A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
26 août 2026 mis à jour par: Kallyope Inc.
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
1000
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Annemarie Vance
- Numéro de téléphone: 917-336-3654
- E-mail: annemarie@kallyope.com
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35205
- Recrutement
- Central Research Associates, LLC (CRA) dba Flourish Research
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Mobile, Alabama, États-Unis, 36608
- Recrutement
- AMR Mobile
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Arizona
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Chandler, Arizona, États-Unis, 85286
- Recrutement
- TrialSphere
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- Recrutement
- Arkansas Clinical Research
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California
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Colton, California, États-Unis, 92324
- Recrutement
- Axiom Research, LLC
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Culver City, California, États-Unis, 90230
- Recrutement
- Proscience Research Group
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Encino, California, États-Unis, 91316
- Recrutement
- Leading Edge Research LA, LLC
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Irvine, California, États-Unis, 92604
- Recrutement
- Axiom Research, Orange County
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Los Angeles, California, États-Unis, 90048
- Recrutement
- Clinical Research Institute
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Los Angeles, California, États-Unis, 90017
- Recrutement
- Downtown L.A. Research Center, Inc.
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Mission Viejo, California, États-Unis, 92691
- Recrutement
- M3 Wake Research - Mission Mental Health (WR-MMH)
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Oceanside, California, États-Unis, 92056
- Recrutement
- Excell Research
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Pomona, California, États-Unis, 91767
- Recrutement
- The Neurology Group
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Pomona, California, États-Unis, 91767
- Recrutement
- Empire Clinical Research
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Riverside, California, États-Unis, 92503
- Recrutement
- Artemis Institute for Clinical Research
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San Diego, California, États-Unis, 92120
- Recrutement
- Acclaim Clinical Research
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Sherman Oaks, California, États-Unis, 91403
- Recrutement
- CenExel Sherman Oaks CA (California Neuroscience Research)
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Spring Valley, California, États-Unis, 91978
- Recrutement
- Encompass Clinical Research
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Walnut Creek, California, États-Unis, 94598
- Recrutement
- Diablo Clinical Research
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Walnut Creek, California, États-Unis, 94596
- Recrutement
- Sunwise Clinical Research
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West Covina, California, États-Unis, 91790
- Recrutement
- Kinetic Clinical Research
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West Hills, California, États-Unis, 91307
- Recrutement
- Focus Clinical Research
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Colorado
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Centennial, Colorado, États-Unis, 80112
- Recrutement
- IMMUNOe Research Centers
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Colorado Springs, Colorado, États-Unis, 80910
- Recrutement
- MCB Clinical Research Centers
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Fort Collins, Colorado, États-Unis, 80528
- Recrutement
- Advanced Neurosciences Research
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Connecticut
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Waterbury, Connecticut, États-Unis, 06708
- Recrutement
- Chase Medical Research, LLC
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Georgia
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Atlanta, Georgia, États-Unis, 30329
- Recrutement
- DelRicht Research
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Marietta, Georgia, États-Unis, 30060
- Recrutement
- Drug Studies America
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Stockbridge, Georgia, États-Unis, 30281
- Recrutement
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
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Illinois
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Chicago, Illinois, États-Unis, 60607
- Recrutement
- Cedar Crosse Research Center
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Chicago, Illinois, États-Unis, 60657
- Recrutement
- Chicago Headache Center & Research Institute
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Flossmoor, Illinois, États-Unis, 60447
- Recrutement
- Healthcare Research Network II, LLC
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Naperville, Illinois, États-Unis, 60563
- Recrutement
- Chicago Headache Center & Research Institute
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Iowa
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West Des Moines, Iowa, États-Unis, 50265
- Recrutement
- Integrated Clinical Trials Solution
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Kansas
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Overland Park, Kansas, États-Unis, 66214
- Recrutement
- Clinical Associates Midwest, LLC
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Overland Park, Kansas, États-Unis, 66212
- Recrutement
- Collective Medical Research
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Wichita, Kansas, États-Unis, 67207
- Recrutement
- Heartland Research Associates, LLC - An AMR Company
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Kentucky
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Bardstown, Kentucky, États-Unis, 40004
- Recrutement
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
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Lexington, Kentucky, États-Unis, 40509
- Recrutement
- AMR Clinical - Lexington
