A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Kallyope Inc.
Study ID
NCT06848075
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

First listed
Feb 26, 2025
Start date
Mar 11, 2025
Status verified
Aug 2026
Primary completion
Aug 4, 2025
Completion
Aug 4, 2025

Study Design

Enrollment
431 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elismetrep (K-304) Dose Level 1
    Participants received a single dose of elismetrep 2 mg
  • Experimental: Elismetrep (K-304) Dose Level 2
    Participants received a single dose of elismetrep 5 mg
  • Experimental: Elismetrep (K-304) Dose Level 3
    Participants received a single dose of elismetrep 10 mg
  • Experimental: Elismetrep (K-304) Dose Level 4
    Participants received a single dose of elismetrep 20 mg
  • Placebo Comparator: Placebo
    Participants received a single dose of elismetrep-matched placebo

Primary Outcome Measure

Pain Freedom [ Time Frame: 2 hours post-dose ]

Locations (66)

FacilityCityStateZIPSite coordinators
Central Research Associates, LLC (CRA) dba Flourish ResearchBirminghamAlabama35205-
AMR MobileMobileAlabama36608-
Wake Research/ Tucson Neuroscience ResearchTucsonArizona85710-
Hope Clinical ResearchCanoga ParkCalifornia91303-
WR-PRI, LLC (Encino)EncinoCalifornia91316-
Marvel Clinical ResearchHuntington BeachCalifornia92647-
Eximia Research - CALa MesaCalifornia91942-
Synergy San DiegoLemon GroveCalifornia91945-
WR-PRI, LLC (Newport Beach)Newport BeachCalifornia92660-
Excell Research, Inc.OceansideCalifornia92056-
Empire Clinical ResearchPomonaCalifornia91767-
Artemis Institute for Clinical Research - RiversideRiversideCalifornia92503-
Acclaim Clinical ResearchSan DiegoCalifornia89109-
Artemis Institute for Clinical Research - San DiegoSan DiegoCalifornia92103-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Focus Clinical ResearchWest HillsCalifornia91307-
CT Clinical ResearchCromwellConnecticut06416-
DelRicht ResearchAtlantaGeorgia30329-
Clinical Research Atlanta - StockbridgeStockbridgeGeorgia30281-
Northwest Clinical TrialsBoiseIdaho83704-
Cedar Crosse Research CenterChicagoIllinois60607-
Healthcare Research Network II, LLCFlossmoorIllinois60422-
Collective Medical ResearchOverland ParkKansas66202-
Alliance for Multispecialty ResearchWichitaKansas67207-
L-MARC Research CenterLouisvilleKentucky40213-
Crescent City Headache & Neurology CenterChalmetteLouisiana70043-
DelRicht ResearchNew OrleansLouisiana70115-
Michigan Head Pain and Neurological InstituteAnn ArborMichigan48104-
Clinical Research InstituteMinneapolisMinnesota55402-
DelRicht ResearchGulfportMississippi39503-
Healthcare Research NetworkHazelwoodMissouri63042-
Excel Clinical ResearchLas VegasNevada89109-
Las Vegas Clinical TrialsNorth Las VegasNevada89119-
Albuquerque Clinical Trials, Inc.AlbuquerqueNew Mexico87102-
Dent Neurosciences Research CenterAmherstNew York14226-
CNY Clinical ResearchManliusNew York13104-
Rochester Clinical ResearchRochesterNew York14609-
Upstate Clinical Research Associates LLCWilliamsvilleNew York14221-
Headache Wellness CenterGreensboroNorth Carolina27405-
Peters Medical ResearchHigh PointNorth Carolina27260-
CTI Clinical Research CenterCincinnatiOhio45212-
OK Clinical Research, LLCEdmondOklahoma73034-
Hightower ClinicalOklahoma CityOklahoma73102-
DelRicht ResearchTulsaOklahoma74133-
Tekton ResearchYukonOklahoma73099-
Summit Research NetworkPortlandOregon97210-
Lehigh Center for Clinical ResearchAllentownPennsylvania18103-
Clinical Research Philadelphia, LLCPhiladelphiaPennsylvania19114-
Frontier Clinical Research, LLCScottdalePennsylvania15683-
Frontier Clinical Research, LLCSmithfieldPennsylvania15478-
Atlas-ClinicalWest ChesterPennsylvania19380-
Clinical Trials of South CarolinaCharlestonSouth Carolina29406-
Coastal Carolina Research CenterNorth CharlestonSouth Carolina29405-
WR-ClinSearchChattanoogaTennessee37421-
AMR Knoxville (Formerly NOCCR)KnoxvilleTennessee37909-
Clinical Research Associates, Inc.NashvilleTennessee37203-
Donald J Garcia Jr, MD, PAAustinTexas78737-
Tekton ResearchAustinTexas78745-
FutureSearch Trials of Dallas, LPDallasTexas75251-
Victorium Clinical Research LTD COHoustonTexas77024-
APD Clinical ResearchSplendoraTexas77372-
ClinPoint TrialsWaxahachieTexas75165-
Advanced Research InstituteOgdenUtah84405-
Health Research of Hampton Roads, Inc.Newport NewsVirginia23606-
Frontier Clinical Research, LLCMorgantownWest Virginia26505-
Clinical Investigation SpecialistKenoshaWisconsin53144-

Find similar trials in Birmingham, AL

Nationwide
Migraine trialsNeurology trials
By condition
Migraine
By specialty
Neurology
By research site
Central Research Associates, LLC (CRA) dba Flourish Research· Birmingham, ALAMR Mobile· Mobile, ALWake Research/ Tucson Neuroscience Research· Tucson, AZHope Clinical Research· Canoga Park, CAWR-PRI, LLC (Encino)· Encino, CAMarvel Clinical Research· Huntington Beach, CA

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