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

NCT07816367 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: K-304 P004
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 72

Brief Summary

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• Pain freedom at 2 hours post-dose

  Percentage of subjects who 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 subjects who 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 (13)

• Pain relief at 2 hours post-dose

  Two hours post-dose

• Sustained pain freedom from 2 to 24 hours post-dose

  From 2 to 24 hours post-dose

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

  From 2 to 48 hours post-dose

• Sustained pain relief from 2 to 24 hours post-dose

  From 2 to 24 hours post-dose

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

  From 2 to 48 hours post-dose

Study Arms (3)

Elismetrep 10 mg

EXPERIMENTAL

Participants received a single dose of elismetrep 10 mg

Drug: Elismetrep

Elismetrep 20 mg

EXPERIMENTAL

Participants received a single dose of elismetrep 20 mg

Drug: Elismetrep

Placebo

PLACEBO COMPARATOR

Participants received a single dose of placebo

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.
• \. 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 as documented in the patient's medical records from his/her treating physician or with pharmacy records confirming use of a migraine-specific medication (e.g. triptan, gepant, ditan) for \> 1 year, and confirmed by the investigator. 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 subject'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;

You may not qualify if:

• Patients 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 study. Note: Female participants of child-bearing potential must have a negative serum pregnancy test (β-human chorionic gonadotropin) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.
• 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 (72)

Sun City Clinical Research

Glendale, Arizona, 85304, United States

Location

Velocity Clinical Research, Phoenix

Phoenix, Arizona, 85006, United States

Location

IMA Clinical Research - Phoenix

Phoenix, Arizona, 85012, United States

Location

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Alliance Research Institute, Canoga Park

Canoga Park, California, 91304, United States

Location

Velocity Clinical Research, Chula Vista

Chula Vista, California, 91911, United States

Location

Ark Clinical Research, Fountain Valley

Fountain Valley, California, 92708, United States

Location

Neurology Center of North Orange County

Fullerton, California, 92835, United States

Location

Axiom Research, Los Angeles LLC

Glendale, California, 91206, United States

Location

Long Beach Clinical Trials Services, Inc

Long Beach, California, 90806, United States

Location

Accellacare - Long Beach

Long Beach, California, 90807, United States

Location

Alliance Research Institute, Lynwood

Lynwood, California, 90262, United States

Location

Northridge Clinical Trials

Northridge, California, 91325, United States

Location

Pasadena Clinical Trials

Pasadena, California, 91101, United States

Location

Paradigm Clinical Research Centers, LLC

Redding, California, 96001, United States

Location

Infinity Clinical Trials

San Diego, California, 92108, United States

Location

Paradigm Clinical Research Centers, LLC

San Diego, California, 92108, United States

Location

Optimus Medical Group

San Francisco, California, 94102, United States

Location

Paragon Rx Clinical

Santa Ana, California, 92703, United States

Location

Velocity Clinical Research, Van Nuys

Van Nuys, California, 91606, United States

Location

Paradigm Clinical Research Centers, LLC; Aurora

Aurora, Colorado, 80012, United States

Location

Centennial Clinical Trials

Denver, Colorado, 80246, United States

Location

Ki Health Partners, LLC

Stamford, Connecticut, 06905-1206, United States

Location

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States

Location

Clinical Research of Central Florida

Lakeland, Florida, 33805, United States

Location

AppleMedical Research Group, LLC

Miami, Florida, 33155, United States

Location

Sensible Healthcare, LLC

Ocoee, Florida, 34761, United States

Location

Clinical Associates of Orlando, LLC

Orlando, Florida, 32819, United States

Location

Cenexel Tampa FL

Tampa, Florida, 33613, United States

Location

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, 30328, United States

Location

Evergreen Clinical Trials

Norcross, Georgia, 30092, United States

Location

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

Location

Paradigm Clinical Research Centers, LLC

Boise, Idaho, 83709, United States

Location

Clinical Investigation Specialists, Inc.

Gurnee, Illinois, 60031, United States

Location

Evanston Premier Healthcare Research, LLC

Skokie, Illinois, 60077, United States

Location

DM Clinical Research, Indianapolis

Indianapolis, Indiana, 46254, United States

Location

Indiana Medical Research Institute

Merrillville, Indiana, 46410, United States

Location

Accellacare - McFarland |

Ames, Iowa, 50010, United States

Location

Velocity Clinical Research, Sioux City

Sioux City, Iowa, 51106, United States

Location

NECCR PrimaCare Research, LLC

Fall River, Massachusetts, 02721, United States

Location

Neurology Center of New England P.C.

Foxborough, Massachusetts, 02035, United States

Location

Montana Medical Research, Inc

Missoula, Montana, 59808, United States

Location

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, 68701, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

Oasis Clinical Research

Las Vegas, Nevada, 89121, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

Accellacare - Cary (Cary Medical Group)

Cary, North Carolina, 27518, United States

Location

West Clinical Research

Morehead City, North Carolina, 28557, United States

Location

Accellacare - Raleigh (Raleigh Medical Group, P.A.)

Raleigh, North Carolina, 27609, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28401, United States

Location

Accellacare - Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Lillestol Research

Fargo, North Dakota, 58104, United States

Location

Velocity Clinical Research, Cleveland

Beachwood, Ohio, 44122, United States

Location

Velocity Clinical Research, Cincinnati, Blue Ash

Blue Ash, Ohio, 45242, United States

Location

Headache Center of Hope

Cincinnati, Ohio, 45236, United States

Location

Centricity Research; Columbus, Ohio

Columbus, Ohio, 43213, United States

Location

Velocity Clinical Research, Providence

Providence, Rhode Island, 02818, United States

Location

Velocity Clinical Research, Anderson

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research, Gaffney

Gaffney, South Carolina, 29340, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Gadolin Research, LLC

Beaumont, Texas, 77702, United States

Location

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

Location

Epic Medical Research - DeSoto

DeSoto, Texas, 75115, United States

Location

Newco 3A Researh LLC, DBA 3A Research

El Paso, Texas, 79902, United States

Location

Red Star Research

Lake Jackson, Texas, 77566, United States

Location

Clinical Trials of Texas, LLC, A Flourish Research Site

San Antonio, Texas, 78229, United States

Location

San Antonio Clinical Trials

San Antonio, Texas, 78240, United States

Location

DM Clinical Research, Sugar Land

Sugar Land, Texas, 77479, United States

Location

DM Clinical Research, Tomball

Tomball, Texas, 77375, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

Highland Clinical Research

Salt Lake City, Utah, 84124, United States

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: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (72)