A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine

NCT07674654 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: K-304 P005
• Study Type: interventional
• Target: 1,000
• Locations: 2 countries
• Sites: 115

Brief Summary

This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.

Conditions

Acute Migraine

Outcome Measures

Primary Outcomes (4)

• Proportion of participants with at least one treatment-emergent adverse event (TEAE)

  Through study completion, an average of 1 year

• Proportion of participants with at least one treatment-emergent serious adverse event (SAE)

  Through study completion, an average of 1 year

• Proportion of participants with TEAEs leading to study drug discontinuation

  Through study completion, an average of 1 year

• Proportion of participants with TEAEs that occur in at least 5% of treated participants in either treatment arm

  Through study completion, an average of 1 year

Study Arms (2)

Elismetrep 10 mg

EXPERIMENTAL

Drug: Elismetrep; Drug: Placebo

Elismetrep 20 mg

EXPERIMENTAL

Drug: Elismetrep

Interventions

Elismetrep DRUG

Administered orally

Also known as: K-304

Elismetrep 10 mg; Elismetrep 20 mg

Placebo DRUG

Administered orally

Elismetrep 10 mg

Eligibility Criteria

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

You may qualify if:

• 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;
• Participant voluntarily agrees to participate in the study by giving written informed consent;
• Participant is able to read, understand, and complete the study questionnaires and diary;
• Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;
• 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;
• 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.

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 urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study);
• 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);
• 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;
• Participant 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 trial participation) as assessed for the base study E0S/Visit 3;
• Has any major surgery scheduled for the duration of the trial;
• At Visit 1, has an open/ongoing adverse event from the base study EoS visit;
• Experienced a serious adverse event in the base study;
• Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.

Sponsors & Collaborators

• Kallyope Inc.: lead

Study Sites (115)

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, 60447, 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

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

Guilford 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

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

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75251, United States

Location

Victorium Clinical Research

Houston, Texas, 77024, United States

Location

DM Clinical Research

Houston, Texas, 77081, 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

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 15, 2026
• First Posted: June 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (114)