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Capsaicin

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

Capsaicin · 1 trial · 1 indication

Early Phase 1 1
NCT02766517Biomarker Study in Participants With MigraineMigraine Disorders
COMPLETED37 Analytics
EARLY_PHASE1COMPLETED
Biomarker Study in Participants With Migraine
Migraine Disorders
NCT0276651737
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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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Frequently asked questions about Capsaicin

What is Capsaicin used for in migraine?

Capsaicin is an investigational small molecule being studied for the treatment of migraine disorders. It is currently in Phase 1 clinical development, with one completed early Phase 1 trial. The drug is not yet approved and remains under investigation for this neurological condition.

Who makes Capsaicin?

Capsaicin is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical research to evaluate the drug's potential in treating migraine disorders.

What phase is Capsaicin in?

Capsaicin is in Phase 1 clinical development for migraine disorders. A single early Phase 1 trial has been completed, involving 37 participants. The drug is investigational and has not received regulatory approval for any indication.

What clinical trials is Capsaicin in?

Capsaicin has one completed clinical trial, NCT02766517, titled 'Biomarker Study in Participants With Migraine.' This early Phase 1 study enrolled 37 participants in the United States and was not randomized, double-blind, or controlled.

Is Capsaicin FDA approved?

Capsaicin is not FDA approved for migraine disorders. It is an investigational drug currently in Phase 1 clinical development. The completed early Phase 1 trial, NCT02766517, was a biomarker study, and further research is needed to establish safety and efficacy.