Long-term safety study of elismetrep for acute migraine attacks
Tests elismetrep, taken as needed, for safety in adults with migraine.
Plain-language title generated from the registry record
Registry title: A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
Key facts
- Where
- Albuquerque, Allentown, Amherst, Ann Arbor, Atlanta, Austin, Bardstown, Birmingham, Boston, Bountiful, Brooklyn, Centennial, Chalmette, Chandler, Charlotte, Chattanooga, Chicago, City of Saint Peters, Colorado Springs, Colton, Columbus, Commack, Culver City, Cypress, Dallas, Draper, Edmond, Encino, Flossmoor, Fort Collins, Greensboro, Gulfport, Hazelwood, Houston, Irvine, Kansas City, Kenosha, Lampasas, Las Vegas, Lexington, Little Rock, Los Angeles, Manlius, Marietta, Milford, Minneapolis, Mission Viejo, Mobile, Morgantown, Naperville, Nashville, New Orleans, New York, Newport News, Norfolk, North Charleston, North Las Vegas, Oceanside, Ogden, Oklahoma City, Overland Park, Philadelphia, Pikesville, Pittsburgh, Plano, Pomona, Portland, Raleigh, Reno, Ridgeland, Riverside, Riverton, Rochester, Salt Lake City, San Diego, Scottdale, Seattle, Shelby, Sherman Oaks, Smithfield, Spring Valley, Springfield, St Louis, Stockbridge, Tulsa, Walnut Creek, Waltham, Waterbury, Waxahachie, West Chester, West Covina, West Des Moines, West Hills, Wichita, Williamsville, and Yukon, United StatesSee the 112 sites
- Phase
- Phase 3
Where in United States
- Albuquerque Clinical TrialsAlbuquerque, United StatesTaking people
- Lehigh Center for Clinical ResearchAllentown, United StatesTaking people
- Dent Neuro Institute, BuffaloAmherst, United StatesTaking people
- Michigan Headache Pain & Neurological InstituteAnn Arbor, United StatesTaking people
- DelRicht ResearchAtlanta, United StatesTaking people
- FutureSearch Trials of NeurologyAustin, United StatesTaking people
- Tekton ResearchAustin, United StatesTaking people
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)Bardstown, United StatesTaking people
- Central Research Associates, LLC (CRA) dba Flourish ResearchBirmingham, United StatesTaking people
- Boston Clinical Trials - AlcanzaBoston, United StatesTaking people
- Pantheon Clinical ResearchBountiful, United StatesTaking people
- SPRI Clinical Trials, LLCBrooklyn, United StatesTaking people
- IMMUNOe Research CentersCentennial, United StatesTaking people
- Crescent City Headache & Neurology CenterChalmette, United StatesTaking people
- TrialSphereChandler, United StatesTaking people
- OnSite Clinical SolutionsCharlotte, United StatesTaking people
- WR-ClinSearch, LLCChattanooga, United StatesTaking people
- Cedar Crosse Research CenterChicago, United StatesTaking people
- Chicago Headache Center & Research InstituteChicago, United StatesTaking people
- StudyMetrix ResearchCity of Saint Peters, United StatesTaking people
- MCB Clinical Research CentersColorado Springs, United StatesTaking people
- Axiom Research, LLCColton, United StatesTaking people
- Hometown ResearchColumbus, United StatesTaking people
- True North NeurologyCommack, United StatesTaking people
- ProScience Research GroupCulver City, United StatesTaking people
- APD Clinical ResearchCypress, United StatesTaking people
- Horizon Clinical Research and Gill NeuroscienceCypress, United StatesTaking people
- FutureSearch Trials of Dallas, LPDallas, United StatesTaking people
- J. Lewis Research, Inc. / Foothill Family Clinic DraperDraper, United StatesTaking people
- OK Clinical Research, LLCEdmond, United StatesTaking people
- Leading Edge Research LA, LLCEncino, United StatesTaking people
- Healthcare Research Network II, LLCFlossmoor, United StatesTaking people
- Advanced Neurosciences ResearchFort Collins, United StatesTaking people
- Guilford Neurologic Research Partners, LLCGreensboro, United StatesTaking people
- Headache Wellness CenterGreensboro, United StatesTaking people
- DelRicht ResearchGulfport, United StatesTaking people
- Healthcare Research NetworkHazelwood, United StatesTaking people
- DM Clinical ResearchHouston, United StatesTaking people
- Victorium Clinical ResearchHouston, United StatesTaking people
- Axiom Research, Orange CountyIrvine, United StatesTaking people
- AMR Clinical - Kansas CityKansas City, United StatesTaking people
- Clinical Investigation Specialists, Inc.Kenosha, United StatesTaking people
- GMG Clinical Research, LLC dba Radiance Clinical ResearchLampasas, United StatesTaking people
- AMR Clinical - Las VegasLas Vegas, United StatesTaking people
- Excel Clinical ResearchLas Vegas, United StatesTaking people
- IMA Clinical Research - Las VegasLas Vegas, United StatesTaking people
- Redbird ResearchLas Vegas, United StatesTaking people
- Wake Research Las Vegas RainbowLas Vegas, United StatesTaking people
- AMR Clinical - LexingtonLexington, United StatesTaking people
- CTI Clinical Research CenterLexington, United StatesTaking people
