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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elismetrep 10 mg | Experimental |
| |
| Elismetrep 20 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elismetrep | Drug | Administered orally |
|
| Measure | Description | 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 |
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Inclusion Criteria:
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).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annemarie Vance | Contact | 917-336-3654 | annemarie@kallyope.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates, LLC (CRA) dba Flourish Research | Birmingham | Alabama | 35205 | United States | ||
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| Placebo | Drug | Administered orally |
|
| 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 |
| Monroe Biomedical Research (former L-MARC Research Center) | Louisville | Kentucky | 40213 | 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 |
| Solace Clinical Research | San Juan | 00907 | Puerto Rico |