Recruiting
Phase 3

Elismetrep

Sponsor:

Kallyope Inc.

Code:

NCT07674654

Conditions

Acute Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elismetrep

Placebo

Study Details

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

Study ID

NCT07674654

Start date

Aug 3, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Elismetrep 10 mg

experimental: Elismetrep 20 mg

Interventions

Elismetrep

Administered orally

Placebo

Administered orally

Primary outcome measure

  • Proportion of participants with at least one treatment-emergent adverse event (TEAE) [ Time Frame: Through study completion, an average of 1 year ]
  • Proportion of participants with at least one treatment-emergent serious adverse event (SAE) [ Time Frame: Through study completion, an average of 1 year ]
  • Proportion of participants with TEAEs leading to study drug discontinuation [ Time Frame: 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 [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Annemarie Vance

917-336-3654annemarie@kallyope.com

Locations

Central Research Associates, LLC (CRA) dba Flourish Research

Recruiting

Birmingham, Alabama, United States, 35205

AMR Mobile

Recruiting

Mobile, Alabama, United States, 36608

TrialSphere

Recruiting

Chandler, Arizona, United States, 85286

Arkansas Clinical Research

Recruiting

Little Rock, Arkansas, United States, 72205

Axiom Research, LLC

Recruiting

Colton, California, United States, 92324

ProScience Research Group

Recruiting

Culver City, California, United States, 90230

Leading Edge Research LA, LLC

Recruiting

Encino, California, United States, 91316

Axiom Research, Orange County

Recruiting

Irvine, California, United States, 92604

Downtown L.A. Research Center, Inc.

Recruiting

Los Angeles, California, United States, 90017

Clinical Research Institute

Recruiting

Los Angeles, California, United States, 90048

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

Recruiting

Mission Viejo, California, United States, 92691

Excell Research

Recruiting

Oceanside, California, United States, 92056

Empire Clinical Research

Recruiting

Pomona, California, United States, 91767

The Neurology Group

Recruiting

Pomona, California, United States, 91767

Artemis Institute for Clinical Research

Recruiting

Riverside, California, United States, 92503

Acclaim Clinical Research

Recruiting

San Diego, California, United States, 92120

CenExel Sherman Oaks CA (California Neuroscience Research)

Recruiting

Sherman Oaks, California, United States, 91403

Encompass Clinical Research

Recruiting

Spring Valley, California, United States, 91978

Sunwise Clinical Research

Recruiting

Walnut Creek, California, United States, 94596

Diablo Clinical Research

Recruiting

Walnut Creek, California, United States, 94598

Kinetic Clinical Research

Recruiting

West Covina, California, United States, 91790

Focus Clinical Research

Recruiting

West Hills, California, United States, 91307

IMMUNOe Research Centers

Recruiting

Centennial, Colorado, United States, 80112

MCB Clinical Research Centers

Recruiting

Colorado Springs, Colorado, United States, 80910

Advanced Neurosciences Research

Recruiting

Fort Collins, Colorado, United States, 80528

Chase Medical Research, LLC

Recruiting

Waterbury, Connecticut, United States, 06708

DelRicht Research

Recruiting

Atlanta, Georgia, United States, 30329

Drug Studies America

Recruiting

Marietta, Georgia, United States, 30060

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

Recruiting

Stockbridge, Georgia, United States, 30281

Cedar Crosse Research Center

Recruiting

Chicago, Illinois, United States, 60607

Chicago Headache Center & Research Institute

Recruiting

Chicago, Illinois, United States, 60657

Healthcare Research Network II, LLC

Recruiting

Flossmoor, Illinois, United States, 60447

Chicago Headache Center & Research Institute

Recruiting

Naperville, Illinois, United States, 60563

Integrated Clinical Trials Solution

Recruiting

West Des Moines, Iowa, United States, 50265

Collective Medical Research

Recruiting

Overland Park, Kansas, United States, 66212

Clinical Associates Midwest, LLC

Recruiting

Overland Park, Kansas, United States, 66214

Heartland Research Associates, LLC - An AMR Company

Recruiting

Wichita, Kansas, United States, 67207

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

Recruiting

Bardstown, Kentucky, United States, 40004

AMR Clinical - Lexington

Recruiting

Lexington, Kentucky, United States, 40509

CTI Clinical Research Center

Recruiting

Lexington, Kentucky, United States, 45212

Crescent City Headache & Neurology Center

Recruiting

Chalmette, Louisiana, United States, 70043

DelRicht Research

Recruiting

New Orleans, Louisiana, United States, 70115

Headlands Research - PharmaSite

Recruiting

Pikesville, Maryland, United States, 21208

Boston Clinical Trials - Alcanza

Recruiting

Boston, Massachusetts, United States, 02131

MedVadis Research Corporation, LLC

Recruiting

Waltham, Massachusetts, United States, 02451

Michigan Headache Pain & Neurological Institute

Recruiting

Ann Arbor, Michigan, United States, 48104

Clinical Research Institute

Recruiting

Minneapolis, Minnesota, United States, 55402

DelRicht Research

Recruiting

Gulfport, Mississippi, United States, 39503

Proven Endpoints

Recruiting

Ridgeland, Mississippi, United States, 39157

StudyMetrix Research

Recruiting

City of Saint Peters, Missouri, United States, 63303

Healthcare Research Network

Recruiting

Hazelwood, Missouri, United States, 63042

AMR Clinical - Kansas City

Recruiting

Kansas City, Missouri, United States, 64114

Clinvest Headlands LLC

Recruiting

Springfield, Missouri, United States, 65807

Sundance Clinical Research

Recruiting

St Louis, Missouri, United States, 63141

IMA Clinical Research - Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89102

