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Capsaicin

Phase 1

Migraine Disorders | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Apr 9, 2019

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02766517Biomarker Study in Participants With MigraineEARLY_PHASE1 COMPLETED 37 — — Sep 28, 2016Jan 1, 2017Apr 9, 201914 United States
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Study Endpoints
Primary Endpoints
The Capsaicin-Induced Dermal Blood Flow (DBF)
Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993

Change from pre-capsaicin DBF adjusting for vehicle at 30 minutes is reported. The capsaicin induced dermal blood flow (DBF) was measured by laser Doppler imaging (LDI).

Plasma Calcitonin Gene-Related Peptide (CGRP) Levels
On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993

The mean Plasma Calcitonin Gene-Related Peptide levels were reported.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
CapsaicinEXPERIMENTALSingle topical dose of capsaicin
Interventions
NameTypeDescription
CapsaicinDRUGAdministered topically
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Participants with migraine who have previously participated in study NTC02163993 and received one of the selected doses of galcanezumab or placebo * Have suitable skin characteristics for the dermal capsaicin challenge Exclusion Criteria: * Have a history of significant alle...

Countries:United States
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