A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine

NCT06848075 | Completed Phase 2 FDA Drug

• 1 other identifier: K-304 P001
• Study Type: interventional
• Target: 431
• Locations: 1 country
• Sites: 66

Brief Summary

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

Conditions

Acute Migraine

Outcome Measures

Primary Outcomes (1)

• Pain freedom

  Assessed using the number of evaluable subjects that report no pain

  2 hours post-dose

Secondary Outcomes (12)

• Freedom from the most bothersome symptom (MBS) (nausea, phonophobia or photophobia)

  2 hours post-dose

• Pain relief

  2 hours post-dose

• Freedom from Photophobia

  2 hours post-dose

• Freedom from Phonophobia

  2 hours post-dose

• Freedom from Nausea

  2 hours post-dose

Study Arms (5)

Elismetrep (K-304) Dose level 1

EXPERIMENTAL

Drug: Elismetrep (K-304) Dose Level 1

Elismetrep (K-304) Dose level 2

EXPERIMENTAL

Drug: Elismetrep (K-304) Dose level 2

Elismetrep (K-304) Dose level 3

EXPERIMENTAL

Drug: Elismetrep (K-304) Dose level 3

Elismetrep (K-304) Dose level 4

EXPERIMENTAL

Drug: Elismetrep (K-304) Dose level 4

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Elismetrep (K-304) Dose Level 1 DRUG

Administered orally

Elismetrep (K-304) Dose level 1

Elismetrep (K-304) Dose level 2 DRUG

Administered orally

Elismetrep (K-304) Dose level 2

Elismetrep (K-304) Dose level 3 DRUG

Administered orally

Elismetrep (K-304) Dose level 3

Elismetrep (K-304) Dose level 4 DRUG

Administered orally

Elismetrep (K-304) Dose level 4

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 70 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 70 years, inclusive, at the time of signing informed consent.
• Patient 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 patient's medical records from his/her treating physician and confirmed by the investigator.
• Patient has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to screening (Visit 1).
• Meet the following requirements:
• Is a male OR
• Is a female who is of non-childbearing potential defined by at least 1 of the following criteria:
• 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.
• Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the subject's recall of their medical history.
• Is a female of reproductive potential and:
• agrees to remain abstinent from heterosexual activity\*
• \*Abstinence can be used as the sole method of contraception if it is in line with the subject'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.
• 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

You may not qualify if:

• 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
• Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches.
• Patient has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than two hours.
• Patient 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).
• Patient has brainstem (a.k.a. basilar-type) or hemiplegic migraine headache, or retinal migraine.
• Patient was \>50 years old at age of first migraine onset.
• Patient 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
• Patient 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. \[Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study\].
• Patient 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, renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases 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.
• Patient 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 (MI), Acute Coronary Syndrome (ACS), percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
• Has a history of human immunodeficiency virus disease.

Sponsors & Collaborators

• Kallyope Inc.: lead

Study Sites (66)

Central Research Associates, LLC (CRA) dba Flourish Research

Birmingham, Alabama, 35205, United States

Location

AMR Mobile

Mobile, Alabama, 36608, United States

Location

Wake Research/ Tucson Neuroscience Research

Tucson, Arizona, 85710, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

WR-PRI, LLC (Encino)

Encino, California, 91316, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

Eximia Research - CA

La Mesa, California, 91942, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

WR-PRI, LLC (Newport Beach)

Newport Beach, California, 92660, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Artemis Institute for Clinical Research - Riverside

Riverside, California, 92503, United States

Location

Acclaim Clinical Research

San Diego, California, 89109, United States

Location

Artemis Institute for Clinical Research - San Diego

San Diego, California, 92103, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Focus Clinical Research

West Hills, California, 91307, United States

Location

CT Clinical Research

Cromwell, Connecticut, 06416, United States

Location

DelRicht Research

Atlanta, Georgia, 30329, United States

Location

Clinical Research Atlanta - Stockbridge

Stockbridge, Georgia, 30281, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Healthcare Research Network II, LLC

Flossmoor, Illinois, 60422, United States

Location

Collective Medical Research

Overland Park, Kansas, 66202, United States

Location

Alliance for Multispecialty Research

Wichita, Kansas, 67207, United States

Location

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

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

DelRicht Research

Gulfport, Mississippi, 39503, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89119, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Dent Neurosciences Research Center

Amherst, New York, 14226, United States

Location

CNY Clinical Research

Manlius, New York, 13104, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Upstate Clinical Research Associates LLC

Williamsville, New York, 14221, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27405, United States

Location

Peters Medical Research

High Point, North Carolina, 27260, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, 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

Yukon, Oklahoma, 73099, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18103, United States

Location

Clinical Research Philadelphia, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States

Location

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States

Location

Atlas-Clinical

West Chester, Pennsylvania, 19380, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

WR-ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

AMR Knoxville (Formerly NOCCR)

Knoxville, Tennessee, 37909, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Donald J Garcia Jr, MD, PA

Austin, Texas, 78737, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75251, United States

Location

Victorium Clinical Research LTD CO

Houston, Texas, 77024, United States

Location

APD Clinical Research

Splendora, Texas, 77372, United States

Location

ClinPoint Trials

Waxahachie, Texas, 75165, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States

Location

Frontier Clinical Research, LLC

Morgantown, West Virginia, 26505, United States

Location

Clinical Investigation Specialist

Kenosha, Wisconsin, 53144, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: February 21, 2025
• First Posted: February 26, 2025
• Study Start: March 5, 2025
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (66)