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

NCT07645924 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: K-304 P003
• Study Type: interventional
• Target: 1,800
• Locations: 2 countries
• Sites: 120

Brief 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• 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).

  Two hours post-dose

• 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).

  Two hours post-dose

Secondary Outcomes (14)

• Pain relief at 2 hours post-dose

  Two hours post-dose

• Sustained pain freedom from 2 to 48 hours post-dose

  From 2 to 48 hours post-dose

• Freedom from functional disability at 2 hours post-dose

  Two hours post-dose

• Pain relief at 60 minutes post-dose

  Sixty minutes post-dose

• Proportion requiring rescue medication within 24 hours post-dose

  Within 24 hours post-dose

Study Arms (3)

Elismetrep 10 mg

EXPERIMENTAL

Drug: Elismetrep

Elismetrep 20 mg

EXPERIMENTAL

Drug: Elismetrep

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Elismetrep DRUG

Administered orally

Also known as: K-304

Elismetrep 10 mg; Elismetrep 20 mg

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:
• 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:
• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Kallyope Inc.: lead

Study Sites (120)

Central Research Associates, LLC (CRA) dba Flourish Research

Birmingham, Alabama, 35205, United States

Location

AMR Mobile

Mobile, Alabama, 36608, United States

Location

TrialSphere

Chandler, Arizona, 85286, United States

Location

Arkansas Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Axiom Research, LLC

Colton, California, 92324, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Leading Edge Research LA, LLC

Encino, California, 91316, United States

Location

Axiom Research, Orange County

Irvine, California, 92604, United States

Location

Downtown L.A. Research Center, Inc.

Los Angeles, California, 90017, United States

Location

Clinical Research Institute

Los Angeles, California, 90048, United States

Location

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

Mission Viejo, California, 92691, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

The Neurology Group

Pomona, California, 91767, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

CenExel Sherman Oaks CA (California Neuroscience Research)

Sherman Oaks, California, 91403, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Sunwise Clinical Research

Walnut Creek, California, 94596, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Kinetic Clinical Research

West Covina, California, 91790, United States

Location

Focus Clinical Research

West Hills, California, 91307, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

Location

Advanced Neurosciences Research

Fort Collins, Colorado, 80528, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

DelRicht Research

Atlanta, Georgia, 30329, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

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

Stockbridge, Georgia, 30281, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Chicago Headache Center & Research Institute

Chicago, Illinois, 60657, United States

Location

Healthcare Research Network II, LLC

Flossmoor, Illinois, 60477, United States

Location

Chicago Headache Center & Research Institute

Naperville, Illinois, 60563, United States

Location

Integrated Clinical Trials Solution

West Des Moines, Iowa, 50265, United States

Location

Collective Medical Research

Overland Park, Kansas, 66212, United States

Location

Clinical Associates Midwest, LLC

Overland Park, Kansas, 66214, United States

Location

Heartland Research Associates, LLC - An AMR Company

Wichita, Kansas, 67207, United States

Location

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

Bardstown, Kentucky, 40004, United States

Location

AMR Clinical - Lexington

Lexington, Kentucky, 40509, United States

Location

CTI Clinical Research Center

Lexington, Kentucky, 45212, United States

Location

Monroe Biomedical Research (former L-MARC Research Center)

Louisville, Kentucky, 40213, United States

Location

Crescent City Headache & Neurology Center

Chalmette, Louisiana, 70043, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Headlands Research - PharmaSite

Pikesville, Maryland, 21208, United States

Location

Boston Clinical Trials - Alcanza

Boston, Massachusetts, 02131, United States

Location

MedVadis Research Corporation, LLC

Waltham, Massachusetts, 02451, United States

Location

Michigan Headache Pain & Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Minneapolis Clinic of Neurology

Burnsville, Minnesota, 55337, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

DelRicht Research

Gulfport, Mississippi, 39503, United States

Location

Proven Endpoints

Ridgeland, Mississippi, 39157, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

AMR Clinical - Kansas City

Kansas City, Missouri, 64114, United States

Location

Clinvest Headlands LLC

Springfield, Missouri, 65807, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

IMA Clinical Research - Las Vegas

Las Vegas, Nevada, 89102, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Wake Research Las Vegas Rainbow

Las Vegas, Nevada, 89118, United States

Location

AMR Clinical - Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Redbird Research

Las Vegas, Nevada, 89119, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

Location

Advanced Research Institute - Reno

Reno, Nevada, 89511, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Dent Neuro Institute, Buffalo

Amherst, New York, 14226, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

True North Neurology

Commack, New York, 11725, United States

Location

Central New York Clinical Research

Manlius, New York, 13104, United States

Location

Fieve Clinical Research, Inc

New York, New York, 10017, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

OnSite Clinical Solutions

Charlotte, North Carolina, 28277, United States

Location

Guildford Neurologic Research Partners, LLC

Greensboro, North Carolina, 27405, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27405, United States

Location

Eximia Research - NC, LLC

Raleigh, North Carolina, 27607, United States

Location

Carolina Research Center, Inc

Shelby, North Carolina, 28150, United States

Location

Hometown Research

Columbus, Ohio, 43228, United States

Location

Hometown Research

Huber Heights, Ohio, 45424, United States

Location

Hometown Research

Milford, Ohio, 45150, United States

Location

CincyScience

West Chester, Ohio, 45069, United States

Location

OK Clinical Research, LLC

Edmond, Oklahoma, 73034, United States

Location

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

Location

DelRicht Research

Tulsa, Oklahoma, 74133, United States

Location

Tekton Research, Inc.

Yukon, Oklahoma, 73099, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Advanced Research Institute - Portland

Portland, Oregon, 97223, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18103, United States

Location

Clinical Research Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

Preferred Primary Care Physicians, Inc.

Pittsburgh, Pennsylvania, 15236, United States

Location

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States

Location

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Access Clinical Trials, Inc

Nashville, Tennessee, 37203, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

APD Clinical Research

Cypress, Texas, 77372, United States

Location

Horizon Clinical Research and Gill Neuroscience

Cypress, Texas, 77429, United States

Location

Relaro Medical Trials, LLC

Dallas, Texas, 75243, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75251, United States

Location

Helios CR, Inc. - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Victorium Clinical Research

Houston, Texas, 77024, United States

Location

DM Clinical Research

Houston, Texas, 77081, United States

Location

Helios CR, Inc. - Keller

Keller, Texas, 76248, United States

Location

GMG Clinical Research, LLC dba Radiance Clinical Research

Lampasas, Texas, 76550, United States

Location

Aim Trials, LLC

Plano, Texas, 75093, United States

Location

Clinpoint Trials

Waxahachie, Texas, 75165, United States

Location

Pantheon Clinical Research

Bountiful, Utah, 84010, United States

Location

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

Draper, Utah, 84020, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Granger Medical Clinic

Riverton, Utah, 84096, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84121, United States

Location

Health Research of Hampton Roads, Inc. (HRHR)

Newport News, Virginia, 23606, United States

Location

AMR Clinical - Norfolk

Norfolk, Virginia, 23502, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98104, United States

Location

Frontier Clinical Research

Morgantown, West Virginia, 26505, United States

Location

Clinical Investigation Specialists, Inc.

Kenosha, Wisconsin, 53144, United States

Location

Solace Clinical Research

San Juan, 00907, Puerto Rico

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Annemarie Vance

CONTACT

917-336-3654; annemarie@kallyope.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (119); PR (1)