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NCT07674654PHASE3Recruiting

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

Kallyope Inc.

Start Date

8/3/2026

Completion Date

6/1/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. 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. Note: If a subject treats their qualifying migraine in the base study within 5 days of randomization (i.e. ≤ 4 daily check-ins should have been completed in the eDiary), they are eligible for this study if they missed 1 daily check-in, even though compliance was \<80%; 2. Participant voluntarily agrees to participate in the study by giving written informed consent; 3. Participant is able to read, understand, and complete the study questionnaires and diary; 4. Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions; 5. 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; 6. 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. 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 urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study); 2. 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); 3. 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; 4. Participant is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (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; 5. Has any major surgery scheduled for the duration of the trial; 6. Has any other 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 the interpretation of efficacy and/or safety results; 7. At Visit 1, has an open/ongoing adverse event from the base study EoS visit; 8. Experienced a serious adverse event in the base study; 9. Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.

Interventions

DRUG

Elismetrep

DRUG

Placebo

Interested in This Trial?

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Conditions

Acute Migraine

Locations

Central Research Associates, LLC (CRA) dba Flourish Research

Birmingham, Alabama 35205

United States

AMR Mobile

Mobile, Alabama 36608

United States

TrialSphere

Chandler, Arizona 85286

United States

Arkansas Clinical Research

Little Rock, Arkansas 72205

United States

Axiom Research, LLC

Colton, California 92324

United States

ProScience Research Group

Culver City, California 90230

United States

Leading Edge Research LA, LLC

Encino, California 91316

United States

Axiom Research, Orange County

Irvine, California 92604

United States

Downtown L.A. Research Center, Inc.

Los Angeles, California 90017

United States

Clinical Research Institute

Los Angeles, California 90048

United States

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

Mission Viejo, California 92691

United States

Excell Research

Oceanside, California 92056

United States

Empire Clinical Research

Pomona, California 91767

United States

The Neurology Group

Pomona, California 91767

United States

Artemis Institute for Clinical Research

Riverside, California 92503

United States

Acclaim Clinical Research

San Diego, California 92120

United States

CenExel Sherman Oaks CA (California Neuroscience Research)

