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LY3451838

Phase 2

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

LY3451838 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Oct 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

LY3451838 clinical trials

LY3451838 · 1 trial · 1 indication

Phase 2 1
NCT04498910A Study of LY3451838 in Participants With MigraineMigraine
COMPLETED38 Analytics
PHASE2COMPLETED
A Study of LY3451838 in Participants With Migraine
MigraineUnlock trial analytics

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 to 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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Competitive Landscape -Migraine 43 trials

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Frequently asked questions about LY3451838

What is LY3451838?

LY3451838 is an investigational small molecule being developed by Eli Lilly and Company for migraine. It has been studied in a Phase 2 clinical trial and is not yet approved. The program is in clinical development, with one completed trial of 38 participants.

What is LY3451838 used for in migraine?

LY3451838 is being studied as a treatment for migraine. It is an investigational small molecule developed by Eli Lilly and Company. The only reported trial enrolled 38 adults with migraine in the United States, and the drug has not been approved for any use.

Who makes LY3451838?

LY3451838 is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the developer of the investigational small molecule for migraine.

What phase is LY3451838 in?

LY3451838 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The drug remains investigational and has not been approved by the FDA for migraine or any other indication.

What clinical trials is LY3451838 in?

LY3451838 has been studied in one completed Phase 2 trial, NCT04498910, titled A Study of LY3451838 in Participants With Migraine. The trial enrolled 38 adults, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.