A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Kallyope Inc.
- Study ID
- NCT07645924
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Elismetrep — DRUGAdministered orally
- Placebo — DRUGAdministered orally
Study Details
This is a double-blind, randomized, multicenter, outpatient evaluation of the efficacy, safety, and tolerability of elismetrep, as compared with placebo, in the acute treatment of migraine.
Key Dates
- Start date
- Jul 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Feb 28, 2027
- Completion
- Feb 28, 2027
Study Design
- Enrollment
- 1,800 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Elismetrep 10 mg
- Experimental: Elismetrep 20 mg
- Placebo Comparator: Placebo
Primary Outcome Measure
Pain freedom at 2 hours post-dose [ Time Frame: Two hours post-dose ]
Central Contacts
- Annemarie Vance917-336-3654
Locations (119)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Central Research Associates, LLC (CRA) dba Flourish Research | Birmingham | Alabama | 35205 | (205) 327-1077 |
| AMR Mobile | Mobile | Alabama | 36608 | (251) 901-2127 |
| TrialSphere | Chandler | Arizona | 85286 | (623) 267-8314 |
| Arkansas Clinical Research | Little Rock | Arkansas | 72205 | (501) 480-5088 |
| Axiom Research, LLC | Colton | California | 92324 | (909) 824-2325 |
| ProScience Research Group | Culver City | California | 90230 | (424) 227-8127 |
| Leading Edge Research LA, LLC | Encino | California | 91316 | (818) 578-4555 |
| Axiom Research, Orange County | Irvine | California | 92604 | (909) 824-2325 |
| Clinical Research Institute | Los Angeles | California | 90048 | (323) 879-9999 |
| Downtown L.A. Research Center, Inc. | Los Angeles | California | 90017 | (213) 261-3680 |
| M3 Wake Research - Mission Mental Health (WR-MMH) | Mission Viejo | California | 92691 | (949) 752-7910 |
| Excell Research | Oceanside | California | 92056 | (760) 758-2222 |
| Empire Clinical Research | Pomona | California | 91767 | (909) 981-5321 |
| The Neurology Group | Pomona | California | 91767 | (909) 982-2719 |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | (855) 367-8834 |
| Acclaim Clinical Research | San Diego | California | 92120 | (855) 367-8834 |
| CenExel Sherman Oaks CA (California Neuroscience Research) | Sherman Oaks | California | 91403 | (818) 990-2671 |
| Encompass Clinical Research | Spring Valley | California | 91978 | (619) 660-9068 |
| Diablo Clinical Research | Walnut Creek | California | 94598 | (925) 930-7267 |
| Sunwise Clinical Research | Walnut Creek | California | 94596 | (925) 298-5147 |
| Kinetic Clinical Research | West Covina | California | 91790 | (657) 230-7120 |
| Focus Clinical Research | West Hills | California | 91307 | (818) 253-8966 |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | (303) 771-9000 |
| MCB Clinical Research Centers | Colorado Springs | Colorado | 80910 | (719) 634-6576 |
| Advanced Neurosciences Research | Fort Collins | Colorado | 80528 | (970) 226-6111 |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | (203) 419-4404 |
| DelRicht Research | Atlanta | Georgia | 30329 | (770) 417-4454 |
| Drug Studies America | Marietta | Georgia | 30060 | (678) 581-5252 |
| Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge | Stockbridge | Georgia | 30281 | (770) 626-0177 |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | (312) 431-6780 |
| Chicago Headache Center & Research Institute | Chicago | Illinois | 60657 | (773) 935-1000 |
| Healthcare Research Network II, LLC | Flossmoor | Illinois | 60477 | (708) 388-2245 |
| Chicago Headache Center & Research Institute | Naperville | Illinois | 60563 | (415) 397-0700 |
| Integrated Clinical Trials Solution | West Des Moines | Iowa | 50265 | (515) 223-2300 |
| Clinical Associates Midwest, LLC | Overland Park | Kansas | 66214 | (913) 359-5699 |
| Collective Medical Research | Overland Park | Kansas | 66212 | (913) 381-7180 |
| Heartland Research Associates, LLC - An AMR Company | Wichita | Kansas | 67207 | (316) 689-6635 |
| Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research) | Bardstown | Kentucky | 40004 | (502) 349-1569 |
| AMR Clinical - Lexington | Lexington | Kentucky | 40509 | (859) 264-8999 |
| CTI Clinical Research Center | Lexington | Kentucky | 45212 | (513) 721-3868 |
| Monroe Biomedical Research (former L-MARC Research Center) | Louisville | Kentucky | 40213 | (502) 305-1010 |
| Crescent City Headache & Neurology Center | Chalmette | Louisiana | 70043 | (504) 418-6040 |
| DelRicht Research | New Orleans | Louisiana | 70115 | (504) 336-2667 |
| Headlands Research - PharmaSite | Pikesville | Maryland | 21208 | (410) 602-1440 |
| Boston Clinical Trials - Alcanza | Boston | Massachusetts | 02131 | (843) 856-3784 |
| MedVadis Research Corporation, LLC | Waltham | Massachusetts | 02451 | (781) 373-2940 |
| Michigan Headache Pain & Neurological Institute | Ann Arbor | Michigan | 48104 | (734) 677-6000 |
| Minneapolis Clinic of Neurology | Burnsville | Minnesota | 55337 | (763) 302-4162 |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | (612) 333-2200 |
| DelRicht Research | Gulfport | Mississippi | 39503 | (228) 588-8268 |
| Proven Endpoints | Ridgeland | Mississippi | 39157 | (601) 790-1811 |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | (636) 387-5100 |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | (314) 972-9600 |
