New pill elismetrep aims to zap migraine pain in Mid-Stage trial

NCT ID NCT06848075

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

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This completed Phase IIb trial tested an oral drug called elismetrep (K-304) in 431 adults with moderate or severe migraine. Participants received one of four doses of elismetrep or a placebo. The main goal was to see if the drug could make pain disappear within a set time. Secondary goals included relief from the most bothersome symptom, such as nausea or sensitivity to light or sound. The study was double-blind and placebo-controlled to ensure fair results.

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, elismetrep could offer a new oral option to relieve migraine pain and bothersome symptoms like nausea or light sensitivity.
What could go wrong: This is a Phase IIb trial, so results are still early. The drug may not prove better than placebo, and side effects or lack of lasting benefit are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

431 people

The number who actually took part.

Started

Mar 2025

Finished

Aug 2025

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 to 70 years

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. Be a male or female, age 18 to 70 years, inclusive, at the time of signing informed consent. 2. Participant has greater than a one-year history of migraine with or without aura as defined by International Conference on Harmonization (IHS) criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated as documented in the participant's medical records from his/her treating physician and confirmed by the investigator. 3. Participant has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to screening (Visit 1). 4. Meet the following requirements: 1. Is a male OR 2. Is a female who is of non-childbearing potential defined by at least 1 of the following criteria: 3. Postmenopausal (aged \>45 years and with a minimum of 12 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone (FSH) level in the menopausal range established for the central laboratory. 4. Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the participant's recall of their medical history. OR 5. Is a female of reproductive potential and: 6. agrees to remain abstinent from heterosexual activity\* \*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. 7. or 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 trial (EoT) visit. Acceptable methods of birth control are: * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: * oral * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation: * oral * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasing system (IUS) * bilateral tubal occlusion * vasectomised 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) This condition is waived if the participant is proven to have no child-bearing potential (eg, hysterectomy). 5. Participant voluntarily agrees to participate in the study by giving written informed consent. 6. Participant is able to read, understand and complete the study questionnaires and diary. 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: 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 serum pregnancy test (β-human chorionic gonadotropin (β-hCG)) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit. Migraine history related 2. Participant has difficulty distinguishing his/her migraine attacks from tension-type headaches. 3. Participant has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than two hours. 4. Participant 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 three months prior to screening (Visit 1). 5. Participant has brainstem (a.k.a. basilar-type) or hemiplegic migraine headache, or retinal migraine. 6. Participant was \>50 years old at age of first migraine onset. 7. Participant is taking migraine prophylactic medication where the prescribed daily 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. Participant 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 \[participants who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study\]. 9. Participant 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. 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 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, renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases that, per the investigator's judgement, may jeopardize the participant'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. Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Participants with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening. 13. Has a history of human immunodeficiency virus disease. 14. Participant 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 (ECG) related 15. Has a positive test result at screening for hepatitis B surface antigen (Ag), hepatitis C virus antibody. 16. Has a screening estimated Glomerular Filtration Rate (eGFR) estimated with the Modification of Diet in Renal Disease (MDRD) equation of \<45 ml/min/1.73 m\^2. 17. Has a screening result for alanine aminotransferase or aspartate aminotransferase (ALT or AST) of \>2.0X upper limit of normal (ULN) or total bilirubin \>1.5X ULN at the Screening Visit. Note: An isolated bilirubin \>1.5X ULN is acceptable if bilirubin is fractionated, and direct bilirubin is within the laboratory normal range. 18. Has a corrected QT interval to Fridericia's formula (QTcF) \>450 milliseconds (msec) for males and \>470 msec for females at screening. 19. Has a mean value for triplicate seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure (BP) \>95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's BP is exclusionary on the first triplicate assessment at the Screening Visit, they may have 1 repeat triplicate BP 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: 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. 23. Is currently in violation of study requirements for prohibited and permissible concomitant medications (not already specified in other criteria) or is anticipated to violate these requirements during study participation. 24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation. 25. History of use of ergotamine medications on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months prior to screening. 26. History of non-narcotic analgesic intake on greater than/equal 15 days per month for greater than/equal 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. Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit; 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. 33. Has any other disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results. 34. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.

