RECRUITING

    Salt Lake City, Utah, 84121, United States

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

    RECRUITING

    Draper, Utah, 84020, United States

  • Kinetic Clinical Research

    RECRUITING

    West Covina, California, 91790, United States

  • Las Vegas Clinical Trials

    RECRUITING

    North Las Vegas, Nevada, 89030, United States

  • Leading Edge Research LA, LLC

    RECRUITING

    Encino, California, 91316, United States

  • Lehigh Center for Clinical Research

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

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

    RECRUITING

    Mission Viejo, California, 92691, United States

  • MCB Clinical Research Centers

    RECRUITING

    Colorado Springs, Colorado, 80910, United States

  • MedVadis Research Corporation, LLC

    RECRUITING

    Waltham, Massachusetts, 02451, United States

  • Michigan Headache Pain & Neurological Institute

    RECRUITING

    Ann Arbor, Michigan, 48104, United States

  • OK Clinical Research, LLC

    RECRUITING

    Edmond, Oklahoma, 73034, United States

  • OnSite Clinical Solutions

    RECRUITING

    Charlotte, North Carolina, 28277, United States

  • Pantheon Clinical Research

    RECRUITING

    Bountiful, Utah, 84010, United States

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

    RECRUITING

    Bardstown, Kentucky, 40004, United States

  • Preferred Primary Care Physicians, Inc.

    RECRUITING

    Pittsburgh, Pennsylvania, 15236, United States

  • ProScience Research Group

    RECRUITING

    Culver City, California, 90230, United States

  • Proven Endpoints

    RECRUITING

    Ridgeland, Mississippi, 39157, United States

  • Redbird Research

    RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Rochester Clinical Research

    RECRUITING

    Rochester, New York, 14609, United States

  • SPRI Clinical Trials, LLC

    RECRUITING

    Brooklyn, New York, 11235, United States

  • Seattle Clinical Research Center

    RECRUITING

    Seattle, Washington, 98104, United States

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

    RECRUITING

    Stockbridge, Georgia, 30281, United States

  • StudyMetrix Research

    RECRUITING

    City of Saint Peters, Missouri, 63303, United States

  • Summit Research Network

    RECRUITING

    Portland, Oregon, 97210, United States

  • Sundance Clinical Research

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Sunwise Clinical Research

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Tekton Research

    RECRUITING

    Austin, Texas, 78745, United States

  • Tekton Research, Inc.

    RECRUITING

    Yukon, Oklahoma, 73099, United States

  • The Neurology Group

    RECRUITING

    Pomona, California, 91767, United States

  • TrialSphere

    RECRUITING

    Chandler, Arizona, 85286, United States

  • True North Neurology

    RECRUITING

    Commack, New York, 11725, United States

  • Upstate Clinical Research Associates

    RECRUITING

    Williamsville, New York, 14221, United States

  • Victorium Clinical Research

    RECRUITING

    Houston, Texas, 77024, United States

  • WR-ClinSearch, LLC

    RECRUITING

    Chattanooga, Tennessee, 37421, United States

  • Wake Research Las Vegas Rainbow

    RECRUITING

    Las Vegas, Nevada, 89118, United States

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