| AMR Clinical - Kansas City | Kansas City | Missouri | 64114 | (816) 643-4153 |
| Clinvest Headlands LLC | Springfield | Missouri | 65807 | (417) 883-7889 |
| Sundance Clinical Research | St Louis | Missouri | 63141 | (314) 567-3377 |
| AMR Clinical - Las Vegas | Las Vegas | Nevada | 89119 | (702) 529-0153 |
| Excel Clinical Research | Las Vegas | Nevada | 89109 | (702) 680-1500 |
| IMA Clinical Research - Las Vegas | Las Vegas | Nevada | 89102 | (702) 527-7401 |
| Redbird Research | Las Vegas | Nevada | 89119 | (702) 577-2000 |
| Wake Research Las Vegas Rainbow | Las Vegas | Nevada | 89118 | (702) 893-8968 |
| Las Vegas Clinical Trials | North Las Vegas | Nevada | 89030 | (702) 637-3223 |
| Advanced Research Institute - Reno | Reno | Nevada | 89511 | (775) 502-1616 |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | (505) 224-7407 |
| Dent Neuro Institute, Buffalo | Amherst | New York | 14226 | (716) 250-2017 |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | (646) 747-4060 |
| True North Neurology | Commack | New York | 11725 | (631) 364-9119 |
| Central New York Clinical Research | Manlius | New York | 13104 | (315) 682-3263 |
| Fieve Clinical Research, Inc | New York | New York | 10017 | (212) 772-3570 |
| Rochester Clinical Research | Rochester | New York | 14609 | (585) 288-0890 |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | (716) 626-6320 |
| OnSite Clinical Solutions | Charlotte | North Carolina | 28277 | (800) 785-3150 |
| Guildford Neurologic Research Partners, LLC | Greensboro | North Carolina | 27405 | (336) 516-9103 |
| Headache Wellness Center | Greensboro | North Carolina | 27405 | (336) 574-8000 |
| Eximia Research - NC, LLC | Raleigh | North Carolina | 27607 | (919) 800-5154 |
| Carolina Research Center, Inc | Shelby | North Carolina | 28150 | (704) 487-5228 |
| Hometown Research | Columbus | Ohio | 43228 | (614) 362-3980 |
| Hometown Research | Huber Heights | Ohio | 45424 | (937) 912-4364 |
| Hometown Research | Milford | Ohio | 45150 | (513) 831-5900 |
| CincyScience | West Chester | Ohio | 45069 | (513) 646-4864 |
| OK Clinical Research, LLC | Edmond | Oklahoma | 73034 | (405) 285-6811 |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | (405) 479-8331 |
| DelRicht Research | Tulsa | Oklahoma | 74133 | (918) 932-2276 |
| Tekton Research, Inc. | Yukon | Oklahoma | 73099 | (405) 281-3433 |
| Advanced Research Institute - Portland | Portland | Oregon | 97223 | (503) 610-0033 |
| Summit Research Network | Portland | Oregon | 97210 | (855) 367-8834 |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18103 | (818) 578-4555 |
| Clinical Research Philadelphia | Philadelphia | Pennsylvania | 19114 | (215) 676-6696 |
| Preferred Primary Care Physicians, Inc. | Pittsburgh | Pennsylvania | 15236 | (412) 650-6155 |
| Frontier Clinical Research, LLC | Scottdale | Pennsylvania | 15683 | (724) 220-5281 |
| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | 15478 | (724) 569-8036 |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | (843) 856-3784 |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | (423) 698-4584 |
| Access Clinical Trials, Inc | Nashville | Tennessee | 37203 | (615) 320-6076 |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | (615) 329-0197 |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | (512) 380-9925 |
| Tekton Research | Austin | Texas | 78745 | (512) 859-3834 |
| APD Clinical Research | Cypress | Texas | 77372 | (281) 315-4986 |
| Horizon Clinical Research and Gill Neuroscience | Cypress | Texas | 77429 | (949) 491-0710 |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75251 | (214) 361-7700 |
| Relaro Medical Trials, LLC | Dallas | Texas | 75243 | (469) 730-3282 |
| Helios CR, Inc. - Fort Worth | Fort Worth | Texas | 76104 | (817) 348-0228 |
| DM Clinical Research | Houston | Texas | 77081 | (346) 550-9559 |
| Victorium Clinical Research | Houston | Texas | 77024 | (832) 203-7026 |
| Helios CR, Inc. - Keller | Keller | Texas | 76248 | (682) 774-8013 |
| GMG Clinical Research, LLC dba Radiance Clinical Research | Lampasas | Texas | 76550 | (512) 556-4130 |
| Aim Trials, LLC | Plano | Texas | 75093 | (214) 856-2778 |
| Clinpoint Trials | Waxahachie | Texas | 75165 | (972) 937-1640 |
| Pantheon Clinical Research | Bountiful | Utah | 84010 | (385) 281-0550 |
| J. Lewis Research, Inc. / Foothill Family Clinic Draper | Draper | Utah | 84020 | (801) 365-1032 |
| Advanced Research Institute | Ogden | Utah | 84405 | (801) 409-2040 |
| Granger Medical Clinic | Riverton | Utah | 84096 | (801) 302-1769 |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84109 | (801) 486-3021 |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84121 | (801) 365-1032 |
| Health Research of Hampton Roads, Inc. (HRHR) | Newport News | Virginia | 23606 | (757) 591-8100 |
| AMR Clinical - Norfolk | Norfolk | Virginia | 23502 | (757) 614-1001 |
| Seattle Clinical Research Center | Seattle | Washington | 98104 | (206) 522-3330 |
| Frontier Clinical Research | Morgantown | West Virginia | 26505 | (304) 241-1648 |
| Clinical Investigation Specialists, Inc. | Kenosha | Wisconsin | 53144 | (847) 406-8080 |
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