A Study to Assess the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Kallyope Inc.
Study ID
NCT07816367
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 — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine.

Key Dates

First listed
Sep 11, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elismetrep 10 mg
    Participants received a single dose of elismetrep 10 mg
  • Experimental: Elismetrep 20 mg
    Participants received a single dose of elismetrep 20 mg
  • Placebo Comparator: Placebo
    Participants received a single dose of placebo

Primary Outcome Measure

Pain freedom at 2 hours post-dose [ Time Frame: Two hours post-dose ]

Central Contacts

  • Michael Crutchlow Kallyope Clinical Director and Medical Monitor, MD
    267-242-5109
    [email protected]

Locations (72)

FacilityCityStateZIPSite coordinators
Sun City Clinical ResearchGlendaleArizona85304
Jan Watson
[email protected]
623-253-9777
IMA Clinical Research - PhoenixPhoenixArizona85012
Payam Sadr
[email protected]
602-562-7000
Velocity Clinical Research, PhoenixPhoenixArizona85006
C Stephen Plimpton
[email protected]
602-368-1928
Preferred Research Partners, Inc.Little RockArkansas72211
Paul Wylie
[email protected]
501-553-9987
Alliance Research Institute, Canoga ParkCanoga ParkCalifornia91304
Arash Matian
[email protected]
818-835-9085
Velocity Clinical Research, Chula VistaChula VistaCalifornia91911
J Scott Overcash
[email protected]
619-955-5246
Ark Clinical Research, Fountain ValleyFountain ValleyCalifornia92708
Mark Leibowitz
[email protected]
310-710-2985
Neurology Center of North Orange CountyFullertonCalifornia92835
Anthony Ciabarra
[email protected]
714-879-7200
Axiom Research, Los Angeles LLCGlendaleCalifornia91206
Morgan Welebir
[email protected]
909-824-2335
Accellacare - Long BeachLong BeachCalifornia90807
Elizabeth Zarate-Rowell
[email protected]
562-492-9966
Long Beach Clinical Trials Services, IncLong BeachCalifornia90806
Suzanne Fussell
[email protected]
562-997-3869
Alliance Research Institute, LynwoodLynwoodCalifornia90262
Nijole Glaze
[email protected]
818-835-9085
Northridge Clinical TrialsNorthridgeCalifornia91325
Sabreen Faqihi
[email protected]
818-350-7483
Pasadena Clinical TrialsPasadenaCalifornia91101
Tzu-Jen Tzao
[email protected]
626-822-6554
Paradigm Clinical Research Centers, LLCReddingCalifornia96001
Sheila Finch
[email protected]
530-247-7049
Infinity Clinical TrialsSan DiegoCalifornia92108
Jay Pandit
[email protected]
619-704-0808
Paradigm Clinical Research Centers, LLCSan DiegoCalifornia92108
Gary Boone
[email protected]
858-274-4226
Optimus Medical GroupSan FranciscoCalifornia94102
Shawn Hassler
[email protected]
415-518-1292
Paragon Rx ClinicalSanta AnaCalifornia92703
Kelvin Mai
[email protected]
714-617-5689
Velocity Clinical Research, Van NuysVan NuysCalifornia91606
Mark Turner
[email protected]
818-487-3741
Paradigm Clinical Research Centers, LLC; AuroraAuroraColorado80012
Nathaniel Moore
[email protected]
303-219-1830
Centennial Clinical TrialsDenverColorado80246
Alan Shackelford
[email protected]
650-995-4233
Ki Health Partners, LLCStamfordConnecticut06905-1206
Peter Mcallister
[email protected]
203-914-1900
Velocity Clinical Research, Hallandale BeachHallandaleFlorida33009
Beth Safirstein
[email protected]
954-455-5757
Clinical Research of Central FloridaLakelandFlorida33805
Cecilia Arango
[email protected]
1-863-853-5400
AppleMedical Research Group, LLCMiamiFlorida33155
Agustin Latorre
[email protected]
305-667-8434
Sensible Healthcare, LLCOcoeeFlorida34761
Kelly Taylor
[email protected]
407-654-2724
Clinical Associates of Orlando, LLCOrlandoFlorida32819
Anna Lizama Clark
[email protected]
407-269-0322
Cenexel Tampa FLTampaFlorida33613
Deborah White
[email protected]
813-264-2155
Premiere Research Institute at Palm Beach NeurologyWest Palm BeachFlorida33407
Paul Winner
[email protected]
561-845-0500
Clinical Integrative Research Center of AtlantaAtlantaGeorgia30328
Frank Berenson
[email protected]
678-705-7341
Evergreen Clinical TrialsNorcrossGeorgia30092
Dmitriy Pelishev
[email protected]
678-884-0550
Velocity Clinical Research, SavannahSavannahGeorgia31406
Paul Bradley
[email protected]
912-443-4253
Paradigm Clinical Research Centers, LLCBoiseIdaho83709
James Herrold
[email protected]
208-801-7440
