A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT05127486
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Galcanezumab — DRUG
    Administered SC.
  • Rimegepant — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered SC.

Study Details

The purpose of this study is to assess whether galcanezumab is superior to rimegepant in the prevention of migraine in participants with episodic migraine. The study duration will be approximately 6 months.

Key Dates

Start date
Dec 6, 2021
Status verified
Jun 2024
Primary completion
May 23, 2023
Completion
May 23, 2023

Study Design

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

Arms

  • Experimental: Galcanezumab
    Participants received a loading dose of 2 injections of 120 milligrams (mg) galcanezumab subcutaneously (SC) in the first month followed by 120 mg monthly for remaining 2 months. 1 placebo oral disintegrating tablet (ODT) every other day for 3 months was given to preserve blinding.
  • Active Comparator: Rimegepant
    Participants received 75 mg Rimegepant oral disintegrating tablet (ODT) every other day for 3 months. 2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.

Primary Outcome Measure

Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period. [ Time Frame: Baseline, Month 1 through Month 3 ]

Locations (77)

FacilityCityStateZIPSite coordinators
Gilbert NeurologyGilbertArizona85297-
Foothills Research Center / CCT ResearchPhoenixArizona85044-
Alliance for Multispecialty Research, LLC TempeTempeArizona85281-
Velocity Clinical Research, BanningBanningCalifornia99202-
Velocity Clinical Research, Chula VistaChula VistaCalifornia91911-
Wr- Pri, LlcEncinoCalifornia91316-
Velocity Clinical Research, San DiegoLa MesaCalifornia91942-
California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility)Los AngelesCalifornia90067-
Pharmacology Research InstituteNewport BeachCalifornia92660-
Velocity Clinical Research, North HollywoodNorth HollywoodCalifornia91606-
Anderson Clinical ResearchRedlandsCalifornia92374-
Center for Clinical Trials of SacramentoSacramentoCalifornia95823-
Velocity Clinical Research, Huntington ParkSanta AnaCalifornia92704-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
CMR of Greater New Haven, LLCHamdenConnecticut06517-
Innovative Research of West FloridaClearwaterFlorida33756-
AMR MiamiCoral GablesFlorida33134-
Accel Research Sites- Clinical Research UnitDeLandFlorida32720-
Velocity Clinical Research, Hallandale BeachHallandaleFlorida33009-
Accel Research Sites-LKD CRULakelandFlorida33803-
Visionary Investigators NetworkMiamiFlorida33176-
Visionary Investigators NetworkMiamiFlorida33180-
Sensible Healthcare, LLCOcoeeFlorida34761-
University of South FloridaTampaFlorida33612-
Palm Beach Research CenterWest Palm BeachFlorida33409-
DelRicht ResearchAtlantaGeorgia30329-
Better Health Clinical ResearchNewnanGeorgia30265-
Meridian Clinical ResearchSavannahGeorgia31406-
Chicago Headache CenterChicagoIllinois60657-
American Health Network of Indiana, LLC - AvonAvonIndiana46123-
Deaconess ClinicEvansvilleIndiana47713-
Alliance for Multispecialty Research, LLC El DoradoEl DoradoKansas67042-
Alliance for Multispecialty Research, LLC LexingtonLexingtonKentucky40509-
L-MARC Research CenterLouisvilleKentucky40213-
DelRicht ResearchCovingtonLouisiana70433-
DelRicht ResearchNew OrleansLouisiana70124-
DelRicht ResearchPrairievilleLouisiana70769-
Boston Clinical TrialsBostonMassachusetts02131-
Michigan Headache & Neurological InstituteAnn ArborMichigan48104-
Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroyMichigan48098-
MedPharmics, LLCGulfportMississippi39503-
Healthcare Research Network - St. LouisHazelwoodMissouri63042-
Alliance for Multispecialty Research, LLCLas VegasNevada89119-
Albuquerque Clinical Trials, Inc.AlbuquerqueNew Mexico87102-
Dent Neurosciences Research Center (Research Facility)AmherstNew York14226-
Rochester Clinical Research, Inc.RochesterNew York14609-
North Carolina Clinical ResearchRaleighNorth Carolina27607-
NeuroScience Research Center, LLCCantonOhio44718-
Dayton Center for Neurological DisordersCentervilleOhio45459-
Neurology Diagnostics, Inc.DaytonOhio45459-
Tekton ResearchEdmondOklahoma73013-
Lynn Institute of NormanNormanOklahoma73072-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
DelRicht ResearchTulsaOklahoma74133-
Tekton ResearchYukonOklahoma73099-
Velocity Clinical Research, Grants Pass (Research Facility)Grants PassOregon97527-
Velocity Clinical Research - MedfordMedfordOregon97504-
Velocity Clinical Research, ProvidenceEast GreenwichRhode Island02818-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
Premier Neurology Research, P.C.GreerSouth Carolina29650-
Coastal Carolina Research CenterNorth CharlestonSouth Carolina29405-
Alliance for Multispecialty Research, LLCKnoxvilleTennessee37920-
Clinical Research AssociatesNashvilleTennessee37203-
ACRC TrialsAustinTexas78735-
FutureSearch Trials of NeurologyAustinTexas78731-
Tekton Research (Research Facility)AustinTexas78705-
ACRC TrialsCarrolltonTexas75010-
Velocity Clinical Research, AustinCedar ParkTexas78613-
Ventavia Research GroupFort WorthTexas76104-
Accurate Clinical Management - HoustonHoustonTexas77065-
Dynamed Clinical Research, LP d/b/a DM Clinical ResearchHumbleTexas77064-
Ventavia Research Group - KellerKellerTexas76248-
ACRC TrialsPlanoTexas75024-
Alpine Research OrganizationClintonUtah84015-
Advanced Clinical ResearchWest JordanUtah84088-
Alliance for Multispecialty Research, LLC - AMR NorfolkNorfolkVirginia23502-
Northwest Clinical Research CenterBellevueWashington98007-

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