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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 Migraine

Contacts and locations

Locations

AMR Knoxville (Formerly NOCCR)

Knoxville, Tennessee, 37909, United States
AMR Mobile

Mobile, Alabama, 36608, United States
APD Clinical Research

Splendora, Texas, 77372, United States
Acclaim Clinical Research

San Diego, California, 89109, United States
Advanced Research Institute

Ogden, Utah, 84405, United States
Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States
Alliance for Multispecialty Research

Wichita, Kansas, 67207, United States
Artemis Institute for Clinical Research - Riverside

Riverside, California, 92503, United States
Artemis Institute for Clinical Research - San Diego

San Diego, California, 92103, United States
Atlas-Clinical

West Chester, Pennsylvania, 19380, United States
CNY Clinical Research

Manlius, New York, 13104, United States
CT Clinical Research

Cromwell, Connecticut, 06416, United States
CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States
Cedar Crosse Research Center

Chicago, Illinois, 60607, United States
Central Research Associates, LLC (CRA) dba Flourish Research

Birmingham, Alabama, 35205, United States
ClinPoint Trials

Waxahachie, Texas, 75165, United States
Clinical Investigation Specialist

Kenosha, Wisconsin, 53144, United States
Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States
Clinical Research Atlanta - Stockbridge

Stockbridge, Georgia, 30281, United States
Clinical Research Institute

Minneapolis, Minnesota, 55402, United States
Clinical Research Philadelphia, LLC

Philadelphia, Pennsylvania, 19114, United States
Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States
Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States
Collective Medical Research

Overland Park, Kansas, 66202, United States
Crescent City Headache & Neurology Center

Chalmette, Louisiana, 70043, United States
DelRicht Research

Atlanta, Georgia, 30329, United States
DelRicht Research

New Orleans, Louisiana, 70115, United States
DelRicht Research

Gulfport, Mississippi, 39503, United States
DelRicht Research

Tulsa, Oklahoma, 74133, United States
Dent Neurosciences Research Center

Amherst, New York, 14226, United States
Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States
Donald J Garcia Jr, MD, PA

Austin, Texas, 78737, United States
Empire Clinical Research

Pomona, California, 91767, United States
Excel Clinical Research

Las Vegas, Nevada, 89109, United States
Excell Research, Inc.

Oceanside, California, 92056, United States
Eximia Research - CA

La Mesa, California, 91942, United States
Focus Clinical Research

West Hills, California, 91307, United States
Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States
Frontier Clinical Research, LLC

Morgantown, West Virginia, 26505, United States
FutureSearch Trials of Dallas, LP

Dallas, Texas, 75251, United States
Headache Wellness Center

Greensboro, North Carolina, 27405, United States
Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States
Healthcare Research Network

Hazelwood, Missouri, 63042, United States
Healthcare Research Network II, LLC

Flossmoor, Illinois, 60422, United States
Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States
Hope Clinical Research

Canoga Park, California, 91303, United States
L-MARC Research Center

Louisville, Kentucky, 40213, United States
Las Vegas Clinical Trials

North Las Vegas, Nevada, 89119, United States
Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18103, United States
Marvel Clinical Research

Huntington Beach, California, 92647, United States
Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States
Northwest Clinical Trials

Boise, Idaho, 83704, United States
OK Clinical Research, LLC

Edmond, Oklahoma, 73034, United States
Peters Medical Research

High Point, North Carolina, 27260, United States
Rochester Clinical Research

Rochester, New York, 14609, United States
Summit Research Network

Portland, Oregon, 97210, United States
Synergy San Diego

Lemon Grove, California, 91945, United States
Tekton Research

Yukon, Oklahoma, 73099, United States
Tekton Research

Austin, Texas, 78745, United States
Upstate Clinical Research Associates LLC

Williamsville, New York, 14221, United States
Victorium Clinical Research LTD CO

Houston, Texas, 77024, United States
WR-ClinSearch

Chattanooga, Tennessee, 37421, United States
WR-PRI, LLC (Encino)

Encino, California, 91316, United States
WR-PRI, LLC (Newport Beach)

Newport Beach, California, 92660, United States
Wake Research/ Tucson Neuroscience Research

Tucson, Arizona, 85710, United States

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