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LY3451838

Phase 2

Migraine | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Nov 28, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04498910A Study of LY3451838 in Participants With MigrainePHASE2 COMPLETED 38Nov 16, 2020Nov 9, 2022Nov 28, 20239 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in the Number of Monthly Migraine Headache Days During 1-Month
Baseline, Month 1

Migraine Headache Day is a calendar day on which a migraine or probable migraine headache occurs. Per International Headache Society \[IHS\] International Classification of Headache Disorders version 3 \[ICHD-3\], migraine is defined as a headache, with or without aura, of \>=30 minutes duration with both of the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Least square mean was assessed using Bayesian Mixed Model Analysis with baseline number of monthly migraine headache days as a covariate.

Secondary Endpoints
Change From Baseline in the Number of Monthly Headache Days During 3-Month
Baseline, Month 3
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days
Month 1
Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Baseline up to 5 Months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1500 milligrams (mg) LY3451838EXPERIMENTALParticipants received a single intravenous (IV) dose of 1500 mg LY3451838.
PlaceboPLACEBO_COMPARATORParticipants received a single IV dose of placebo.
Interventions
NameTypeDescription
LY3451838DRUGAdministered IV
PlaceboDRUGAdministered IV
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Must have a diagnosis of migraine with a history of migraine headaches of at least 1 year prior, and migraine onset prior to age 50. * Have completed at least 80% of required daily diary entries during the start of the study. * Have documentation of previous failure of 2 to 4 ...

Countries:United States
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