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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Kallyope Inc.
Study ID
NCT07674654
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Acute Migraine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elismetrep — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elismetrep 10 mg
  • Experimental: Elismetrep 20 mg

Primary Outcome Measure

Proportion of participants with at least one treatment-emergent adverse event (TEAE) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (119)

FacilityCityStateZIPSite coordinators
Central Research Associates, LLC (CRA) dba Flourish ResearchBirminghamAlabama35205-
AMR MobileMobileAlabama36608-
TrialSphereChandlerArizona85286-
Arkansas Clinical ResearchLittle RockArkansas72205-
Axiom Research, LLCColtonCalifornia92324-
ProScience Research GroupCulver CityCalifornia90230-
Leading Edge Research LA, LLCEncinoCalifornia91316-
Axiom Research, Orange CountyIrvineCalifornia92604-
Clinical Research InstituteLos AngelesCalifornia90048-
Downtown L.A. Research Center, Inc.Los AngelesCalifornia90017-
M3 Wake Research - Mission Mental Health (WR-MMH)Mission ViejoCalifornia92691-
Excell ResearchOceansideCalifornia92056-
Empire Clinical ResearchPomonaCalifornia91767-
The Neurology GroupPomonaCalifornia91767-
Artemis Institute for Clinical ResearchRiversideCalifornia92503-
Acclaim Clinical ResearchSan DiegoCalifornia92120-
CenExel Sherman Oaks CA (California Neuroscience Research)Sherman OaksCalifornia91403-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
Diablo Clinical ResearchWalnut CreekCalifornia94598-
Sunwise Clinical ResearchWalnut CreekCalifornia94596-
Kinetic Clinical ResearchWest CovinaCalifornia91790-
Focus Clinical ResearchWest HillsCalifornia91307-
IMMUNOe Research CentersCentennialColorado80112-
MCB Clinical Research CentersColorado SpringsColorado80910-
Advanced Neurosciences ResearchFort CollinsColorado80528-
Chase Medical Research, LLCWaterburyConnecticut06708-
DelRicht ResearchAtlantaGeorgia30329-
Drug Studies AmericaMariettaGeorgia30060-
Sleep Care Research Institute d/b/a Clinical Research Atlanta-StockbridgeStockbridgeGeorgia30281-
Cedar Crosse Research CenterChicagoIllinois60607-
Chicago Headache Center & Research InstituteChicagoIllinois60657-
Healthcare Research Network II, LLCFlossmoorIllinois60447-
Chicago Headache Center & Research InstituteNapervilleIllinois60563-
Integrated Clinical Trials SolutionWest Des MoinesIowa50265-
Clinical Associates Midwest, LLCOverland ParkKansas66214-
Collective Medical ResearchOverland ParkKansas66212-
Heartland Research Associates, LLC - An AMR CompanyWichitaKansas67207-
Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)BardstownKentucky40004-
AMR Clinical - LexingtonLexingtonKentucky40509-
CTI Clinical Research CenterLexingtonKentucky45212-
Monroe Biomedical Research (former L-MARC Research Center)LouisvilleKentucky40213-
Crescent City Headache & Neurology CenterChalmetteLouisiana70043-
DelRicht ResearchNew OrleansLouisiana70115-
Headlands Research - PharmaSitePikesvilleMaryland21208-
Boston Clinical Trials - AlcanzaBostonMassachusetts02131-
MedVadis Research Corporation, LLCWalthamMassachusetts02451-
Michigan Headache Pain & Neurological InstituteAnn ArborMichigan48104-
Minneapolis Clinic of NeurologyBurnsvilleMinnesota55337-
Clinical Research InstituteMinneapolisMinnesota55402-
DelRicht ResearchGulfportMississippi39503-
Proven EndpointsRidgelandMississippi39157-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Healthcare Research NetworkHazelwoodMissouri63042-