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Lexington, Kentucky, États-Unis, 45212
- Recrutement
- CTI Clinical Research Center
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Louisiana
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Chalmette, Louisiana, États-Unis, 70043
- Recrutement
- Crescent City Headache & Neurology Center
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New Orleans, Louisiana, États-Unis, 70115
- Recrutement
- DelRicht Research
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Maryland
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Pikesville, Maryland, États-Unis, 21208
- Recrutement
- Headlands Research - Pharmasite
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Massachusetts
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Boston, Massachusetts, États-Unis, 02131
- Recrutement
- Boston Clinical Trials - Alcanza
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Waltham, Massachusetts, États-Unis, 02451
- Recrutement
- MedVadis Research Corporation, LLC
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Michigan
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Ann Arbor, Michigan, États-Unis, 48104
- Recrutement
- Michigan Headache Pain & Neurological Institute
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55402
- Recrutement
- Clinical Research Institute
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Mississippi
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Gulfport, Mississippi, États-Unis, 39503
- Recrutement
- DelRicht Research
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Ridgeland, Mississippi, États-Unis, 39157
- Recrutement
- Proven Endpoints
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Missouri
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City of Saint Peters, Missouri, États-Unis, 63303
- Recrutement
- StudyMetrix Research
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Hazelwood, Missouri, États-Unis, 63042
- Recrutement
- Healthcare Research Network
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Kansas City, Missouri, États-Unis, 64114
- Recrutement
- AMR Clinical - Kansas City
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Springfield, Missouri, États-Unis, 65807
- Recrutement
- Clinvest Headlands Llc
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St Louis, Missouri, États-Unis, 63141
- Recrutement
- Sundance Clinical Research
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Nevada
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Las Vegas, Nevada, États-Unis, 89109
- Recrutement
- Excel Clinical Research
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Las Vegas, Nevada, États-Unis, 89119
- Recrutement
- Redbird Research
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Las Vegas, Nevada, États-Unis, 89102
- Recrutement
- Ima Clinical Research - Las Vegas
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Las Vegas, Nevada, États-Unis, 89118
- Recrutement
- Wake Research Las Vegas Rainbow
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Las Vegas, Nevada, États-Unis, 89119
- Recrutement
- AMR Clinical - Las Vegas
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North Las Vegas, Nevada, États-Unis, 89030
- Recrutement
- Las Vegas Clinical Trials
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Reno, Nevada, États-Unis, 89511
- Recrutement
- Advanced Research Institute-Reno
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87102
- Recrutement
- Albuquerque Clinical Trials
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New York
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Amherst, New York, États-Unis, 14226
- Recrutement
- Dent Neuro Institute, Buffalo
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Brooklyn, New York, États-Unis, 11235
- Recrutement
- SPRI Clinical Trials, LLC
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Commack, New York, États-Unis, 11725
- Recrutement
- True North Neurology
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Manlius, New York, États-Unis, 13104
- Recrutement
- Central New York Clinical Research
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New York, New York, États-Unis, 10017
- Recrutement
- Fieve Clinical Research, Inc
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Rochester, New York, États-Unis, 14609
- Recrutement
- Rochester Clinical Research
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Williamsville, New York, États-Unis, 14221
- Recrutement
- Upstate Clinical Research Associates
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North Carolina
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Charlotte, North Carolina, États-Unis, 28277
- Recrutement
- Onsite Clinical Solutions
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Greensboro, North Carolina, États-Unis, 27405
- Recrutement
- Headache Wellness Center
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Greensboro, North Carolina, États-Unis, 27405
- Recrutement
- Guilford Neurologic Research Partners, LLC
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Raleigh, North Carolina, États-Unis, 27607
- Recrutement
- Eximia Research - NC, LLC
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Shelby, North Carolina, États-Unis, 28150
- Recrutement
- Carolina Research Center, Inc
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Ohio
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Columbus, Ohio, États-Unis, 43228
- Recrutement
- Hometown Research
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Milford, Ohio, États-Unis, 45150
- Recrutement
- Hometown Research
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West Chester, Ohio, États-Unis, 45069
- Recrutement
- CincyScience
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Oklahoma
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Edmond, Oklahoma, États-Unis, 73034
- Recrutement
- OK Clinical Research, LLC
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Oklahoma City, Oklahoma, États-Unis, 73102
- Recrutement
- Hightower Clinical
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Tulsa, Oklahoma, États-Unis, 74133
- Recrutement
- DelRicht Research
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Yukon, Oklahoma, États-Unis, 73099
- Recrutement
- Tekton Research, Inc.