- Arkansas Clinical ResearchLittle Rock, United StatesTaking people
- Clinical Research InstituteLos Angeles, United StatesTaking people
- Downtown L.A. Research Center, Inc.Los Angeles, United StatesTaking people
- Central New York Clinical ResearchManlius, United StatesTaking people
- Drug Studies AmericaMarietta, United StatesTaking people
- Hometown ResearchMilford, United StatesTaking people
- Clinical Research InstituteMinneapolis, United StatesTaking people
- M3 Wake Research - Mission Mental Health (WR-MMH)Mission Viejo, United StatesTaking people
- AMR MobileMobile, United StatesTaking people
- Frontier Clinical ResearchMorgantown, United StatesTaking people
- Chicago Headache Center & Research InstituteNaperville, United StatesTaking people
- Access Clinical Trials, IncNashville, United StatesTaking people
- Clinical Research Associates, Inc.Nashville, United StatesTaking people
- Delricht ResearchNew Orleans, United StatesTaking people
- Fieve Clinical Research, IncNew York, United StatesTaking people
- Health Research of Hampton Roads, Inc. (HRHR)Newport News, United StatesTaking people
- AMR Clinical - NorfolkNorfolk, United StatesTaking people
- Coastal Carolina Research CenterNorth Charleston, United StatesTaking people
- Las Vegas Clinical TrialsNorth Las Vegas, United StatesTaking people
- Excell ResearchOceanside, United StatesTaking people
- Advanced Research InstituteOgden, United StatesTaking people
- Hightower ClinicalOklahoma City, United StatesTaking people
- Clinical Associates Midwest, LLCOverland Park, United StatesTaking people
- Collective Medical ResearchOverland Park, United StatesTaking people
- Clinical Research PhiladelphiaPhiladelphia, United StatesTaking people
- Headlands Research PharmasitePikesville, United StatesTaking people
- Preferred Primary Care Physicians, Inc.Pittsburgh, United StatesTaking people
- Aim Trials, LLCPlano, United StatesTaking people
- Empire Clinical ResearchPomona, United StatesTaking people
- The Neurology GroupPomona, United StatesTaking people
- Advanced Research Institute - PortlandPortland, United StatesTaking people
- Summit Research NetworkPortland, United StatesTaking people
- Eximia Research - NC, LLCRaleigh, United StatesTaking people
- Advanced Research Institute - RenoReno, United StatesTaking people
- Proven EndpointsRidgeland, United StatesTaking people
- Artemis Institute for Clinical ResearchRiverside, United StatesTaking people
- Granger Medical ClinicRiverton, United StatesTaking people
- Rochester Clinical ResearchRochester, United StatesTaking people
- J. Lewis Research, Inc. / Foothill Family ClinicSalt Lake City, United StatesTaking people
- Acclaim Clinical ResearchSan Diego, United StatesTaking people
- Frontier Clinical Research, LLCScottdale, United StatesTaking people
- Seattle Clinical Research CenterSeattle, United StatesTaking people
- Carolina Research Center, IncShelby, United StatesTaking people
- CenExel Sherman Oaks CA (California Neuroscience Research)Sherman Oaks, United StatesTaking people
- Frontier Clinical Research, LLCSmithfield, United StatesTaking people
- Encompass Clinical ResearchSpring Valley, United StatesTaking people
- Clinvest Headlands LLCSpringfield, United StatesTaking people
- Sundance Clinical ResearchSt Louis, United StatesTaking people
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-StockbridgeStockbridge, United StatesTaking people
- DelRicht ResearchTulsa, United StatesTaking people
- Diablo Clinical ResearchWalnut Creek, United StatesTaking people
- Sunwise Clinical ResearchWalnut Creek, United StatesTaking people
- MedVadis Research Corporation, LLCWaltham, United StatesTaking people
- Chase Medical Research, LLCWaterbury, United StatesTaking people
- Clinpoint TrialsWaxahachie, United StatesTaking people
- CincyScienceWest Chester, United StatesTaking people
- Kinetic Clinical ResearchWest Covina, United StatesTaking people
- Integrated Clinical Trials SolutionWest Des Moines, United StatesTaking people
- Focus Clinical ResearchWest Hills, United StatesTaking people
- Heartland Research Associates, LLC - An AMR CompanyWichita, United StatesTaking people
- Upstate Clinical Research AssociatesWilliamsville, United StatesTaking people
- Tekton Research, Inc.Yukon, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- TriGemX Bio, Inc.
- Trial code
- NCT07674654
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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:; 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: 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 previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures; 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); 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); 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; 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.