Excel Clinical Research

Recruiting

Las Vegas, Nevada, United States, 89109

Wake Research Las Vegas Rainbow

Recruiting

Las Vegas, Nevada, United States, 89118

AMR Clinical - Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89119

Redbird Research

Recruiting

Las Vegas, Nevada, United States, 89119

Las Vegas Clinical Trials

Recruiting

North Las Vegas, Nevada, United States, 89030

Advanced Research Institute-Reno

Recruiting

Reno, Nevada, United States, 89511

Albuquerque Clinical Trials

Recruiting

Albuquerque, New Mexico, United States, 87102

Dent Neuro Institute, Buffalo

Recruiting

Amherst, New York, United States, 14226

SPRI Clinical Trials, LLC

Recruiting

Brooklyn, New York, United States, 11235

True North Neurology

Recruiting

Commack, New York, United States, 11725

Central New York Clinical Research

Recruiting

Manlius, New York, United States, 13104

Fieve Clinical Research, Inc

Recruiting

New York, New York, United States, 10017

Rochester Clinical Research

Recruiting

Rochester, New York, United States, 14609

Upstate Clinical Research Associates

Recruiting

Williamsville, New York, United States, 14221

OnSite Clinical Solutions

Recruiting

Charlotte, North Carolina, United States, 28277

Guilford Neurologic Research Partners, LLC

Recruiting

Greensboro, North Carolina, United States, 27405

Headache Wellness Center

Recruiting

Greensboro, North Carolina, United States, 27405

Eximia Research - NC, LLC

Recruiting

Raleigh, North Carolina, United States, 27607

Carolina Research Center, Inc

Recruiting

Shelby, North Carolina, United States, 28150

Hometown Research

Recruiting

Columbus, Ohio, United States, 43228

Hometown Research

Recruiting

Milford, Ohio, United States, 45150

CincyScience

Recruiting

West Chester, Ohio, United States, 45069

OK Clinical Research, LLC

Recruiting

Edmond, Oklahoma, United States, 73034

Hightower Clinical

Recruiting

Oklahoma City, Oklahoma, United States, 73102

DelRicht Research

Recruiting

Tulsa, Oklahoma, United States, 74133

Tekton Research, Inc.

Recruiting

Yukon, Oklahoma, United States, 73099

Summit Research Network

Recruiting

Portland, Oregon, United States, 97210

Advanced Research Institute-Portland

Recruiting

Portland, Oregon, United States, 97223

Lehigh Center for Clinical Research

Recruiting

Allentown, Pennsylvania, United States, 18103

Clinical Research Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Preferred Primary Care Physicians, Inc.

Recruiting

Pittsburgh, Pennsylvania, United States, 15236

Frontier Clinical Research, LLC

Recruiting

Scottdale, Pennsylvania, United States, 15683

Frontier Clinical Research, LLC

Recruiting

Smithfield, Pennsylvania, United States, 15478

Coastal Carolina Research Center

Recruiting

North Charleston, South Carolina, United States, 29405

WR-ClinSearch, LLC

Recruiting

Chattanooga, Tennessee, United States, 37421

Access Clinical Trials Inc

Recruiting

Nashville, Tennessee, United States, 37203

Clinical Research Associates, Inc.

Recruiting

Nashville, Tennessee, United States, 37203

FutureSearch Trials of Neurology

Recruiting

Austin, Texas, United States, 78731

Tekton Research

Recruiting

Austin, Texas, United States, 78745

APD Clinical Research

Recruiting

Cypress, Texas, United States, 77372

Horizon Clinical Research and Gill Neuroscience

Recruiting

Cypress, Texas, United States, 77429

FutureSearch Trials of Dallas, LP

Recruiting

Dallas, Texas, United States, 75251

Victorium Clinical Research

Recruiting

Houston, Texas, United States, 77024

DM Clinical Research

Recruiting

Houston, Texas, United States, 77081

GMG Clinical Research, LLC dba Radiance Clinical Research

Recruiting

Lampasas, Texas, United States, 76550

Aim Trials, LLC

Recruiting

Plano, Texas, United States, 75093

ClinPoint Trials

Recruiting

Waxahachie, Texas, United States, 75165

Pantheon Clinical Research

Recruiting

Bountiful, Utah, United States, 84010

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

Recruiting

Draper, Utah, United States, 84020

Advanced Research Institute

Recruiting

Ogden, Utah, United States, 84405

Granger Medical Clinic

Recruiting

Riverton, Utah, United States, 84096

J. Lewis Research, Inc. / Foothill Family Clinic

Recruiting

Salt Lake City, Utah, United States, 84109

J. Lewis Research, Inc. / Foothill Family Clinic

Recruiting

Salt Lake City, Utah, United States, 84121

Health Research of Hampton Roads, Inc. (HRHR)

Recruiting

Newport News, Virginia, United States, 23606

AMR Clinical - Norfolk

Recruiting

Norfolk, Virginia, United States, 23502

Seattle Clinical Research Center

Recruiting

Seattle, Washington, United States, 98104

Frontier Clinical Research

Recruiting

Morgantown, West Virginia, United States, 26505

Clinical Investigation Specialists, Inc.

Recruiting

Kenosha, Wisconsin, United States, 53144

More Information

Sponsor

Kallyope Inc.

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kallyope Inc. on 2026-08-27.