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Oregon
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Portland, Oregon, États-Unis, 97210
- Recrutement
- Summit Research Network
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Portland, Oregon, États-Unis, 97223
- Recrutement
- Advanced Research Institute-Portland
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Pennsylvania
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Allentown, Pennsylvania, États-Unis, 18103
- Recrutement
- Lehigh Center For Clinical Research
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Philadelphia, Pennsylvania, États-Unis, 19114
- Recrutement
- Clinical Research Philadelphia
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Pittsburgh, Pennsylvania, États-Unis, 15236
- Recrutement
- Preferred Primary Care Physicians, Inc.
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Scottdale, Pennsylvania, États-Unis, 15683
- Recrutement
- Frontier Clinical Research, LLC
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Smithfield, Pennsylvania, États-Unis, 15478
- Recrutement
- Frontier Clinical Research, LLC
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South Carolina
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North Charleston, South Carolina, États-Unis, 29405
- Recrutement
- Coastal Carolina Research Center
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37421
- Recrutement
- WR-ClinSearch, LLC
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- Clinical Research Associates, Inc.
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- Access Clinical Trials Inc
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Texas
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Austin, Texas, États-Unis, 78731
- Recrutement
- FutureSearch Trials of Neurology
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Austin, Texas, États-Unis, 78745
- Recrutement
- Tekton Research
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Cypress, Texas, États-Unis, 77372
- Recrutement
- APD Clinical Research
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Cypress, Texas, États-Unis, 77429
- Recrutement
- Horizon Clinical Research and Gill Neuroscience
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Dallas, Texas, États-Unis, 75251
- Recrutement
- FutureSearch Trials of Dallas, LP
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Houston, Texas, États-Unis, 77081
- Recrutement
- DM Clinical Research
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Houston, Texas, États-Unis, 77024
- Recrutement
- Victorium Clinical Research
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Lampasas, Texas, États-Unis, 76550
- Recrutement
- GMG Clinical Research, LLC dba Radiance Clinical Research
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Plano, Texas, États-Unis, 75093
- Recrutement
- AIM Trials, LLC
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Waxahachie, Texas, États-Unis, 75165
- Recrutement
- ClinPoint Trials
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Utah
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Bountiful, Utah, États-Unis, 84010
- Recrutement
- Pantheon Clinical Research
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Draper, Utah, États-Unis, 84020
- Recrutement
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
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Ogden, Utah, États-Unis, 84405
- Recrutement
- Advanced Research Institute
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Riverton, Utah, États-Unis, 84096
- Recrutement
- Granger Medical Clinic
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Salt Lake City, Utah, États-Unis, 84109
- Recrutement
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, États-Unis, 84121
- Recrutement
- J. Lewis Research, Inc. / Foothill Family Clinic
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Virginia
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Newport News, Virginia, États-Unis, 23606
- Recrutement
- Health Research of Hampton Roads, Inc. (HRHR)
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Norfolk, Virginia, États-Unis, 23502
- Recrutement
- AMR Clinical - Norfolk
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Washington
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Seattle, Washington, États-Unis, 98104
- Recrutement
- Seattle Clinical Research Center
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West Virginia
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Morgantown, West Virginia, États-Unis, 26505
- Recrutement
- Frontier Clinical Research
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Wisconsin
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Kenosha, Wisconsin, États-Unis, 53144
- Recrutement
- Clinical Investigation Specialists, Inc.
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
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%;
- Participant voluntarily agrees to participate in the study by giving written informed consent;
- Participant is able to read, understand, and complete the study questionnaires and diary;
- Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;
- 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;
- 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:
- 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);
- 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);
- 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;
- 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;
- Has any major surgery scheduled for the duration of the trial;
- 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;
- At Visit 1, has an open/ongoing adverse event from the base study EoS visit;
- Experienced a serious adverse event in the base study;
- Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Elismetrep 10 mg
|
Administré par voie orale
Administered orally
Autres noms:
|
|
Expérimental: Elismetrep 20 mg
|
Administered orally
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Proportion of participants with at least one treatment-emergent adverse event (TEAE)
Délai: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
|
Proportion of participants with at least one treatment-emergent serious adverse event (SAE)
Délai: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
|
Proportion of participants with TEAEs leading to study drug discontinuation
Délai: Through study completion, an average of 1 year
|
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
Délai: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
3 août 2026
Achèvement primaire (Estimé)
1 juin 2028
Achèvement de l'étude (Estimé)
1 juin 2028
Dates d'inscription aux études
Première soumission
15 juin 2026
Première soumission répondant aux critères de contrôle qualité
23 juin 2026
Première publication (Réel)
29 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- K-304 P005
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .