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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Elismetrep

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Annemarie Vance; Phone Number: 917-336-3654; Email: annemarie@kallyope.com

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00907
    • Solace Clinical Research
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates, LLC (CRA) dba Flourish Research
    • Mobile, Alabama, United States, 36608
      • AMR Mobile
  • Arizona
    • Chandler, Arizona, United States, 85286
      • TrialSphere
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Clinical Research
  • California
    • Colton, California, United States, 92324
      • Axiom Research, LLC
    • Culver City, California, United States, 90230
      • ProScience Research Group
    • Encino, California, United States, 91316
      • Leading Edge Research LA, LLC
    • Irvine, California, United States, 92604
      • Axiom Research, Orange County
    • Los Angeles, California, United States, 90048
      • Clinical Research Institute
    • Los Angeles, California, United States, 90017
      • Downtown L.A. Research Center, Inc.
    • Mission Viejo, California, United States, 92691
      • M3 Wake Research - Mission Mental Health (WR-MMH)
    • Oceanside, California, United States, 92056
      • Excell Research
    • Pomona, California, United States, 91767
      • The Neurology Group
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • Riverside, California, United States, 92503
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research
    • Sherman Oaks, California, United States, 91403
      • CenExel Sherman Oaks CA (California Neuroscience Research)
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
    • Walnut Creek, California, United States, 94596
      • Sunwise Clinical Research
    • West Covina, California, United States, 91790
      • Kinetic Clinical Research
    • West Hills, California, United States, 91307
      • Focus Clinical Research
  • Colorado
    • Centennial, Colorado, United States, 80112
      • IMMUNOe Research Centers
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • DelRicht Research
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
    • Stockbridge, Georgia, United States, 30281
      • Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center
    • Chicago, Illinois, United States, 60657
      • Chicago Headache Center & Research Institute
    • Flossmoor, Illinois, United States, 60447
      • Healthcare Research Network II, LLC
    • Naperville, Illinois, United States, 60563
      • Chicago Headache Center & Research Institute
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trials Solution
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Collective Medical Research
    • Overland Park, Kansas, United States, 66214
      • Clinical Associates Midwest, LLC
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC - An AMR Company
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
    • Lexington, Kentucky, United States, 40509
      • AMR Clinical - Lexington
    • Lexington, Kentucky, United States, 45212
      • CTI Clinical Research Center
    • Louisville, Kentucky, United States, 40213
      • Monroe Biomedical Research (former L-MARC Research Center)
  • Louisiana
    • Chalmette, Louisiana, United States, 70043
      • Crescent City Headache & Neurology Center
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
  • Maryland
    • Pikesville, Maryland, United States, 21208
      • Headlands Research - PharmaSite
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials - Alcanza
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research Corporation, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Headache Pain & Neurological Institute
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Minneapolis Clinic of Neurology
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • DelRicht Research
    • Ridgeland, Mississippi, United States, 39157
      • Proven Endpoints
  • Missouri
    • City of Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research
    • Hazelwood, Missouri, United States, 63042
      • Healthcare Research Network
    • Kansas City, Missouri, United States, 64114
      • AMR Clinical - Kansas City
    • Springfield, Missouri, United States, 65807
      • Clinvest Headlands LLC
    • St Louis, Missouri, United States, 63141
      • Sundance Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
    • Las Vegas, Nevada, United States, 89119
      • Redbird Research
    • Las Vegas, Nevada, United States, 89102
      • IMA Clinical Research - Las Vegas
    • Las Vegas, Nevada, United States, 89119
      • AMR Clinical - Las Vegas
    • Las Vegas, Nevada, United States, 89118
      • Wake Research Las Vegas Rainbow
    • North Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
    • Reno, Nevada, United States, 89511
      • Advanced Research Institute-Reno
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neuro Institute, Buffalo
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, LLC
    • Commack, New York, United States, 11725
      • True North Neurology
    • Manlius, New York, United States, 13104
      • Central New York Clinical Research
    • New York, New York, United States, 10017
      • Fieve Clinical Research, Inc
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • OnSite Clinical Solutions
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center
    • Greensboro, North Carolina, United States, 27405
      • Guilford Neurologic Research Partners, LLC
    • Raleigh, North Carolina, United States, 27607
      • Eximia Research - NC, LLC
    • Shelby, North Carolina, United States, 28150
      • Carolina Research Center, Inc
  • Ohio
    • Columbus, Ohio, United States, 43228
      • Hometown Research
    • Huber Heights, Ohio, United States, 45424
      • Hometown Research
    • Milford, Ohio, United States, 45150
      • Hometown Research
    • West Chester, Ohio, United States, 45069
      • CincyScience
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research, LLC
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical
    • Tulsa, Oklahoma, United States, 74133
      • DelRicht Research
    • Yukon, Oklahoma, United States, 73099
      • Tekton Research, Inc.
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network
    • Portland, Oregon, United States, 97223
      • Advanced Research Institute-Portland
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Center for Clinical Research
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians, Inc.
    • Scottdale, Pennsylvania, United States, 15683
      • Frontier Clinical Research, LLC
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, LLC
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-ClinSearch, LLC
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
    • Nashville, Tennessee, United States, 37203
      • Access Clinical Trials Inc
  • Texas
    • Austin, Texas, United States, 78731
      • Futuresearch Trials Of Neurology
    • Austin, Texas, United States, 78745
      • Tekton Research
    • Cypress, Texas, United States, 77372
      • APD Clinical Research
    • Cypress, Texas, United States, 77429
      • Horizon Clinical Research and Gill Neuroscience
    • Dallas, Texas, United States, 75243
      • Relaro Medical Trials, LLC
    • Dallas, Texas, United States, 75251
      • FutureSearch Trials of Dallas, LP
    • Fort Worth, Texas, United States, 76104
      • Helios CR, Inc. - Fort Worth
    • Houston, Texas, United States, 77024
      • Victorium Clinical Research
    • Houston, Texas, United States, 77081
      • DM Clinical Research
    • Keller, Texas, United States, 76248
      • Helios CR, Inc. - Keller
    • Lampasas, Texas, United States, 76550
      • GMG Clinical Research, LLC dba Radiance Clinical Research
    • Plano, Texas, United States, 75093
      • Aim Trials, LLC
    • Waxahachie, Texas, United States, 75165
      • ClinPoint Trials
  • Utah
    • Bountiful, Utah, United States, 84010
      • Pantheon Clinical Research
    • Draper, Utah, United States, 84020
      • J. Lewis Research, Inc. / Foothill Family Clinic Draper
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
    • Riverton, Utah, United States, 84096
      • Granger Medical Clinic
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc. / Foothill Family Clinic
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc. / Foothill Family Clinic
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads, Inc. (HRHR)
    • Norfolk, Virginia, United States, 23502
      • AMR Clinical - Norfolk
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle Clinical Research Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Frontier Clinical Research
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Clinical Investigation Specialists, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;
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 (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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elismetrep 10 mg	Drug: Placebo; Administered orally; Drug: Elismetrep; Administered orally; Other Names: K-304
Experimental: Elismetrep 20 mg	Drug: Elismetrep; Administered orally; Other Names: K-304

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kallyope Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: K-304 P005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No