Sherman Oaks, California 91403

United States

Encompass Clinical Research

Spring Valley, California 91978

United States

Sunwise Clinical Research

Walnut Creek, California 94596

United States

Diablo Clinical Research

Walnut Creek, California 94598

United States

Kinetic Clinical Research

West Covina, California 91790

United States

Focus Clinical Research

West Hills, California 91307

United States

IMMUNOe Research Centers

Centennial, Colorado 80112

United States

MCB Clinical Research Centers

Colorado Springs, Colorado 80910

United States

Advanced Neurosciences Research

Fort Collins, Colorado 80528

United States

Chase Medical Research, LLC

Waterbury, Connecticut 06708

United States

DelRicht Research

Atlanta, Georgia 30329

United States

Drug Studies America

Marietta, Georgia 30060

United States

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

Stockbridge, Georgia 30281

United States

Cedar Crosse Research Center

Chicago, Illinois 60607

United States

Chicago Headache Center & Research Institute

Chicago, Illinois 60657

United States

Healthcare Research Network II, LLC

Flossmoor, Illinois 60447

United States

Chicago Headache Center & Research Institute

Naperville, Illinois 60563

United States

Integrated Clinical Trials Solution

West Des Moines, Iowa 50265

United States

Collective Medical Research

Overland Park, Kansas 66212

United States

Clinical Associates Midwest, LLC

Overland Park, Kansas 66214

United States

Heartland Research Associates, LLC - An AMR Company

Wichita, Kansas 67207

United States

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

Bardstown, Kentucky 40004

United States

AMR Clinical - Lexington

Lexington, Kentucky 40509

United States

CTI Clinical Research Center

Lexington, Kentucky 45212

United States

Crescent City Headache & Neurology Center

Chalmette, Louisiana 70043

United States

DelRicht Research

New Orleans, Louisiana 70115

United States

Headlands Research - PharmaSite

Pikesville, Maryland 21208

United States

Boston Clinical Trials - Alcanza

Boston, Massachusetts 02131

United States

MedVadis Research Corporation, LLC

Waltham, Massachusetts 02451

United States

Michigan Headache Pain & Neurological Institute

Ann Arbor, Michigan 48104

United States

Clinical Research Institute

Minneapolis, Minnesota 55402

United States

DelRicht Research

Gulfport, Mississippi 39503

United States

Proven Endpoints

Ridgeland, Mississippi 39157

United States

StudyMetrix Research

City of Saint Peters, Missouri 63303

United States

Healthcare Research Network

Hazelwood, Missouri 63042

United States

AMR Clinical - Kansas City

Kansas City, Missouri 64114

United States

Clinvest Headlands LLC

Springfield, Missouri 65807

United States

Sundance Clinical Research

St Louis, Missouri 63141

United States

IMA Clinical Research - Las Vegas

Las Vegas, Nevada 89102

United States

Excel Clinical Research

Las Vegas, Nevada 89109

United States

Wake Research Las Vegas Rainbow

Las Vegas, Nevada 89118

United States

AMR Clinical - Las Vegas

Las Vegas, Nevada 89119

United States

Redbird Research

Las Vegas, Nevada 89119

United States

Las Vegas Clinical Trials

North Las Vegas, Nevada 89030

United States

Advanced Research Institute-Reno

Reno, Nevada 89511

United States

Albuquerque Clinical Trials

Albuquerque, New Mexico 87102

United States

Dent Neuro Institute, Buffalo

Amherst, New York 14226

United States

SPRI Clinical Trials, LLC

Brooklyn, New York 11235

United States

True North Neurology

Commack, New York 11725

United States

Central New York Clinical Research

Manlius, New York 13104

United States

Fieve Clinical Research, Inc

New York, New York 10017

United States

Rochester Clinical Research

Rochester, New York 14609

United States

Upstate Clinical Research Associates

Williamsville, New York 14221

United States

OnSite Clinical Solutions

Charlotte, North Carolina 28277

United States

Guilford Neurologic Research Partners, LLC

Greensboro, North Carolina 27405

United States

Headache Wellness Center

Greensboro, North Carolina 27405

United States

Eximia Research - NC, LLC

Raleigh, North Carolina 27607

United States

Carolina Research Center, Inc

Shelby, North Carolina 28150

United States

Hometown Research

Columbus, Ohio 43228

United States

Hometown Research

Milford, Ohio 45150

United States

CincyScience

West Chester, Ohio 45069

United States

OK Clinical Research, LLC

Edmond, Oklahoma 73034

United States

Hightower Clinical

Oklahoma City, Oklahoma 73102

United States

DelRicht Research

Tulsa, Oklahoma 74133

United States

Tekton Research, Inc.

Yukon, Oklahoma 73099

United States

Summit Research Network

Portland, Oregon 97210

United States

Advanced Research Institute-Portland

Portland, Oregon 97223

United States

Lehigh Center for Clinical Research

Allentown, Pennsylvania 18103

United States

Clinical Research Philadelphia

Philadelphia, Pennsylvania 19114

United States

Preferred Primary Care Physicians, Inc.

Pittsburgh, Pennsylvania 15236

United States

Frontier Clinical Research, LLC

Scottdale, Pennsylvania 15683

United States

Frontier Clinical Research, LLC

Smithfield, Pennsylvania 15478

United States

Coastal Carolina Research Center

North Charleston, South Carolina 29405

United States

WR-ClinSearch, LLC

Chattanooga, Tennessee 37421

United States

Access Clinical Trials Inc

Nashville, Tennessee 37203

United States

Clinical Research Associates, Inc.

Nashville, Tennessee 37203

United States

FutureSearch Trials of Neurology

Austin, Texas 78731

United States

Tekton Research

Austin, Texas 78745

United States

APD Clinical Research

Cypress, Texas 77372

United States

Horizon Clinical Research and Gill Neuroscience

Cypress, Texas 77429

United States

FutureSearch Trials of Dallas, LP

Dallas, Texas 75251

United States

Victorium Clinical Research

Houston, Texas 77024

United States

DM Clinical Research

Houston, Texas 77081

United States

GMG Clinical Research, LLC dba Radiance Clinical Research

Lampasas, Texas 76550

United States

Aim Trials, LLC

Plano, Texas 75093

United States

ClinPoint Trials

Waxahachie, Texas 75165

United States

Pantheon Clinical Research

Bountiful, Utah 84010

United States

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

Draper, Utah 84020

United States

Advanced Research Institute

Ogden, Utah 84405

United States

Granger Medical Clinic

Riverton, Utah 84096

United States

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah 84109

United States

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah 84121

United States

Health Research of Hampton Roads, Inc. (HRHR)

Newport News, Virginia 23606

United States

AMR Clinical - Norfolk

Norfolk, Virginia 23502

United States

Seattle Clinical Research Center

Seattle, Washington 98104

United States

Frontier Clinical Research

Morgantown, West Virginia 26505

United States

Clinical Investigation Specialists, Inc.

Kenosha, Wisconsin 53144

United States