Clinical Investigation Specialists, Inc.GurneeIllinois60031
Luis Gonzalez-Orozco
[email protected]
847-599-2492
Evanston Premier Healthcare Research, LLCSkokieIllinois60077
Jeffrey Geohas
[email protected]
847-869-1191
DM Clinical Research, IndianapolisIndianapolisIndiana46254
Brandon Essink
[email protected]
463-271-3050
Indiana Medical Research InstituteMerrillvilleIndiana46410
Arshad Malik
[email protected]
219-207-5053
Accellacare - McFarland |AmesIowa50010
Jennifer Killion
[email protected]
515-956-4159
Velocity Clinical Research, Sioux CitySioux CityIowa51106
David Ensz
[email protected]
712-639-6300
NECCR PrimaCare Research, LLCFall RiverMassachusetts02721
Ehab Sorial
[email protected]
508-672-7450
Neurology Center of New England P.C.FoxboroughMassachusetts02035
Salvatore Napoli
[email protected]
781-551-5812
Montana Medical Research, IncMissoulaMontana59808
Clancy Cone
[email protected]
406-519-2132
Velocity Clinical Research, NorfolkNorfolkNebraska68701
Charles Harper
[email protected]
402-371-0797
Quality Clinical Research, Inc.OmahaNebraska68114
Ariana Bauer
[email protected]
402-934-0044
Oasis Clinical ResearchLas VegasNevada89121
Stephen Tam
[email protected]
702-832-1369
Bio Behavioral HealthToms RiverNew Jersey08755
Ashok Patel
[email protected]
732-244-2299
Accellacare - Cary (Cary Medical Group)CaryNorth Carolina27518
Sylvia Shoffner
[email protected]
919-342-3447
West Clinical ResearchMorehead CityNorth Carolina28557
Patrick Morgante
[email protected]
252-515-0050
Accellacare - Raleigh (Raleigh Medical Group, P.A.)RaleighNorth Carolina27609
John Rubino
[email protected]
919-783-4895
Accellacare - WilmingtonWilmingtonNorth Carolina28401
Kevin Cannon
[email protected]
910-799-5500
Accellacare - Winston-SalemWinston-SalemNorth Carolina27103
Mitchell Isaac
[email protected]
336-768-8062
Lillestol ResearchFargoNorth Dakota58104
Michael Lillestol
[email protected]
701-232-7705
Velocity Clinical Research, ClevelandBeachwoodOhio44122
Margaret Rhee
[email protected]
216-682-0320
Velocity Clinical Research, Cincinnati, Blue AshBlue AshOhio45242
Audrius Ruksenas
[email protected]
513-769-2767
Headache Center of HopeCincinnatiOhio45236
Hope O'Brien
[email protected]
513-898-9400
Centricity Research; Columbus, OhioColumbusOhio43213
Sridhar Guduri
[email protected]
614-501-6164
Velocity Clinical Research, ProvidenceProvidenceRhode Island02818
David Fried
[email protected]
401-739-9350
Velocity Clinical Research, AndersonAndersonSouth Carolina29621
Daniel Williams
[email protected]
864-965-0190
Velocity Clinical Research, GaffneyGaffneySouth Carolina29340
David Erb
[email protected]
864-488-1283
Central Texas Clinical ResearchAustinTexas78705
Cynthia Brinson
[email protected]
512-480-9660
Gadolin Research, LLCBeaumontTexas77702
Kandasami Senthilkumar
[email protected]
409-331-6040
Velocity Clinical Research, DallasDallasTexas75230
Jennifer Bashour
[email protected]
682-348-1169
Epic Medical Research - DeSotoDeSotoTexas75115
Pritesh Patel
[email protected]
972-777-6954
Newco 3A Researh LLC, DBA 3A ResearchEl PasoTexas79902
Aldo Maspons
[email protected]
915 598-8888
Red Star ResearchLake JacksonTexas77566
Harvey Resnick
[email protected]
979-529-9440
Clinical Trials of Texas, LLC, A Flourish Research SiteSan AntonioTexas78229
Parke Hedges
[email protected]
210-949-0122
San Antonio Clinical TrialsSan AntonioTexas78240
Dempsey Gordon Jr.
[email protected]
945-218-5593
DM Clinical Research, Sugar LandSugar LandTexas77479
Irfan Lalani
[email protected]
346-550-9559
DM Clinical Research, TomballTomballTexas77375
Muhammad Irfan
[email protected]
281-517-0550
Highland Clinical ResearchSalt Lake CityUtah84124
Derek Muse
[email protected]
801-559-3855
Wasatch Clinical Research, LLCSalt Lake CityUtah84107
David Larsen
[email protected]
801-288-0607

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By specialty
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By research site
Sun City Clinical Research· Glendale, AZIMA Clinical Research - Phoenix· Phoenix, AZVelocity Clinical Research, Phoenix· Phoenix, AZPreferred Research Partners, Inc.· Little Rock, ARAlliance Research Institute, Canoga Park· Canoga Park, CAVelocity Clinical Research, Chula Vista· Chula Vista, CA

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