The reason for this study is to see if the study drug LY3451838 is safe and effective in participants who have migraine that have not responded to other preventive treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
21st Century Neurology, a division of Xenoscience
Phoenix, Arizona, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Renstar Medical Research
Ocala, Florida, United States
Change From Baseline in the Number of Monthly Migraine Headache Days During 1-Month
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.
Time frame: Baseline, Month 1
Change From Baseline in the Number of Monthly Headache Days During 3-Month
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.
Time frame: Baseline, Month 3
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days
Percentage of Participants with ≥50% Reduction from Baseline in Monthly Migraine Headache Days are reported.
Time frame: Month 1
Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
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Emerald Coast Center for Neurological Disorders
Pensacola, Florida, United States
University of South Florida
Tampa, Florida, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Clinvest Research LLC
Springfield, Missouri, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Health Research of Hampton Roads Inc
Newport News, Virginia, United States
Number of Participants with at least one TEAEs are reported. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline up to 5 Months
Number of Participants With at Least One Serious Adverse Events (SAEs)
Number of Participants with at least one SAEs are reported. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline up to 5 Months
Pharmacokinetics (PK): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Serum Concentration (AUC 0-t) of LY3451838
PK: AUC(0-t) of LY3451838
Time frame: Pre-infusion, end of infusion, 3hours(h), 365h, 730h, 1095h, 1460h, 1825h, 2190h, 2920h, 3650h post-infusion
PK: Maximum Observed Serum Concentration (Cmax) of LY3451838
PK: Cmax of LY3451838
Time frame: Pre-infusion, end of infusion, 3hours(h), 365h, 730h, 1095h, 1460h, 1825h, 2190h, 2920h, 3650h post-infusion