AMR Clinical - Kansas CityKansas CityMissouri64114-
Clinvest Headlands LLCSpringfieldMissouri65807-
Sundance Clinical ResearchSt LouisMissouri63141-
AMR Clinical - Las VegasLas VegasNevada89119-
Excel Clinical ResearchLas VegasNevada89109-
IMA Clinical Research - Las VegasLas VegasNevada89102-
Redbird ResearchLas VegasNevada89119-
Wake Research Las Vegas RainbowLas VegasNevada89118-
Las Vegas Clinical TrialsNorth Las VegasNevada89030-
Advanced Research Institute-RenoRenoNevada89511-
Albuquerque Clinical TrialsAlbuquerqueNew Mexico87102-
Dent Neuro Institute, BuffaloAmherstNew York14226-
SPRI Clinical Trials, LLCBrooklynNew York11235-
True North NeurologyCommackNew York11725-
Central New York Clinical ResearchManliusNew York13104-
Fieve Clinical Research, IncNew YorkNew York10017-
Rochester Clinical ResearchRochesterNew York14609-
Upstate Clinical Research AssociatesWilliamsvilleNew York14221-
OnSite Clinical SolutionsCharlotteNorth Carolina28277-
Guilford Neurologic Research Partners, LLCGreensboroNorth Carolina27405-
Headache Wellness CenterGreensboroNorth Carolina27405-
Eximia Research - NC, LLCRaleighNorth Carolina27607-
Carolina Research Center, IncShelbyNorth Carolina28150-
Hometown ResearchColumbusOhio43228-
Hometown ResearchHuber HeightsOhio45424-
Hometown ResearchMilfordOhio45150-
CincyScienceWest ChesterOhio45069-
OK Clinical Research, LLCEdmondOklahoma73034-
Hightower ClinicalOklahoma CityOklahoma73102-
DelRicht ResearchTulsaOklahoma74133-
Tekton Research, Inc.YukonOklahoma73099-
Advanced Research Institute-PortlandPortlandOregon97223-
Summit Research NetworkPortlandOregon97210-
Lehigh Center for Clinical ResearchAllentownPennsylvania18103-
Clinical Research PhiladelphiaPhiladelphiaPennsylvania19114-
Preferred Primary Care Physicians, Inc.PittsburghPennsylvania15236-
Frontier Clinical Research, LLCScottdalePennsylvania15683-
Frontier Clinical Research, LLCSmithfieldPennsylvania15478-
Coastal Carolina Research CenterNorth CharlestonSouth Carolina29405-
WR-ClinSearch, LLCChattanoogaTennessee37421-
Access Clinical Trials IncNashvilleTennessee37203-
Clinical Research Associates, Inc.NashvilleTennessee37203-
FutureSearch Trials of NeurologyAustinTexas78731-
Tekton ResearchAustinTexas78745-
APD Clinical ResearchCypressTexas77372-
Horizon Clinical Research and Gill NeuroscienceCypressTexas77429-
FutureSearch Trials of Dallas, LPDallasTexas75251-
Relaro Medical Trials, LLCDallasTexas75243-
Helios CR, Inc. - Fort WorthFort WorthTexas76104-
DM Clinical ResearchHoustonTexas77081-
Victorium Clinical ResearchHoustonTexas77024-
Helios CR, Inc. - KellerKellerTexas76248-
GMG Clinical Research, LLC dba Radiance Clinical ResearchLampasasTexas76550-
Aim Trials, LLCPlanoTexas75093-
ClinPoint TrialsWaxahachieTexas75165-
Pantheon Clinical ResearchBountifulUtah84010-
J. Lewis Research, Inc. / Foothill Family Clinic DraperDraperUtah84020-
Advanced Research InstituteOgdenUtah84405-
Granger Medical ClinicRivertonUtah84096-
J. Lewis Research, Inc. / Foothill Family ClinicSalt Lake CityUtah84109-
J. Lewis Research, Inc. / Foothill Family ClinicSalt Lake CityUtah84121-
Health Research of Hampton Roads, Inc. (HRHR)Newport NewsVirginia23606-
AMR Clinical - NorfolkNorfolkVirginia23502-
Seattle Clinical Research CenterSeattleWashington98104-
Frontier Clinical ResearchMorgantownWest Virginia26505-
Clinical Investigation Specialists, Inc.KenoshaWisconsin53144-

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